2011

Assessment of dietary compliance among patients with type II diabetes receiving text message (SMS) reminder vs. those who do not receive text message

reminder

A Randomized control trial

PROTOCOL FOR THESIS RESEARCH

Gulshan.Bano.eb1003

P R O T O C O L

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ContentsTitle:.............................................................................................................................................3

Background:.................................................................................................................................3

Introduction of Diabetes:.............................................................................................................3

Prevalence of diabetes on a Global scale:....................................................................................3

Prevalence of diabetes in developing world:...............................................................................3

Management of diabetes:.............................................................................................................4

Role of text messages in disease management:...........................................................................5

Rationale:.....................................................................................................................................6

Research question:.......................................................................................................................6

Hypothesis:...................................................................................................................................6

Aim:.............................................................................................................................................7

Objective:.....................................................................................................................................7

Methodology:...............................................................................................................................7

Study setting:................................................................................................................................7

Study design:................................................................................................................................7

Study population:.........................................................................................................................7

Eligibility criteria:........................................................................................................................8

Variables......................................................................................................................................8

Independent variables:.................................................................................................................8

Dependent variable:...................................................................................................................10

Other variables (co-variates):.....................................................................................................11

Plan of operation:.......................................................................................................................12

Identification of the study participants:.....................................................................................12

Tools used to identify the participants (Eligibility form):.........................................................12

Complete data collection tools:..................................................................................................13

Data collectors:..........................................................................................................................13

Detailed procedure and follow up:.............................................................................................13

Sample size calculation:.............................................................................................................14

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Plan of analysis:.........................................................................................................................15

Data Management and Quality Control:....................................................................................16

Training of the data collectors:..................................................................................................16

Pretesting of questionnaire:........................................................................................................16

Quality control of Data:.............................................................................................................16

Data editing:...............................................................................................................................16

Data entry and cleaning:............................................................................................................17

Ethical considerations:...............................................................................................................17

Written consent:.........................................................................................................................17

Confidentiality and rights of the participants:............................................................................17

Ethical approval:........................................................................................................................17

Follow chart:..............................................................................................................................18

References:.................................................................................................................................18

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Title:“Assessment of dietary compliance among patients with type II diabetes receiving text

message (SMS) reminder vs. those who do not receive text message reminder, a randomized control trial”

Background:

Introduction of Diabetes:

Diabetes is a metabolic disorder, characterized by raised blood glucose either when the pancreas

does not produce enough insulin or when the body cannot effectively use the insulin.

Hyperglycemia or raised blood sugar is a common effect of uncontrolled diabetes and over time

leads to serious damage to many of the body's systems, especially the nervous system and Cardio

vascular system.

There are two major types of diabetes, type I and type II. Type I diabetes (formerly called

insulin dependent diabetes mellitus, IDDM or child onset diabetes) is a life-long condition,

affecting children, young people and adults worldwide. Type II diabetes is closely linked with

sedentary life style and obesity[1].

Prevalence of diabetes on a Global scale:

It was estimated that there are over 300 million people suffering from diabetes around the world.

This total is expected to reach close to 500 million within next 20 years. Each year a further 7

million people develop diabetes.[2]

More than 80% of diabetes deaths occur in low and middle-income countries. WHO projects

that, diabetes deaths would double between 2005 and 2030 [3]. The number of deaths

attributable to diabetes in 2010 shows a 5.5% increase over the estimates for the year 2007. This

increase is largely due to a 29% increase in the number of deaths due to diabetes in the North

America & Caribbean Region, a 12% increase in the South East Asia Region and an 11%

increase in the Western Pacific Region [4].

Prevalence of diabetes in developing world:

It was estimated that during 2010 and 2030 there would be 69% increase in the number of cases

of diabetes in developing countries while only 20% increase would be in developed countries.[5]

In developing countries, around half of the people with diabetes are diagnosed without timely

and adequate treatment, leading to exponential rise in complications and morbidity from diabetes

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[4]. As compared to other regions of the world, prevalence of diabetes is very high in Asia. It

was estimated in 2010 that the regional prevalence was 7.0%, and it was expected to increase up

to 8.4 % by 2030 [6]. India and China are considered to have the highest prevalence of diabetes

worldwide. With an estimated 50.8 million people living with diabetes, India has the world’s

largest diabetic population followed by China with an estimated 43.2 million diabetic people [4].

A study was conducted in India, which shows that the prevalence in females was 16.7% while in

males it was 9.7% [7]. In 2003 the prevalence in Pakistan was 6.2%, while it was expected at

that time that it would increase to 11.6% in 2025 [8]. In 2010 national prevalence in Pakistan

was 7.6%, whereas comparative prevalence was 9.1% according to international diabetic

association [9]. We can assume that by 2025 the prevalence would be higher than expected, since

it is increasing very rapidly.

A study suggest in Pakistan overall glucose intolerance (DM+IGT) was 22.04% in urban and

17.15% in rural areas. In rural and urban areas, both males and females are suffering from

diabetes [10]

Management of diabetes:

Various methods are available worldwide to manage diabetes, but the disease cannot be

permanently cured. Around the world majority of the diabetic patient are being treated with

drugs (oral medications and Insulin), physical activity, and diet. Use of Insulin is higher in

patients with severe conditions because it is difficult to manage with oral medication and

behavioral methods in such severe situations. Oral medication can only control the disease in

moderate situations. But there are several side-effects reported with the oral hypoglycemic drugs

and Insulin. Troglitazone is an oral drug which can cause liver toxicity [11] and Acarbose is

responsible for flatulence and diarrhea [12].Various studies provide evidences about treating

patients with Insulin increases the weight of the patients [13], which is an adverse effect on the

prognosis of the disease. But it has been proven that the combined treatment of diabetes i.e.

physical activity and dietary counseling with medication is more beneficial [14]. Evidence shows

that physical activity plays a major role in both prevention and prognosis of majority of chronic

diseases i.e. diabetes and cardiovascular diseases [15]. Physical activity includes brisk walking,

exercise, and any type of activity which makes an individual physically active can contribute to

better health of a person. Likewise diet control can play a major role in prognosis as well as

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sugar control [16]. Both come under the modifiable risk factors. Both physical activity and diet

can be modified in order to manage the medical conditions of diabetes. Diet can deteriorate as

well as help in prognosis of the disease. But it’s up to the care provider which type of diet he/she

prescribes for the patient. Especially in case of diabetes, taking care of one’s diet is very

important. Diet can control the glucose level [16] and body weight of a diabetic patient, but more

counseling and motivation is needed for its effectiveness [17]. Weight loss improves condition of

diabetic patients by lowering the blood glucose levels [18]. Both body composition and weight

of the patient can be modified and the diabetes can be managed with the help of dietary

guidelines and proper monitoring. Dietary guidelines should be very clear and well structured, in

order for the patients to understand and adhere. This effort also requires proper counseling and

monitoring of the patient and other resources. Proper monitoring is very important to motivate

the person to achieve the goal.

Role of text messages in disease management:

Enormous use of media and other electronic devices in recent times has shown success in

motivating the patients to improve their health behavior. Examples of such technologies include

television, Internet [19, 20] and mobile phones [21]. Studies have been done on the use of mobile

phones in the tertiary health care settings in developed countries, especially in diabetic

individuals, proved that it can improve the blood glucose levels by motivating the patients to

adhere to the treatment [22]. A review study was conducted in 2009 (included published studies

between January 1990 and March 2008) on behavior change interventions delivered by mobile

telephone short-message service, showing 33 such studies, out of which 14 met their inclusion

criteria. 4 out of 14 studies reviewed targeted preventive health behaviors (e.g. smoking

cessation [23]), and 10 focused on clinical care (e.g. diabetes self-management). According to

this review and an another article, positive behavior change outcomes were observed in 13 of the

14 studies [24]. Various studies have been done on electronic SMS to manage incurable diseases

like diabetes, with the help of behavior modification intervention. These studies prove that by

motivating patients with reminders through SMS can improve both adherence and conditions of

the participants [25, 26].

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Rationale: In the developing countries specially in Pakistan, prevalence of diabetes mellitus is high, and the largest age group currently affected by diabetes is the middle age people.[4] Usually the diagnosis is done in late stages in developing countries because the population always comes to the health facilities when the conditions get worse. Therefore, after the occurrence of the disease, we need to develop certain strategies in order to improve the quality of life. In case of diabetes mellitus, proper counseling for dietary intake soon after the diagnosis plays a major role not only in improving the glycemic index, but also the quality of life of the individual. Unfortunately, in our communities, people ignore the importance of such interventions due to various factors, either because they give preference to house chores and family over their own health, or forget to follow the guidelines. Hence there should be proper techniques and methods with the help of which they could be reminded about their health in their busy routines. In the developed countries, as mentioned above, such techniques have been successfully applied while in developing world it is not that much common. Use of electronic communication is very common in our country especially through mobile phones. We can thus use text messages to spread awareness for different health conditions. It is also a cheap and feasible way to improve health condition of a person. To the best of our knowledge, no such study of reminding the diabetic patients about their dietary guideline via text message had been done in the past in our country. With the help of this study we would be able to assess the compliance to the dietary guidelines in the diabetic patients who receive text message vs. the diabetic patients who do not. This would help in developing the policies of continuous reminding for different chronic health conditions to improve the standard and quality of life of the individuals.

Research question:Is there any difference in compliance to dietary guidelines among patients with type-II diabetes who receive both written guidelines and text messages, compared to those who receive only written dietary guidelines?

Hypothesis:Compliance to dietary guidelines among patients with type-II diabetes, who receives electronic messages, would be different by a score of 1.5 as compare to those patients who do not receive text messages. [24, 27-30].

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Aim:

To assess whether text messages related to dietary management of diabetes care improve the health of patients with type-II diabetes attending Aga Khan hospitals in Karachi Pakistan

Primary Objective:

To assess the difference in dietary compliance in patients with type-II diabetes, who were reminded through text message (SMS) vs. those not reminded.

Secondary objectives:

To assess the change in HBA1c in both the groups To assess the change in fasting blood glucose levels of participants in both the groups. To assess dietary compliance in participants who will respond to text messages vs. those

who will not respond to text messages.

Methodology:

Study setting:

This study would be carried out at the Aga Khan University and Hospital (AKUH) stadium road.

Study design:

This would be a single blinded, randomized controlled trial. There would be two arms, one

would be the intervention arm and other would be the control arm. The intervention group would

receive dietary guidelines, counseling and a text message reminder, and the control group would

receive only dietary guidelines and its counseling. Study participants would be randomly

assigned to either arm with block randomization (of varying length) technique. Text messaging

would be used to improve the compliance to dietary guidelines. Text messaging would be sent on

the mobile phones of the participant by using Frontline Short Message Service (SMS) software 3

times a week for 3 months.

Study population:

The overall population of this study would be all diabetic patients, while the source population

would be all the diabetic patients coming to AKUH. Among these patients my focus would be on

the target population, those diabetic patients who have been diagnosed and conformed as a

known case of diabetes in the last 2 to 15 years. After applying the eligibility criteria, I would be

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able to achieve the required sample size for the study to assess the compliance to the dietary

guidelines.

Eligibility criteria:

Inclusion:

Patients of age between 30 to 70 years

Patients with an HbA1c more than 7.

Cases diagnosed with type-II diabetes since 2 to 15 years.

Those patients who have mobile phone and do not intend to change their phone number in

the next six months

Those who can read the SMS written in Urdu and will be able to respond to it.

Those who are on oral hypoglycemic medication only.

Exclusion:

Serious chronic co-morbidities e.g. Diabetic ketosis, Severe Diabetic foot, Nephropathy, Neuropathy, Retinopathy (taking injectable hypoglycemic drugs), chronic Renal failure, Liver cirrhosis.

Those who cannot give consent.

Not able to understand Urdu or English. Enrolled in any other study Pregnant females Hearing and verbal disabilities

Variables

Independent variables:

Intervention:

Text message reminder would be sent to the participant three times a week for three months.

These would be automated messages similar for all the participants in the intervention arm, and

sent out at the same time. We would use Frontline-SMS software to deliver the messages. There

would be different template each time. Some of the examples of the template are following:

1. Sweets and carbonated beverages/cold drinks: eat small amounts of these foods, once or

less times in a week.

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2. Vegetables and fruits: choose most of your foods from these foods.

3. Choose whole grain products and cereals. Etc.

1. Technical part of the intervention:

1. Software: We would use ‘Frontline-SMS’ software to send the messages to a large

number of people at one time. This is award-winning free and open source software that

turns a laptop and a mobile phone into a central communication hub. Once installed, the

program enables user to send and receive text messages with groups of people through

mobile phones. It stores all the phone numbers and records all the incoming and outgoing

messages and also it insures that massage has been delivered.

2. Hardware: We would use a computer and an EDGE USB to connect the mobile sim card

with the Frontline-SMS.

2. Dietary Guidelines (DG):

We made these dietary guidelines under the supervision of senior dietician at AKUH. It would be

provided to both intervention and control group in the form of a pamphlet. Detail counseling

regarding guidelines would be done in both arms at the time of face to face meeting.

Food components Portion size frequency Note: If any

Cereal, starch and whole grain foods

1serving = 1 slice bread/ 1/2 chapatti/ 1/2 cup cereal/ 1/2 cup boil rice

3 servings/day

Vegetable 1 cup cooked and 1/2 cup raw

2 servings /day

Fruits 1 fruit( equals to 1/2 cup Pomegranate/ 1 cup Water Melon/ 1 cup Papaya/ 4-5 strawberries/ 1/2 medium Grape fruit/ 1 medium Guava/ 1 medium Peach/ 1 medium Apple/ 1 medium Pear/ 1 medium Orange/1/2 Banana/ 6-8 medium Jaman / 1 medium Cheeko / 2-3 Dates

2 times/day( only two fruits are allowed in one day)

Nuts and legume 1 serving = 1 cup dall/ 2 Servings /day

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3 almonds/ 1 walnut/ 3-4 peanuts

Fish, poultry and eggs 1 serving=1 small piece of fish (1 ounce)/ 1/2 cup chicken (1 ounce piece)/1 small egg

1 – 2 servings/day

Dairy products 1 serving = 1 glass milk (skim) /1 cup yogurt (should be low fat)/1/2tsp. butter or oil

2 servings/day

Meat products ½ cup meat ( 1 ounce piece)

Use sparingly 1 – 2 time/week

Sweets and drinks 1 small Use sparingly 1 time / week (better to avoid)

Dependent variable:

Outcome variable:

Compliance to dietary guidelines would be the outcome in both the groups, which would be

measured by using the food frequency questionnaire (FFQ). Dietary compliance is a state of

being in accordance with established dietary guidelines (DG). FFQ would be conducted at the

baseline as well as after the intervention period (3 months). There would be 8 main components

of FFQ e.g. Vegetables, Fruits, Cereal, starch and whole grain foods, Nuts and legumes, Dairy

products, fish, poultry and eggs, Meat products and Sweets and drinks. Each component would

contain many food items. Daily consumption of each food item would be collapsed to find out

the average daily intake of each component. We would assign the scores to each component

(range would be from 0 to 2). If the proportion of the consumption of food component would be

exactly equal to the dietary guidelines, it would be assigned score 2. If the consumption would be

greater or lesser than the dietary guidelines, we would assign 1 score. If there would be no

consumption at all than we would assign “0” score.

After the complete assignment of scoring, total scores for all FFQ would be calculated by adding

the scores of all the 8 components. The overall possible scoring for FFQ would range from 0 to

16 (there are 8 components and highest possible score for each component is 2 and lowest is 0).

Total scores of each FFQ would be than compared this score scale (0 to 16).

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Other variables (co-variates):

Age:

Age would be assessed in complete years and considered as a continuous variable. It associated

with both intervention as well as outcome, as age increases a person’s ability to respond to the

text messages and following the dietary guidelines both can be affect.

Education:

We would assess education with questionnaires as a categorical variable i.e. primary, secondary,

higher secondary and graduation. It can also affect the dietary compliance.[31]

Social support:

Social support is defined as the perceived availability of people whom the individual trusts and

who make one feel cared for and valued as a person[32].Questionnaire would be used to assess

the social support[33]. Open ended question would be used. Social support can alter the

results[34], because it can motivate a person more or less than our reminders[35].

BMI:

It would be assessed by measuring weight and height (wt in kg/ ht in meters square) with weight

and height scales. Patients with high BMI are unable to control on diet as compare to those with

normal BMI[36].

Family income:

It would also be assessed by questionnaires as a continuous variable. It matters a lot in case of

dietary compliance[37]. Those patients who would be able to purchase vegetable and fruits

which are very expensive in our setting would only be able to follow guidelines. In case of low

income families, usually only one meal is cooked for the entire household, than it would be

difficult for the lady to adhere to dietary guidelines.

Number of physician’s visit:

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Number of visit would be asked from the participant, because it can affect the dietary intake of a

person. As we know that if the physician visit increases it can affect the outcome of our study.

Depression and anxiety:

It can also affect the outcome, if a person would be depressed he would not be able to follow the

guidelines even after reminding him/her, hence would affect the compliance[38]. We would

measure the depression and anxiety with the help of the HAD scale (hospital setting) which is

available online on internet. This scale is developed for hospital setting by Zigmond and Snaith.

[39]

Plan of operation:

Identification of the study participants:

The study would identify the potential participants from AKUH. We would take the permission

from AKUH for this concern. We would visit the identified place and we would identify the

participants by interviewing and we would also confirm eligibility from their medical history.

Details of the blood glucose level and contacts including address and telephone numbers would

be recorded. We would collect the details of only those participants who were diagnosed in the

last 3 to 10 years. We would include those participants who would be on oral medication, in case

if the participant would change the treatment after inclusion in the study i.e. shifted to insulin

during the study, would not be followed farther.

Tools used for eligibility of the participants (Eligibility form):

To identify the potential participant, an eligibility questionnaire would be used while reviewing

the medical charts after agreement of the participant. This questionnaire would be used on the

bases of diagnostic criteria used at AKUH laboratory to assign the participant as diabetic. Those

participants would be considered as diabetic if their blood fasting glucose would be more than

126mg/dl or 7mmol/l and 2 hours would be more than 200mg/dl or 11.1mmol/l. This

questionnaire would also include medical history of the participant, which would help us in

identifying eligible participants. We would include those participants who would be on oral

medication, in case if the participant would change the treatment after inclusion in the study i.e.

shifted to insulin during the study, would not be followed farther.

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Complete data collection tools:

At the baseline we would conduct the interview of each participant for both socio-demographic

(using a questionnaire) and dietary intake using food frequency questionnaire, social support

questionnaire and anxiety and depression scale. We would also measure the anthropometric

details of the person, including height, weight, waist and hip circumference in order to assess the

body mass index.

As we mentioned in the methodology part that there would be two interviews of the participant

for FFQ, one at the baseline and the other at the end of the intervention period, for that reason we

would use a semi quantitative food frequency questionnaire, which has been developed for use in

both, urban and rural population of Karachi by Dr. Romaina Iqbal for PURE study. This FFQ

contains both traditional and mix dishes of our country. It is based on 8 components of food

groups e.g. Vegetables, Fruits, Cereal, starch and whole grain foods, Nuts and legumes, Dairy

products, fish, poultry and eggs, Meat products and Sweets and drinks.

Data collectors:

Two data collectors would be identified for the data collection. Data collectors would be well

trained staff, who can understand and speak Urdu properly in order to conduct interviews and fill

the questionnaires. Proper training for the main objectives of the study would be given to the

data collector. Data collector would be responsible to fill the eligibility forms from the medical

records of the participant, to collect the information regarding the contact details of the potential

participants, and to take the interviews from the participants about the demographic and dietary

intake information.

Detailed procedure and follow up:

We would identify the potential participants from setting (mentioned above) by taking

information about the status of the disease both from online records and from each participant.

We would inform the participants (in person) about our study in detail. If the participant would

agree to participate, then he/she would be given a copy of consent form with our signature,

which would contain detailed information about the study. We would confirm the eligible cases

by reviewing their files at the clinic after taking informed consent. Those who are eligible for our

study based on the eligibility criteria would be interviewed. A 26 minutes interview would be

conducted in the procedure room or a clinic to maintain the privacy and confidentiality. This

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interview would contain food frequency questionnaire, socio-demographic questionnaire, social

support scale and anxiety and depression scale. After collecting the baseline interviews, all the

potential participants would be provided with dietary guidelines and its detail counseling. After

interview and counseling we would take the mobile numbers of all the participants in order to

send reminder messages. We would send messages in Urdu format. The participants would then

be randomized to either arm i.e. intervention and control. Randomization would be performed

via computer generated random numbers. A block randomization strategy with an uneven

varying block size of multiples of 2 would be used. This technique would take care of

predictability of the allocation of the participants. Participants in the intervention group would

receive 3 different text messages in a week. A fortnightly question would be sent to assess the

dietary intake of specific food components in both the groups. This question should be responded

by the participants. For their response we would send them credit through easy loads. Both the

groups would be followed for three months.

We would inform the participant that they can’t change their sim card during the study period. In

case the mobile phone is lost, they would be requested to inform us as soon as possible.

We would conduct interim analysis after the completion of one half month. We will conduct the

outcome by using FFQ and via telephone calls. After completion of three months intervention

period (follow up) we would conduct the final FFQ in order to measure the dietary compliance

from both the groups via telephone calls. Data collectors would be blinded to the status of the

participants. They would not be disclosed that in which group they are conducting the interviews.

For secondary objective, we would review the files of potential participants in detail to record

HbA1c and fasting blood glucose. If we are able to find for participants, we would record the

recent HbA1c and fasting blood glucose of the participant at the baseline of the study, and after

the completion of intervention period. We would compare the HbA1c and fasting blood glucose

in both the groups to see the effect of the intervention.

Sample size calculation:

With 5% level of significance and a difference of 1.5 score between the two groups, we need 112

subjects in each arm to achieve 80% power of the study. To the best of my knowledge there have

been no such study done in diabetes participants. So we calculated this sample size by dividing

the total range of compliance score with 4 to calculate the standard deviation and we considered

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that there would be at least 1.5 score difference between the intervention and control group. We

considered the literature during making the assumption for this purpose, especially from the

studies which have a similar study intervention and design [29, 30] . The final sample size after

considering 10% loss to follow-up would be 248 participants.

Plan of analysis:

Exposure of interest: Mobile text message with dietary guidelines

Outcome of interest: Dietary compliance

By taking into consideration the above exposure and outcome, analysis would be as follow:

Frequencies with percentages for the categorical variables including education, occupation,

depression and anxiety and social support would be computed for both intervention and control

group. Descriptive analysis would also be performed for the outcome of interest (dietary

compliance) in a similar manner. Means or medians and standard deviations with inter quartile

range whatever would be appropriate for continuous variable i.e. age and house hold income

would be generated for both the arms.

Univariate analysis would be conducted by computing unadjusted relative risk (RR) and their

95% confidence intervals (CI) to compare the two groups. Appropriate test based on the

assumptions (distribution of the data) would be used to assess the association between the mobile

text messages and dietary compliance and other variables as well. For multivariable analysis we

would set a criteria of p-value of <0.25 to include the variables in the analysis. We would also

assess the multicolinearity between the independent variables. Multiple linear regressions would

be performed to compute the adjusted RR with 95% CI. During this analysis we would assess the

interaction between the variables and based on the biological plausibility all possible

confounders would be identified. For all the association p-vale of <0.05 would be considered

significant. And also we will do a subgroup analysis for objectives other than the primary

objective. We will compare both groups for HbA1c and fasting blood glucose by using an

appropriate test. We will also compare the groups for dietary compliance of those who respond

to the text messages and those who do not. This subgroup analysis would be done only for those,

for which we will be able to get the HbA1c and fasting blood glucose.

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In case of missing data, we would exclude it if it would be negligible otherwise, it would be

handled with the help of imputation

Data Management and Quality Control:

Training of the data collectors:

Training would consist of both classroom and practical experience. The questionnaire would be

explained in detail to the data collectors and description of how to collect data for each variable

would be formulated in Manual of operations (M.O.O). Practical training would be given during

pretesting of questionnaire. Data collectors would be provided manual and questionnaire prior to

training sessions, in order to explain queries if any. In the training classes data collectors would

be request to practice by conducting interviews of each other. This training would be continued

before, during and after the pretesting.

Pretesting of questionnaire:

All the questionnaires would be pretested in 10% of the overall sample size of the study (22.4 ̴̴

23). Pretesting would be done in an area having participants with the similar characteristic. We

would prefer other diabetic clinics for this purpose in the city. Flow of the questions and

comprehensiveness of the questionnaire would be assessed. Two data collectors would conduct

the questionnaire on the same subject and kappa statistics would be performed to check for the

agreement between the two. Kappa statistics of 0.7 would be taken as acceptable level of

agreement. If agreement of 0.7 is not achieved then the data collectors would be re-trained.

Quality control of Data:

Data collection would be done under the supervision of the principle investigator. Review of

each filled questionnaire would be assured complete and consistent at the end of the interview at

the field site before leaving the study participants. Spot checks of the data collectors would be

done in order to ensure the quality of the data. Observing and supervising the interviews of the

data collectors would be done by the principle investigator throughout the data collection.

Data editing:

The data collected would undergo initial preliminary editing. Further editing would take place

once the questionnaires are back from the field site by the principal investigator. Each question

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would be assessed and edited with a green pen and then a red pen by the principle investigator.

Any missing data would be communicated to the data collectors for rechecking.

Data entry and cleaning:

Two data entry operators would enter the data into a data entry program in parallel. The data

entry program would be designed using Epi-Info. Data entered would be compared for entry

errors and the identified errors would be corrected. 10% of the records would be randomly

chosen from the database and would be compared with the questionnaire data. If there is more

than 0.3% inconsistency between the two entered data, than data entry would be done again by

the entry operators.

Ethical considerations:

Written consent:

Obtaining consent of a potential participant is very important in any study. A written informed

consent would be taken from all the willing participants. Consent form would be both in English

and its Urdu translation. For those who can read only in the national language Urdu, Urdu

translation of the consent form would be made available.

Confidentiality and rights of the participants:

This is the most sensitive part of a study. We would respect our study participant and would

provide all the rights as much as possible. Participants would be informed about the details of the

study in both written form and verbally. The information would be given in clear and simple

language, which would be unambiguous and honest. The purpose of the study, the detail

procedure, what may happen to them and potential risks and benefits would be explained to the

participants. In this study there is no risk of my intervention, both dietary guidelines and text

message but we would inform about everything to them. We would assign identification numbers

to each participant to maintain participant confidentiality. Data would be kept confidential and

no identifiers would be used during the study and also in reports and publications. All the forms

and computer database would be kept secured in the offices under locks and keys and can only

be reached and read by the study personnel. Participants would be informed in detail that

whenever they want they can withdraw from the study, there would be no penalty for that.

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Ethical approval:

We would take the approval for this study from the Ethical Review Committee (ERC) of the Aga

Khan University and Hospital.

Flow chart:All participants with type-II diabetes mellitus

All the participants with type-II diabetes mellitus coming to AKUH center in Karachi

Participants who are diagnosed with type-II diabetes mellitus in the last 3 years to 10 years

Eligibility criteria

Achieved sample of eligible participants

Baseline assessment would be done

Control Group 1. dietary guidelines 2. counseling3. Fortnightly assessment

of dietary compliance through text messaging

Intervention Group1. Dietary guideline,2. Counseling 3. SMS reminder4. Fortnightly assessment of

dietary compliance through text messaging

5.Assessment of outcome

by conducting FFQ (after 3 months)

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References: