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The food choice at work study: effectiveness ofcomplex workplace dietary interventions ondietary behaviours and diet-related disease risk -study protocol for a clustered controlled trialGeaney et al.

Geaney et al. Trials 2013, 14:370http://www.trialsjournal.com/content/14/1/370

TRIALSGeaney et al. Trials 2013, 14:370http://www.trialsjournal.com/content/14/1/370

STUDY PROTOCOL Open Access

The food choice at work study: effectiveness ofcomplex workplace dietary interventions ondietary behaviours and diet-related disease risk -study protocol for a clustered controlled trialFiona Geaney1*, Jessica Scotto Di Marrazzo1, Clare Kelly1, Anthony P Fitzgerald1, Janas M Harrington1, Ann Kirby2,Ken McKenzie3, Birgit Greiner1 and Ivan J Perry1

Abstract

Background: Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunityexists to implement these interventions in the workplace. The overall aim is to assess the effectiveness andcost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or incombination with nutrition education in large manufacturing workplace settings.

Methods/design: A clustered controlled trial involving four large multinational manufacturing workplaces in Cork willbe conducted. The complex intervention design has been developed using the Medical Research Council’s frameworkand the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TRENDstatement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic‘nudge’ theoretical perspective. Nutrition education will include three elements: group presentations, individualnutrition consultations and detailed nutrition information. Environmental dietary modification will consist of fiveelements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) pricediscounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. Nointervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C willreceive nutrition education and environmental dietary modification. Workplace D will receive environmentaldietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent,full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietarybehaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4months, 7 to 9 months and 13 to 16 months will be recorded. A process evaluation and cost-effectiveness economicevaluation will be undertaken.

Discussion: A ‘Food Choice at Work’ toolbox (concise teaching kit to replicate the intervention) will be developed toinform and guide future researchers, workplace stakeholders, policy makers and the food industry.

Trial registration: Current Controlled Trials, ISRCTN35108237

Keywords: Environmental modification, Nutrition education, Fat, Salt, Sugar, Workplace, Workplace complex dietaryintervention

* Correspondence: [email protected] of Epidemiology and Public Health, University College Cork,4th Floor Western Gateway Building, Western Road, Cork City, IrelandFull list of author information is available at the end of the article

© 2013 Geaney et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.

Geaney et al. Trials 2013, 14:370 Page 2 of 14http://www.trialsjournal.com/content/14/1/370

BackgroundAltering people’s health-related behaviours can have asubstantial impact on the main causes of mortality andmorbidity [1]. Behavioural interventions can modify currentpatterns of disease [1]. Diet-related disease is a major publichealth concern and continues to endanger our populationhealth and the sustainability of our healthcare systems [2].Dietary intake of fat (especially saturated fat and trans fat),sugar and salt play a critical role in the development ofhypertension, obesity, type 2 diabetes and cardiovas-cular disease [3].Dietary behaviour is influenced by a complex net of

individual, environmental, societal, biological and psycho-logical factors [4,5]. Given the complicated intricacies ofdietary behaviour, there is a need to develop effectivecomplex behavioural interventions to promote dietarychange in the population. Complex interventions haveseveral interacting components and should be deve-loped systematically with appropriate evidence andtheory [1,6]. These interventions should be pilotedcarefully and the process of implementation should bemonitored [6].The workplace is an ideal setting to implement these

complex interventions, as most adults spend approximately60% of their waking hours at work [7]. The workplaceenvironment is a microcosm of society [8]. It is the mostappropriate setting to examine complex dietary inter-ventions as it can tolerate the interacting componentsof these interventions while assessing the impact inrelatively homogenous workplace populations in con-trolled environments [8]. Relevant reviews agree thatthese interventions may be more effective if they areof high intensity, developed within a complex frameworkand comply with a robust study design [5,8-12].However, there are substantial gaps in the current

evidence base [8-13]. Although a moderate positiveeffect on dietary behaviour has been reported, particu-larly with fruit and vegetable intakes [9-12], workplacedietary intervention studies to date are of low-intensitywith suboptimal study designs [9-13]. These interven-tions focus on information provision and fail to examineenvironmental approaches, such as food modificationand real incentives, for example, price discounts [8].Inconsistent reporting of previous studies has alsoprecluded meta-analysis. Therefore, the impact ofcomplex workplace dietary behaviour interventions isstill unknown.The aim of this study is to assess the effectiveness

and cost-effectiveness of complex dietary interventionsfocused on environmental dietary modification aloneor in combination with nutrition education in largemanufacturing workplace settings. The study design isinformed by the findings of a systematic review con-ducted by the authors [14].

This high-intensity complex intervention design is guidedby appropriate structured frameworks and guidelines,including those of the Medical Research Council [6] andthe National Institute for Health and Clinical Excellence(NICE) [1]. This study will be reported according to theTREND statement [6,15].Environmental dietary modification and nutrition edu-

cation approaches in this study will primarily draw on asoft paternalistic ‘nudge’ theoretical perspective [16]. Asrecommended by the World Health Organization, cater-ing and workplace stakeholders, including employees,will actively develop aspects of the intervention with theresearch team according to the specific characteristicsof the included workplaces [4].A process evaluation will be conducted. A cost-

effectiveness economic evaluation will be undertaken ineach workplace following a previous framework devel-oped by Drummond et al. [17]. Very few studies haveused cost-effective techniques to evaluate workplaceinterventions. Recently, Sacks et al. found that thetraffic-light nutrition labelling offered excellent valuefor money as an obesity-prevention measure [18]. Ab-senteeism trends will also be monitored before andafter the intervention to measure differences in labourproductivity.

Study hypothesisWorkplace complex dietary interventions that combineenvironmental dietary modification and nutrition educa-tion are more effective and cost-effective than nutritioneducation interventions alone or environmental dietarymodification interventions alone when considering posi-tive changes in dietary behaviour, health status and diet-related disease risk.

Study objectivesThe key objectives for this study are:

1. To develop long-term workplace complex dietaryinterventions focused on environmental dietarymodification alone or in conjunction with nutritioneducation in large manufacturing workplace settingsand evaluate the impact of these interventions onemployees’ dietary behaviour, health status andnutrition knowledge.

2. To investigate employees’ food choice motives in aworking environment.

3. To conduct a process evaluation that will includeall key stakeholders to define critical elements inthe success or failure of the complex dietaryinterventions.

4. To evaluate and compare the alternativeinterventions in terms of their costs andconsequences.


Methods/designThe complex intervention design has been developed andwill be evaluated using the Medical Research Council’sframework [6]. The four phases of the framework aredevelopment, feasibility and piloting, evaluation, andimplementation; these are illustrated in Figure 1.

DevelopmentThis phase focuses on (1) identifying the evidence base,(2) identifying and developing a theoretical understand-ing, and (3) modelling the process and outcomes for thecomplex intervention.

Identifying the evidence baseWe conducted a systematic review on the impact ofworkplace dietary modification interventions alone or incombination with nutrition education [14]. The reviewwas guided by the PRISMA statement [19]. Althoughthere was evidence that some interventions can moder-ately increase fruit and vegetable consumption, resultsshow that uncertainty remains regarding the long-termeffects on dietary behaviour, health status and economiccost. The systematic review findings informed the inter-vention design.

Identifying and developing theoryThis intervention design will comply with a soft pater-nalistic ‘nudge’ theoretical perspective [16]. The inter-vention will create positive reinforcement with indirectsuggestions for healthy food choices to try to improve

(D) Implementation1. Surveillance and2. Long-term follow3. Dissemination

(A) Development1. Identifying the evidence base2. Identifying/developing theory3. Modelling process and

outcomes

(B) 1. Testing proced2. Estimating rec3. Determining s

Feasibility/pilo

Figure 1 Medical Research Council’s framework: ‘Developing and evaluatdesign has been developed and will be evaluated using this framework.

dietary behaviour with unforced compliance. Environ-mental engineering approaches will be guided by choicearchitecture that will include food modification, reloca-tion of healthy food options and price discounts.

Modelling process and outcomesThis behavioural complex intervention design is guidedby the detailed principles and recommendations of theNICE guidelines [1]. The study focuses on two potentialmethods to improve long-term dietary behaviour in theworkplace including environmental dietary modificationand nutrition education. Both methods will be measuredindependently and collectively in purposively selectedworkplaces. Workplace A (the control) will continue tofollow usual practice. No changes will be implemented.Workplace B will receive nutrition education. WorkplaceC will receive nutrition education and environmentaldietary modification. Workplace D will receive environ-mental dietary modification alone. The intervention designhas been developed by the research team (nutritionists,dieticians, public health and health promotion researchers),catering stakeholders in Ireland (representatives of theCatering Managers Association of Ireland), workplacestakeholders (catering managers, human resources man-agers, occupational health managers) and the targetpopulation, that is manufacturing employees. Figure 2illustrates the trial design.Study outcomes will assess the effect of the intervention

on dietary behaviours and improvements in diet-relateddisease risk. Primary outcomes will include changes in

(C) Evaluation1. Assessing effectiveness2. Understanding change process3. Assessing cost-effectiveness

monitoring-up

uresruitmentample size

ting

ing complex interventions: new guidance’. The complex intervention

Implementation of complex dietary interventions

Workplace A

Control

No changes to be implemented.

Workplace B

Nutrition education only

1.Monthly group presentations

2.Individual nutrition consultations (healthy eating booklet)

3.Healthy eating chat tables

4.Detailed nutrition information:- Monthly posters/ leaflets- Monthly emails- Healthy eating traffic light

coding system - Quizzes - Shopping card- Personal measurement

card

Workplace C

Environmental modification + nutrition education

1.Restriction of fat, saturated fat, sugar and salt

2.Increase fibre, fruit and vegetables

3.Price discounts for whole fresh fruit

4.Strategic positioning of healthier alternatives

5.Portion size control

6.Provide nutrition education (all elements of workplace B)

Workplace D

Environmental modification only

1.Restriction of fat, saturated fat, sugar and salt

2.Increase fibre, fruit and vegetables

3.Price discounts for whole fresh fruit

4.Strategic positioning of healthier alternatives

5.Portion size control

Clustered controlled trial Unit of delivery: workplace

Enrolment: Large workplaces assessed for eligibility

Final workplaces selected (n=4)

Baseline data collectionPhysical assessments: BMI, WC, BP, urine analysis Food frequency questionnaire (FFQ)Two 24-hr dietary recalls (within 1 week) Health, lifestyle + food questionnaire Process evaluation Economic evaluation (EQ-5D)

Allocation of workplaces

Follow-up 7-9 months + 13-16 months: All baseline assessments repeated

Statistical analysisNetWisp 4: Food and nutrient analysis

Stata: Pearson chi-square analysis, ANOVA, mixed effects modelling, latent class analysis

Follow-up 3-4 months: Physical assessments (BMI, WC, BP), two 24-hr dietary recalls (within 1 week), Food motives questionnaire (FMQ), Dutch Eating Behaviour Questionnaire (DEBQ)

Figure 2 Food Choice at Work trial design.


dietary behaviour and health status. Analysis of multiple24-hour dietary recalls, food frequency questionnaires,food sales data and food purchasing patterns will indicatechanges in dietary behaviour. Changes in body mass index(BMI), waist circumference, resting blood pressure andurinary electrolytes, including sodium and potassium(24-hr urine collections and random urine samples) willhighlight improved health status outcomes. Secondaryoutcomes will determine food motives [20] and eatingbehaviours [21], changes in nutrition knowledge [22] andeconomic cost outcomes. A cost-effectiveness economicevaluation will be conducted and absenteeism trendswill be recorded during the study period.

InterventionsEach workplace will have a research workplace leader whowill be based on-site for the duration of the study. Theworkplace leader will collaborate with the workplacestakeholders to co-ordinate the study and monitor dailyadherence to the interventions.

Nutrition education in workplaces B and CNutrition education will include three components grouppresentations, individual nutrition consultations and de-tailed nutrition information.Group presentations will consist of monthly ‘lunch and

learn’ group nutrition sessions (30 minutes per session)

Figure 3 Traffic-light display. The traffic-light coding system willbe applied to all food menus in workplaces that will implement thenutrition education intervention. The coding system will display thenumber of calories and traffic lights will show the amount of fat,saturated fat, total sugars and salt per portion size of the meal orfood item. Traffic-light threshold values are guided by the Food SafetyAuthority of Ireland (FSAI) and the Food and Drug Administrationlabelling system.


and will be delivered to all employees. These sessionswill concentrate on portion control, reading food labels,general healthy eating, and reducing sugar, salt and fatdietary intakes. Sessions will be repeated a number oftimes per month so that all participants in all shifts havethe opportunity to attend. Peer support and group dis-cussion will allow for more effective learning.Individual dietary counselling (20 minutes per session)

with a nutritionist or dietician will be conducted witheach participant at baseline, and follow-up sessions heldat 3-4 months, 7-9 months and 13-16 months. Thenutritionist or dietician will provide advice on how tofollow a healthy diet, reach or maintain a healthy BMIand achieve or maintain a healthy resting blood pres-sure. The individual consultation will be based on theparticipant’s individual lifestyle, health status results(weight, BMI, waist circumference) and dietary recallassessments. The ‘Food Choice at Work’ healthy eatingbooklet will be offered to each participant at the endof the first consultation. The booklet will support nu-tritional advice during consultations.A ‘healthy eating chat table’ will be situated outside the

canteen during break times twice a month. All employeeswill have the opportunity to sit and ask a nutritionist ordietician about healthy eating.Detailed nutrition information will be offered throughout

the duration of the intervention using six key methods:(a) posters and leaflets, (b) emails, (c) menu labelling,(d) quizzes, (e) shopping cards, and (f) personalized meas-urement cards.Posters and leaflets will be displayed throughout the

workplace and based on the theme of the ‘lunch andlearn’ monthly nutrition sessions. This information willbe replaced monthly.Monthly emails will be disseminated to all employees

using the workplace intranet to inform the employees ofthe scheduled activities for that month.A unique healthy eating traffic-light coding system will

be applied to the daily menus in the employees’ canteensand vending machines on-site. The coding system willdisplay the number of calories and traffic lights will showthe amounts of fat, saturated fat, total sugars and salt perportion size of the meal or food item. The traffic lightswill also be displayed in words for employees who arecolour blind (Figure 3).All traffic-light threshold values will be based on the

Irish nutrient goals from the Food Safety Authority ofIreland (FSAI) and the Food and Drug Administrationlabelling system. The Irish nutrient goals have been devel-oped on the basis of a caloric intake of 2000 kilocalorie(kcal) per day [23]. The recommended percentage intakeis: for fat, 20% to 35% (<80 g); for saturated fat, <10%(≤20 g); for total sugar, ≤20% (≤90 g); and for salt, ≤6 g[23]. A green light will be applied if the food or meal

does not exceed 5% of the recommended percentageintake. An amber light will be applied to a food or mealthat contains between 5% and 20% of the recommendedpercentage intake. A red light will be applied if the food ormeal exceeds the limit of 20% of the recommended per-centage intake.Two short quizzes focused on the traffic-light displays

and the ‘lunch and learn’ group nutrition sessions will begiven to all employees each month. Randomly selectedwinners will receive free lunches.Pocket-sized food choice shopping cards will be offered

after baseline assessments. These cards will provide guid-ance on how to select healthy food choices when purchas-ing food at work or outside of work using our own uniquetraffic-light coding system.Pocket-sized personal measurement cards (pocket size)

will be offered after baseline assessments to allow partic-ipants to log and follow their progress throughout thestudy regarding their health status. Individual dietaryadvice from the nutrition consultations will also be re-corded on the card.

Environmental dietary modification in workplaces C and DThe menus in workplaces C and D will be nutritionallyanalyzed using NetWISP software (Weighed Intake Soft-ware Program; Tinuviel Software, Warrington, UK) beforethe study commences. The workplace stakeholders andthe research team will discuss and reach a consensuson all future environmental dietary modifications inthe workplace canteens and vending machines. Tastetesting will be conducted by the workplace stakeholdersand the research team before the implementation of anymodifications. All catering staff will be trained beforeand during the intervention period so there is high com-pliance with the specific dietary modifications and por-tion control.The following five environmental dietary modifications

will be recommended: (a) restriction of fat, saturated fat,


sugar and salt, (b) increase in fibre, fruit and vegetables,(c) price discounts for whole fresh fruit, (d) strategicpositioning of healthier alternatives and (e) portion sizecontrol.For the restriction of fat, saturated fat, sugar and salt,

all menus need to be modified. Stock and bouillonshould be removed from all recipes and replaced with arecommended low-salt stock. Salt should be eliminatedfrom all cooking processes. Fresh herbs, spices and gar-lic should be introduced to develop additional flavour.Savoury options that are high in salt, saturated fat andfat should be restricted (for example, sausage rolls, crois-sants) and replaced with low-fat or low-salt options. High-salt products (gravy mixes, stock cubes) and processedmeats (bacon, corned beef) will be reduced and replacedwhere possible with low-salt options (turkey, chicken,fish). Fresh herbs, spices and garlic will be introduced todevelop additional flavour. Ready-made meals will beremoved and replaced with freshly cooked options. Full-fat dairy products (that is milk, cream, cheese and butter)will be replaced with low-fat options where possible.Cheese and cream will not be used as a garnish onmeals. The amount of cheddar cheese will be reduced inall dishes. Cooking methods with oil, such as deep-fatfrying, will be limited and will be replaced with methodsof boiling, poaching, grilling, steaming and baking wherepossible. Only plant oils will be used in cooking (that is,rapeseed, olive, canola and other plant oils). Full-fatmayonnaise will be replaced with low-fat mayonnaise insandwiches and other lunch options.No sauces or accompaniments will be added to any

meal unless the employee requests it. Chips and Frenchfries will be removed from the menus two days a weekand replaced with different potato options, for examplebaked potatoes. Pizzas will be removed from the menusthree days a week. All desserts will be fruit-based. Softcarbonated drinks will be restricted and replaced withwater, milk and unsweetened fruit juice options.To increase fibre, fruit and vegetables, white pasta, rice

and bread will be replaced with wholegrain alternatives.Fruit and vegetables will be added to rice, pasta, soupand meat dishes. A buffet-style fresh salad bar will beavailable to accompany any dish daily. Fresh whole fruitwill be available throughout the day.Portions of whole fruit will be offered at discount

prices.To introduce portion size control, workplaces will be

recommended to comply with the FSAI guidance onportion size [23]. Training will be provided to all cater-ing staff regarding strict portion size control. Standardserving tools will be used by caterers and employees tocontrol portion size at mealtimes.Healthier alternatives will be strategically positioned:

healthy snacks, such as whole fresh fruit, dried fruit,

nuts without chocolate, salt or sugar, brown sandwiches,brown soda bread and seeds will be positioned at eyelevel at the entrance of the canteen and in the vendingmachines. Chocolate, sweets, biscuits and crisps will berestricted and replaced where possible with healthy snacksin the canteen and in the vending machines located inthe canteen. Full-size chocolate bars will be replacedwith smaller options. Salt will be removed from thetables and will be replaced with sachets.

Feasibility and pilotingThe second phase includes (1) testing procedures, (2) esti-mating recruitment and (3) determining an appropriatesample size.

Testing proceduresIn 2009, we carried out a cross-sectional comparisonpilot study in two public hospitals in Cork, Ireland; oneof which had implemented a long-term (2 years) cateringintervention designed to reduce dietary fat, saturated fat,sugar and salt intake. All menus were modified. High-salt products (gravy mixes, stock cubes) and processedmeat (bacon, corned beef ) were replaced with low-saltoptions (turkey, chicken and fish). Fresh herbs, spicesand garlic were introduced. Salt was removed in cook-ing. Saltcellars were removed from the tables in thecanteen but small salt sachets were available at the ser-vice counter. Nutrition information was displayed in thecanteen area. No sauces were added to any meals withoutthe employee’s consent. All desserts were fruit-based. Staffmembers were encouraged to consume extra salad andvegetable options at no extra cost. Cooking methodswith oil were reduced. No catering changes were imple-mented in the second hospital.A total sample of 100 random employees aged 18 to

64 years (50 from each hospital) who consumed at leastone main meal in the hospital staff canteen daily tookpart in the study. Dietary intakes and sociodemographiccharacteristics were assessed. Reported mean intakes oftotal sugars, total fat, saturated fat and salt were signifi-cantly lower in the intervention hospital when adjustingfor age and sex. Estimated average salt intake in theintervention hospital (5.6 g/day) did not exceed thetolerable upper limit of 6 g/day vs. a mean salt intakeof 6.7 g/day in the non-intervention hospital.The study findings, published in the journal Public

Health Nutrition [24], suggest that a structured cateringinitiative sustained over a relatively long period mayinfluence long-term positive food choices at work andat home. Although these findings should be interpretedcautiously given the small sample size, many of the pro-posed dietary environmental modification and nutritioneducation components of the ‘Food Choice at Work’ study


have been shown to be acceptable and feasible in a work-place setting.

Validation study A validation study to assess the accuracyof the 24-hour dietary recall method for calculating dietarysalt intakes will be conducted after baseline data collection.CK will carry out a validation study to assess the accuracyof the study’s 24 hour dietary recalls for estimations of diet-ary salt intake in comparison with the 24-hour urinarysodium excretion method, spot urine samples and foodfrequency questionnaires.

Estimating recruitmentA four week period in each workplace will be allocatedto estimate recruitment. The time taken to scheduleemployees and conduct baseline data collection appoint-ments will be recorded to inform the other stages of datacollection.

Determination of sample sizeA decrease in BMI by 1 kg/m2 (1 unit) and a 2 g averagefall in dietary salt intake would have population healthsignificance and clinical significance in terms of the riskof diet-related disease, for example, hypertension. To de-tect this difference in BMI between the control and inter-vention groups at follow-up session after 7 to 9 and 13 to16 months and assuming a common standard deviation of3.77, it is estimated that a sample size of 448 (112 perworkplace) would have 80% power at the 5% significancelevel (findings from a previous study show that a 1 kg/m2

difference was independently associated with 13% higherrisk for hypertension) [25,26]. The study will also be ad-equately powered (80% power at the 5% significance level)to detect a fall in dietary salt intake between the controland intervention groups at follow-up periods of 7 to 9 and13 to 16 months using a standard deviation of 4.2 (In aprevious intervention study the response within eachparticipant group was normally distributed with standarddeviation 4.2) [27].

EvaluationThe third phase is concerned with assessing the (1) effect-iveness of the interventions, (2) understanding the changeprocess and (3) assessing the cost-effectiveness of thecomplex intervention.

Effectiveness of the interventions

Study design Effectiveness of the interventions will beevaluated using a clustered controlled trial design in fourlarge manufacturing multinational workplaces based inCork in the Republic of Ireland with a representativesample of employees.

Study duration The total study duration is 16 months,with the interventions being delivered over a 9-monthperiod. Follow-up is for 6 months post-intervention.

Unit of analysis While the data will be collected at theindividual level, the primary unit of analysis will be atthe workplace level. Standard errors will be adjusted forclustering within the four workplaces before calculatingconfidence intervals.

Recruitment A comprehensive list of manufacturingcompanies in Cork in the Republic of Ireland will beobtained from the Industrial Development Authority ofIreland (IDA) website. Workplaces will be systematic-ally selected from the A to Z listing. As the focus of thestudy is to implement a complex dietary intervention inan ideal environment, workplaces will be purposivelyselected and allocated. Only workplaces and employeesthat meet the specified selection criteria will be recruited.

Inclusion criteria Any manufacturing multinational work-place that employs more than 250 employees and has adaily workplace canteen for employees can be includedin the study. The workplace must be located in Cork,represented on the Industrial Development Agency (IDA)website and able to commit to all components of thecomplex intervention for the duration of the study.Any permanent, full-time employee who is contracted towork for the duration of the study period and purchasesand consumes at least one meal in the main canteendaily will be eligible to participate in the study.

Exclusion criteria All non-manufacturing nationalworkplaces that employ less than 250 employees or donot have a workplace canteen; are not represented in theIDA website; not located in Cork or not able to committo the intervention design for the study period will beexcluded.Employees will be excluded if they:

1. Work part time.2. Do not have contracts to work during the study

period.3. Do not work in the workplace full-time (for example,

work from home 2 days a week).4. Travel regularly for work (more than once a month).5. Do not purchase and consume a main meal from

the staff canteen daily.6. Are medically advised not to participate in the study.7. Are involved in an on-going diet programme external to

work (for example, the Weight Watchers programme).

Data collection methods All data collection will takeplace during paid working hours (excluding employees’


breaks). To measure the effects on the primary andsecondary outcomes, data will be collected in fourstages using questionnaires, dietary and physical as-sessments and face-to-face semistructured interviews.Baseline assessments will be conducted prior to imple-mentation of the intervention. Follow-up assessments willbe carried out at 3 to 4 months, 7 to 9 months and 13 to16 months.

Questionnaires Four questionnaires will be self-completedby each participant electronically or in a hard-copy for-mat. All questionnaires are based on validated, pre-testedquestionnaires and will be completed at various studytime-points.The Health, Lifestyle and Food Questionnaire (HLFQ)

is organized into ten different sections (A to J). SectionsA, B, and C relate to the participant (sex, age, ethnicity,education), and include details of work life (permanentor temporary, job arrangement) and general healthstatus (self-rated health, health conditions and self-ratedweight) [27] Sections D, E and F relate to the partici-pant’s usual dietary patterns at home and at work.Sections G, H and I investigate the participant’s usuallifestyle patterns including physical activity (using theInternational Physical Activity Questionnaire), smokingand alcohol questions [28]). Section J will focus on theparticipant’s nutrition knowledge using the GeneralNutrition Knowledge Questionnaire (GNKQ) [23]. Thequestionnaire will take approximately 25 minutes tocomplete.The Food Motives Questionnaire (FMQ) will investi-

gate motives underlying the selection of food [20]. Itconsists of nine scales, including health, mood, conveni-ence, sensory appeal, natural content, price, weightcontrol, familiarity and ethical concern. This question-naire will help understand the causes of variation indietary intake among participants. This questionnairewill take five minutes to complete.The Dutch Eating Behaviour Questionnaire (DEBQ) is

a validated eating behaviour scale to assess restrained,emotional and external eating behaviour [21]. The ques-tionnaire will take three minutes to complete.The EuroQol-5D (EQ-5D) is a standardized instru-

ment for use as a measure of health outcome. Applicableto a wide range of health conditions and treatments, theEQ-5D health questionnaire provides a simple descriptiveprofile and a single index value for health status [29].EQ-5D is primarily designed for self-completion byparticipants and is ideally suited for use in onlinesurveys and face-to-face interviews.

Dietary assessments The 24-hour dietary recall methodwill quantitatively measure current nutrient intake overa period of 24 hours, including the workplace and the

home environment. Little burden is placed on theparticipant as this method requires short-term memoryonly but it fails to measure habitual diet. The FoodFrequency Questionnaire tool is used to measure habi-tual dietary intake. It is a quantitative instrument andthe most commonly used dietary assessment in largescale epidemiologic surveys.The Food Frequency Questionnaire (FFQ) will be self-

completed by each participant electronically or in a hard-copy format at baseline and follow-up at 7 to 9 monthsand 13 to 16 months. The FFQ is an adapted version ofthe European Prospective Investigation of Cancer FFQ[30]. It has been used extensively in the Irish populationincluding the Irish Surveys of Lifestyle, Attitudes andNutrition [28] and the original Cork and Kerry baselinestudy in 1998 [31] and the baseline Phase II Cork andKerry study in 2010 [32]. The FFQ is designed to assessthe whole diet and includes 150 food items arranged intothe main food groups. Respondents will be asked to rec-ord their average frequency of consumption of each fooditem over the last year. Typical weights, portion sizes andnutrient intake will be based on recommendations estab-lished by the Food Standards Agency (2002) [33] andMcCance and Widdowson’s Food Composition Tables[34,35]. A specifically designed programme, NetWISP4©(Weighed Intake Software Program; Tinuviel Software,Warrington, UK), will convert dietary information to foodquantities and nutrient values [36,37].The 24-hour dietary recall method will be a modified

version of the validated UK 24 hour dietary recall method[38]. Two dietary recalls will be collected within one weekto examine on- and off-work-duty dietary patterns atbaseline, and follow-up periods of 3 to 4 months, 7 to9 months and 13 to 16 months.The three-step method will outline specifically what

the participant had to eat and drink in the previous24 hour period.

1. Quick list: participants will be asked to reporteverything that they had to eat or drink the daybefore their appointment (midnight to midnight).

2. The nutritionist or research assistant will collectdetailed information on items named in the quicklist (consumption time, place of consumption, brandand recipe), foods likely to be eaten in combination(milk in coffee) and the quantity consumed and anyleftovers or second helpings.

3. Recall review: participants will have an opportunityto provide additional information or to refer tofoods forgotten in the quick list.

Finally, the interviewer will ask the participants abouttheir consumption of water and food supplements. Allinformation gathered is recorded in a food consumption


record. Additional modifications added to the methodinclude specific prompts to measure salt and oil con-sumption. Each 24-hour dietary recall data collectionwill take approximately 20 minutes to complete. Finally,the nutritionist or research assistant will complete aninterviewer evaluation. Each food, drink and portionsize will be coded according to the 24-hour coding in-structions based on the validated UK method. Food andnutrient analysis will be calculated using NetWISP4©(Weighed Intake Software Program; Tinuviel Software,Warrington, UK) [36,37].

Physical assessments Each participant will be asked toparticipate in a physical assessment where BMI, (midway)waist circumference, waist hip ratio and resting bloodpressure will be measured.

Resting blood pressure Blood pressure measurementswill be obtained using the Omron M7 Digital BloodPressure monitor. It is a compact, fully automatic monitor,operating on the oscillometric principle. This method ofmeasurement determines the participant’s blood pressureby measuring the pressure fluctuations caused by thepulse waves. Before the measurement begins, the par-ticipant will be seated and as relaxed as possible withboth feet parallel and flat on the floor. The researcherwill ensure that the participant has not been smoking orparticipating in any vigorous exercise prior to the meas-urement. A full bladder also affects a blood pressurereading, so the researcher will give the participant anopportunity to void prior to measurement.The researcher will instruct the participant to remove

any tight clothing covering the upper arms and ensurethat the participant has been seated and settled for approxi-mately 5 minutes prior to commencing the procedure. Themeasurements will be taken on the right arm wheneverpossible. The participant’s arm will rest on a desk so thatthe antecubital fossa (a triangular cavity of the elbow jointthat contains a tendon of the biceps, the median nerveand the brachial artery) is at the level of the heart andthe palm is facing up. The participant must always feelcomfortable. The greatest circumference of the upperarm will be measured for a suitable cuff, with the armrelaxed and in the normal blood pressure measurementposition (antecubital fossa at the level of the heart), usingan inelastic tape. Three measurements will be taken fromeach participant one minute apart.

Urine analysis Spot urine samples will be obtained foranalyses of sodium, potassium, urea and creatinine levels.Two spot urine samples will be obtained from each indi-vidual at baseline and follow-up periods of 7 to 9 and 13to 16 months (six spot samples in total per participant).Each participant will provide one sample from the evening

before their on-duty 24-hour dietary recall and theirsecond sample will be the first sample voided on themorning of their dietary recall. The urine samples will betaken approximately 12 hours apart, for example, 8 pmand 8 am.A subsample of participants from each workplace will

be asked to complete a 24-hour urine collection the daybefore their on-duty 24-hour dietary recall at baselineand at follow-up periods of 7 to 9 and 13 to 16 months.24-hour urinary sodium excretion is considered the goldstandard method for estimating dietary salt intake. It isestimated that between 90% and 95% of dietary saltintake is excreted in urine. Para-aminobenzoic acid, abiologically inert substance that is rapidly excreted inurine, will be administered to all participants on theday of urine collection to validate the completeness ofthe 24-hour collection sample. To estimate total sodiumexcretion in the spot urine samples, the sodium contentwill corrected for total 24-hour urine volumes calculatedfrom the validated 24-hour urine samples collected.

Statistical analysis Data will be recorded manually andentered electronically into a Stata statistical software pack-age prior to statistical analysis. Data manipulation andstatistical analyses will be conducted using Stata. Primaryanalysis will examine the effects of the interventions bymeasuring changes in dietary behaviour, health statusoutcomes and nutrition knowledge.Data regarding individual and environmental factors

that may influence the effectiveness of the dietary com-plex interventions will be collected during baseline andfollow-up. Individual factors will include personal (age,sex, ethnicity, education status, nutrition knowledge), life-style (smoking status, alcohol consumption, physicalactivity) and workplace factors (shift-work patterns, workstatus, for example, production worker, work schedule).Environmental factors will include the employees (sexbreakdown and age profile) and the workplace structure(number of employees in workplace, canteen arrangement,for example, opening hours, employee structure, for ex-ample, percentage of employees working in production).Proportions in workplaces A, B, C and D will be com-

pared using Pearson’s chi-square and McNemar’s test forpaired data. Mean levels of macronutrients, fibre, salt,fruit and vegetable intake in workplaces A, B, C and Dwill be compared and analyzed using a repeated measureanalysis of variance (ANOVA) model. To measure nutri-tion knowledge, all participant responses to the GNKQwill be coded numerically and converted to a correctedscore, as defined by Parmenter and Wardle [22].A mixed effects model will examine subject variation

in the longitudinal trends in dietary behaviour, exploreassociations between trends in dietary behaviour andhealth status over time in workplaces A, B, C and D and


adjust for the potential confounding effect of otherfactors such as age, sex and shift-work patterns. Thecost-effectiveness economic evaluation will be completedusing a similar framework to Drummond et al. [17] andRoberts et al. [39].

Planned subgroup analysis Secondary analysis will in-vestigate external factors that may be associated with theeffects of the interventions. Subgroup analysis will lookfor possible differential effects in different employee dis-ciplines (that is, production employees versus management)and work groups that is, shift workers versus day workers).Analysis will be conducted across workgroup-strata andeducation level as a proxy measure of social class. Dietarypattern analysis will be conducted using latent class analysis[40]. It will identify mutually exclusive subgroups withindifferent dietary classes. Latent class analysis will estimateeach participant’s probability of belonging to a particulardietary class. A change in these subject-level probabilitiesis evidence of changes in dietary behaviour and prefer-ence. Changes in dietary preferences will be compared inall workplaces and associations with clinical and behav-ioural outcomes will be examined.

Understanding change process: process evaluationThe implementation of the intervention will be monitoredwith a detailed process evaluation throughout the inter-vention period. A subsample of key workplace stake-holders from each workplace will be involved in a processevaluation to define critical elements in the success orfailure of the complex dietary interventions through theuse of semistructured interviews. Workplace stakeholders(catering managers, human resources managers, occupa-tional health managers and employee representatives) willinclude individuals who have been exposed to the inter-vention either by participation or have been involved inthe development of the study design.Semistructured interviews will be conducted with par-

ticipants for one hour at baseline and follow-up after 7 to9 and 13 to 16 months. Further to this, the researcherstasked with implementing the study will also be involvedin the on-going process evaluation. They will participatein focus groups and document study activities on aweekly basis.The process evaluation will explore opinions on effective

strategies to promote healthy eating at work, determineparticipants’ perceptions of the implementation of theinterventions in their workplace settings and examinethe workplace stakeholders’ awareness of changes in theworkplace and changes in their dietary patterns forthe duration of the intervention.The process evaluation plan will be directed by Steckler

and Linnan’s conceptual framework [41]. The topic guidewill be based on the following six components: fidelity,

dose delivered, dose received, reach, recruitment and con-text. With informed participant consent, the interviewsand focus groups will be digitally recorded, transcribedand analyzed using NVIVO software (QSR InternationalPty Ltd). A framework approach will be used for dataanalysis [42]. This method is appropriate given that thestudy has pre-specified objectives but it will also allowfor unexpected themes to emerge [43].

Assessing cost-effectiveness: economic evaluationA framework similar to that described in Drummond et al.[17] and Roberts et al. [39] will be used to measure thecost-effectiveness of each intervention. Seven steps willbe followed:

1. Describe each program alternative, its componentsand potential benefits.

2. State the perspective from which the programmeswill be analyzed. The principal costs of theinterventions are the advice by the nutritionists andthe toolbox (resources used for implementation ofinterventions: training, equipment). If these costs areborne by the businesses, then the perspective will bethat of the business and their staff (the businessbenefits from lower sick days, the staff from betterhealth). If the health service bears these costs, thenthe perspective is that of the health service (it bearsthe costs, but sees an improvement in populationhealth, which is the primary objective of the healthservice). Thus the perspective adopted will dependon who is bearing the costs and reaping the benefits.

3. Identify, measure and value the costs of thealternatives. The main costs will be the toolbox, theon-going advice of nutritionists to construct ahealthy cost-neutral menu and the printing costs forprovision of information. Identification involves thelisting of all resources used; measurement capturesthe resources used in physical units and valuationputs prices on these physical resources. We will alsomeasure sick days for each employee the year beforethe intervention and the year after the interventionand compare the two results to measure whetherthere is a difference.

4. Identify, measure and value the outcomes of thealternatives. The primary outcome will be quality oflife as measured using EQ-5D. A secondary outcomewill be BMI. Some of the health status outcomesdata are already collected in Work Stream 1 withquestions on BMI and waist circumference included.

5. Future costs and outcomes will be discounted at theappropriate discount rate. In Ireland this is taken at3.5% and in the UK it is 5%.

6. Decision analytical modelling will be used to assessparameter uncertainty and heterogeneity. For


instance, quality-adjusted life years will be calculatedbased on a combination of the quality of life scoresemerging from the EQ-5D measurement and thenumber of life years saved, based on extrapolation ofthe changes in BMI. The uncertainty surroundingthese estimates will be appropriately modelled.

7. Incremental cost-effectiveness ratios will be calculatedfor each of the alternatives and analysis of relativevalue for money will be reported. This and othermeasures of value for money, such as net benefit,will be presented in a decision analytical framework.

ImplementationThe fourth phase concentrates on (1) surveillance andmonitoring, (2) long-term follow-up and (3) dissemination.

Surveillance and monitoringAs the workplace leaders will be based in the workplaceduring the study period, they will observe and enforceall components of the intervention and record a weeklylog of the intervention activities. The workplace leaderswill meet with the workplace stakeholders on a weeklybasis. The workplace leaders will inform the ‘Food Choiceat Work’ logistics committee.The ‘Food Choice at Work’ logistics committee will

meet monthly in each workplace to monitor the efficiencyof day-to-day data collection, harmonize communication,discuss concerns relating to the study design and data,discuss training of the research team and participant orstakeholder safety. Members will include the projectmanager, lead investigator (FG), workplace leader, humanresources representative, occupational health and safetymanager, employee representative and catering managerfrom each workplace.The steering and data monitoring committee will meet

once every two months. Members will include the leadinvestigator, principal investigator, co-investigators (withexpertise in nutritional science, behavioural science, healtheconomics, epidemiology, public health and biostatistics),the project manager and workplace leaders. The com-mittee will monitor the study; oversee day-to-day ethical,data and administrative management; monitor compliancewith the intervention and discuss dissemination. Quarterlyprogress reports relating to budget forecasts and fieldworkprogress will be made.An oversight committee will meet quarterly to review

study deliverables and outputs, ensure that accurate, timelyand appropriate reporting and problem solving occurs.Financial management will also be discussed. Memberswill include the principal investigator (IJP), lead investi-gator (FG), project manager, representative from theoffice of research and innovation and the finance de-partment in the University of College, Cork, Republicof Ireland.

Long-term follow-upThe complex interventions will be implemented over a9-month period and long-term follow-up will take placeat 3 to 4 months, 7 to 9 months and 13 to 16 months(6 months post-intervention). We feel that 16 monthsis necessary to measure the sustainability of changes indietary behaviour but if additional funding is available, wewould consider a further follow-up phase at 24 months.

DisseminationFuture academic dissemination will occur through a rangeof academic international peer reviewed journals. Nationaland international conferences will be attended to dissem-inate research findings using posters and oral presenta-tions. Employees in the included studies will be informedby email. We will use modern social media technology,including a ‘Food Choice at Work’ Facebook page andregular tweets from our study Twitter account to informthe general public. Noteworthy findings will be publishedin future press release to inform the public, food industryand public health policy makers. A ‘Food Choice at Work’toolbox (concise teaching kit to replicate the intervention)will be developed to inform and guide future researchers,relevant stakeholders and policy makers.

Threats to validitySelection biasSelection bias will be minimized in this study. Allemployees will be masked to the study hypothesis.Employees will be informed of a university-led studyobserving employees’ general dietary intakes over a 13to 16 month period. No additional information will beprovided to employees about the study design. Partici-pants will be randomly selected using random numberallocation software.

Information biasThis study is open to information bias including recallbias and interviewer bias.

Recall bias It is not feasible to adequately blind studyparticipants to the changes in their workplace environ-ments, for example traffic-light labelling, therefore recallbias may be an issue. Participants will be interviewed bythe research team in a standardized manner. The vali-dated questionnaires are designed to measure potentialco-founders and co-factors associated with the effective-ness of these interventions. Outcomes will be measuredobjectively where possible. Changes in health status willbe measured using BMI, waist circumference, restingblood pressure and urinary electrolytes. Economic cost willbe monitored using absenteeism trends and changes inprofit margins in the workplace canteens will be recorded.


Interviewer bias It is not possible to adequately blind theresearch team to the allocation of workplaces. Therefore,it is possible that the research team may act differentlydepending on the workplace allocation. To minimizethis bias, the research team will be adequately trainedand retrained at specific time-points to comply with acohesive protocol to ensure all data is collected in astandardized manner. Data will be continuously moni-tored to ensure that research members are not invitinga systemic error (bias) into the data.

Side-effect reporting and quantificationReporting will adhere to the TREND guidelines [6,15].No adverse events are envisaged for participants. The fieldwork will be carried out in compliance with a detailedstandard operating procedures manual. All field researchemployees will receive formal training for dietary andphysical assessments at baseline and retraining beforefollow-up periods to ensure standardization of processesand procedures. All scales, tape measure and automatedblood pressure monitors will be calibrated and recordedat the start of the study and recalibrated monthly inaccordance with the manual.Urine samples (24 hour urine collections and spot urine

samples) will be assayed for electrolytes in an accreditedhospital laboratory. The manual explains in specific detailthe standard duty of care for abnormal blood pressure andurine results. The first priority will always be the healthand wellbeing of the participant. A physician workingwith the Department of Epidemiology and Public Health,University College Cork, Republic of Ireland will overseeall 24 hour urine collection results and advise accordingly.

DiscussionThe ‘Food Choice at Work’ study is the first high-intensity,complex dietary intervention study to measure the effect-iveness and cost-effectiveness of environmental modifica-tion and nutrition education over a long-term period insimilarly structured controlled manufacturing workplaces.This unique study will be developed and evaluated accord-ing to an established academically rigorous frameworkand has the potential to improve dietary behaviour, nutri-tion knowledge and reduce the risk of diet-related disease.

StrengthsThe study is developed using systematic theory and anevidence base. It is developed and evaluated accordingto the TREND statement (an academic framework rec-ommended by the Medical Research Council’s and NICEguidelines [6,15]).The study has a participatory approach, and includes

catering and workplace stakeholders in the study designand evaluation. It has a complex ‘high-intensity’ interven-tion design including a unique traffic-light coding system

based on recommended portion size. Intensive trainingwill be provided for the research team and caterers (work-places C and D).There is no risk of contamination, as all employees

work in different companies located in different geo-graphical areas.There is a triangulation of methods. The dietary, health

status and knowledge assessments will provide descriptiveand contextual data on changes due to the intervention,while the semistructured interviews will deepen ourunderstanding of the process of the implementationaccording to the perspectives of key stakeholders withinthe intervention workplace.Various outcome measures will be used to assess changes

in dietary behaviour and health status (objective and self-reported measures). Objective measurements include BMI,resting blood pressure and urine analysis (24-hour urinecollection and spot urine samples). Self-reported measuresinclude the completion of questionnaires (HLFQ, FFQ,FMQ, DEBQ and EQ-5D).The study will have a thorough process evaluation and

extensive cost-effectiveness economic evaluation. Studyprogress will be monitored by the logistics committee inall workplaces and the steering committee.

LimitationsThe study design is not randomized. However, the char-acteristics of each workplace are similar, including workschedules (shift patterns), company type (production andoffice based), skilled and educated workforces. Demo-graphic information from the questionnaires will deter-mine further comparison between worksites. The samplewill also be randomly selected from the employee lists.There is no concealment of allocation. The workplaces

were purposively selected to ensure that all componentsof the interventions could be implemented successfully.There is a lack of blinding: given the nature of the work-

place interventions (nutrition consultations or environmen-tal change), it is not possible to adequately blind personnelor participants. Participants will be masked to the studyhypothesis.There is a selection bias: healthy employees may be

more likely to participate but demographic variables ofnon-responders will be examined to ensure the partici-pants are representative of the general workforce.Recall bias and social desirability bias may be evident,

given that both dietary measurements (FFQ and 24-hourdietary recall) are self-reported. Dietary data may be over-estimated or underestimated. The FFQ will be completedby the participant without the presence of the researcher.The 24-hour dietary recall method is clearly structuredwith specific food prompts so recall bias may be prevented.The researcher will start each visit with the 24-hour dietary


recall and will not comment about food before the recallso social desirability bias may be reduced.

Implications for research and practiceThe Food Choice at Work interventions may improve theincluded employees’ dietary behaviours and reduce theirdiet-related disease risks. This study will provide criticalevidence of the effectiveness of workplace complex inter-ventions in the promotion of healthy dietary behavioursin the manufacturing working population. It may assistin the development of future guidelines to improve dietarybehaviours in the workplace and will inform future re-searchers. It may influence national and internationalcatering stakeholders, policy makers and motivate the foodindustry to provide healthier food choices. If the findingsare positive, it may reduce diet-related disease developmentand the burden on the healthcare system in the Republicof Ireland. The large multinational manufacturing compan-ies included in the study have similar worldwide structuresand operations; the findings, therefore, will be generalizablenationally and transferable internationally. Following studycompletion, it is planned to examine the transferability ofthis complex intervention in a European or global context.

EthicsEthical approval was granted by the Clinical ResearchEthics Committee of the Cork Teaching Hospitals in theRepublic of Ireland in May 2012 and was amended inMarch 2013. Permission has been granted by the managingdirectors and catering managers in all workplaces. Informedconsent will be obtained from all participants prior toparticipation in the study.

Trial statusRecruitment of participants is on-going (July 2013).Data collection will not be completed until at leastDecember 2014. Trial registration: Current ControlledTrials ISRCTN35108237.

AbbreviationsANOVA: Analysis of variance; BMI: Body mass index; DEBQ: Dutch Eating BehaviourQuestionnaire; EQ-5D: EuroQol-5D; FFQ: Food Frequency Questionnaire;FMQ: Food Motives Questionnaire; FSAI: Food Safety Authority of Ireland;GNKQ: General Nutrition Knowledge Questionnaire; HLFQ: Health, Lifestyle andFood Questionnaire; IDA: Industrial Development Authority of Ireland;kcal: Kilocalorie; NICE: National Institute for Health and Clinical Excellence.

Competing interestsThe authors declare that they have no competing interests.

Authors’ contributionsFG was primarily responsible for the final content of the paper and is theguarantor. FG, JSDM, BG, KMcK and IJP worked on the study design. AKdesigned the methods for the cost-effectiveness economic evaluation. JMH,IJP, JSDM, CK and FG were involved in developing the data collectionmethods. APF and FG were responsible for the sampling methods and dataanalysis plan. FG and IJP co-wrote the paper. All authors approved the finalversion of the paper for publication.

AcknowledgementsThe authors extend their sincere thanks to all workplace stakeholdersinvolved in the design of the dietary interventions.

Funding sourcesThis work is supported by the HRB Centre for Health & Diet Research grant(HRC2007/13) which is funded by the Irish Health Research Board and by theDepartment of Agriculture, Fisheries and Food. Student bursaries have beenawarded from the Irish Heart Foundation and the Nutrition and HealthFoundation to students involved in the study.

Author details1Department of Epidemiology and Public Health, University College Cork,4th Floor Western Gateway Building, Western Road, Cork City, Ireland.2School of Economics, University College Cork, Cork, Republic of Ireland.3School of Psychology, Trinity College Dublin, Dublin, Republic of Ireland.

Received: 3 July 2013 Accepted: 15 October 2013Published: 6 November 2013

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doi:10.1186/1745-6215-14-370Cite this article as: Geaney et al.: The food choice at work study:effectiveness of complex workplace dietary interventions on dietarybehaviours and diet-related disease risk - study protocol for a clusteredcontrolled trial. Trials 2013 14:370.

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