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Trial registered on ANZCTR


Registration number
ACTRN12612000538842
Ethics application status
Approved
Date submitted
18/05/2012
Date registered
21/05/2012
Date last updated
25/06/2019
Date data sharing statement initially provided
25/06/2019
Date results provided
25/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of Dietary compliance in Type-2 diabetes mellitus patients by sending text message reminders
Scientific title
Assessment of Dietary Compliance among Patients with Type II Diabetes Mellitus Receiving Text Message (SMS) Reminders for improving adherence to healthy diet in Pakistan: A Randomized Control Trial
Secondary ID [1] 280513 0
Nil
Universal Trial Number (UTN)
U1111-1130-8095
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type-II Diabetes Mellitus 286502 0
Condition category
Condition code
Metabolic and Endocrine 286762 286762 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mobile Text Message Reminders:Contant of these text message reminders are gereral dietary tips, we developed these text message reminders using "American Dietetic Association Complete Food and Nutrition Guide"

Cereal, starch and whole grain foods:

1.Eat plenty of cereals (preferably whole grain), including breads, pasta and rice.
2.To eat more whole grains, use a whole-grain product instead of a refined product - such as eating whole-wheat bread instead of white bread.
3.Cooked oatmeal is an inexpensive, healthy cereal, which lowers cholesterol also.
4.Do not use white rice, instead use brown rice.
5.Do not eat fried food e.g. French fries, fried rice and biryani. Prefer baked products.

Vegetable:

1.Choose most of your foods from vegetables. These foods are loaded with nutrition, providing vitamins, and minerals
2.Keep a bowl of cut-up all kinds of vegetables on the top shelf of your refrigerator. So you will have frequently in your diet.
3.Start every meal with a salad: a mix of dark green varieties of lettuce and colorful vegetables.
4.Do not use fried vegetables. Use a nonstick frying pain to avoid oil.
5.Do not cook vegetable for a long period of time, than it will lose its nutrient.

Fruits:

1.Include fresh, low sugar fruits in your diet e.g. apple, apricot, lemon, papaya, plum etc.
2.Do not eat more than one fruit at a time but you can include a variety over the whole day.
3.Try to eat fruits with skin. Do not peel the skin of apple, apricot, pear, peach and plums etc.
4.Eat small amount of grapes, mango and persimmon, overeating of these foods is non-beneficial.
5.Do not put fruits in refrigerator for long, try to eat fresh fruits.

Nuts and legume:

1.Nuts are laden with fat, but the type of fat is good for our heart, (most nuts do not contain saturated fat, coconut is an exception).
2.To keep your heart and blood vessels healthy, choose plant foods, such as include nuts, legumes and olives in cooking.
3.Some legumes are beings used to improve diabetics' blood glucose control i.e. Soya beans, fava beans, guar ki phalli and same etc.
4.Daal eaten with roti or rice provides good quality protein to an individual.
5.Do not overcook beans, because they will lose the important nutrients.

Fish, poultry and eggs:

1.Choose fish and skinless poultry for your diet.
2.Limit the number of eggs you eat to 2-3 per week.
3.Fish, poultry and eggs are all good sources of high-quality protein
4.Seafood (fish) is a good source of food containing healthy contents, so consume fish 1/week at least.
5.Prepare fish baked, broiled, grilled or boiled rather than breaded and fried.

Dairy products:

1.Select low-fat or fat-free milk e.g. skim milk.
2.Choose low-fat and fat-free yogurt, artificially sweetened or unsweetened.
3.Many dairy products, like no sugar added, fat-free yogurt, can be eaten as a dessert
4.Do not eat butter daily in your routine.
5.Do not eat food containing high quantity of cheese like pizza's and cheese burgers.

Meat products:

1.Meat and meat products: Eat sparingly, once in a week or even less than that.
2.Meat is good sources of high-quality protein, but they also come with high fats, so be careful.
3.Buy lean cuts of meat.
4.There are several ways you can reduce the fat in meat: Broil, grill, steam or roast instead of frying.
5.Chill meat broth and drippings so the fat rises and solidifies. Then it can be skimmed off the top before serving or making gravy.

Sweets and drinks:

1.Sweets and cold drinks: Eat small amounts of these foods, once or less times in a week.
2.Artificial sweeteners give you the sweet taste of sugar without its calories. One packet gives the same sweetness as two teaspoons of table sugar.
3.Volunteer to bring your favorite low-sugar dessert to social functions
4.Always check every label if in any doubt about a food or drink.
5.Try to use diet drinks rather better to avoid at all.

Discription:
we will send 3 different messages per week for three months (12 week).

A pamphlet of general dietary guidelines will be given to the patient while conducting baseline interview in the clinic face to face. And a breif counseling will be given.
Intervention code [1] 284887 0
Lifestyle
Comparator / control treatment
Control:

A pamphlet of general dietary guideline will be provided with a breif counseling face to face in the baseline interview.
Control group
Active

Outcomes
Primary outcome [1] 287149 0
Compliance to dietary guidelines scores would be the Primary outcome , which would be measured by using the food frequency questionnaire (FFQ). FFQ would be conducted at the baseline as well as after the intervention period (3 months of follow up). We would expect a difference of 1.5 score of dietary compliance between the two groups
Timepoint [1] 287149 0
We will conduct the food frequency questionnaire at the baseline, midway (one and half month) for the interim analysis and at the end of follow up period (three months)
Secondary outcome [1] 297498 0
Change in HbA1c (expected 1%)
Timepoint [1] 297498 0
Baseline and at the end of follow up (3 months)
Secondary outcome [2] 297514 0
Change in Fasting blood glucose
Timepoint [2] 297514 0
Baseline and at the end of follow up (3 months)
Secondary outcome [3] 297515 0
To assess dietary compliance in participants who will respond to text messages vs. those who will not respond to text messages
Timepoint [3] 297515 0
A fortnightly message will be send to both the groups. The contant of this message will be: Q1: About fruits In the last 24hrs did you have any fruits? Write: 1 (if yes) than enter the number of fruits. Write: 2 (if no) Q2: About vegetables: In the last 24hrs did you have any vegetables? Write: 1 (if yes) than enter the number of vegetables. Write: 2 (if no) There will be 6 messages for each participant for which they have to respond.

Eligibility
Key inclusion criteria
1. Patients of age between 30 to 70 years
2. Patients with an HbA1c more than 7
3. Cases diagnosed with type-II diabetes since 2 to 15 years
4. Those patients who have mobile phone and do not intend to change their phone number in the next six months
5. Those who can read the SMS written in Urdu and will be able to respond to it
6. Those who are on oral hypoglycemic medication only
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Serious chronic co-morbidities e.g. Diabetic ketosis, Severe Diabetic foot, Nephropathy, Neuropathy, Retinopathy (taking injectable hypoglycemic drugs), chronic Renal failure, Liver cirrhosis
2. Those who cannot give consent
3. Not able to understand Urdu
4. Enrolled in any other study
5. Pregnant females
6. Hearing and verbal disabilities

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. We will enroll a subject from Aga Khan Hospital 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.
2. Sealed Opaque envolopes will be used. A third person will randomly pic the envolop to allocate the subject.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use block randomization. We made all the possible combinations for these two blocks. We assign A for intervention and B for control group. We made the envelops of only two combination for block 2, i.e. AB and BA while for block 4 we made 6 possible combinations like AABB, ABAB, BABA, BBAA, ABBA, BAAB. A third person is picking any one of the envelop to assign the participant for any of the group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2012
Actual
21/06/2012
Date of last participant enrolment
Anticipated
Actual
11/03/2015
Date of last data collection
Anticipated
Actual
12/06/2015
Sample size
Target
248
Accrual to date
Final
249
Recruitment outside Australia
Country [1] 4323 0
Pakistan
State/province [1] 4323 0
Sind

Funding & Sponsors
Funding source category [1] 285278 0
University
Name [1] 285278 0
Aga Khan University
Country [1] 285278 0
Pakistan
Primary sponsor type
University
Name
Aga Khan University
Address
Department of Community Health Sciences, Aga Khan University, Stadium road P.O Box 3500, Karachi- Postal code: 74800, Pakistan
Country
Pakistan
Secondary sponsor category [1] 284138 0
None
Name [1] 284138 0
Address [1] 284138 0
Country [1] 284138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287291 0
Ethical Review committee Aga Khan University, Pakistan
Ethics committee address [1] 287291 0
Ethics committee country [1] 287291 0
Pakistan
Date submitted for ethics approval [1] 287291 0
29/07/2011
Approval date [1] 287291 0
28/11/2011
Ethics approval number [1] 287291 0
1981-CHS-ERC-11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34196 0
Mrs Gulshan Bano Ali
Address 34196 0
Melbourne School of Population and Global Health, Center for Epidemiology and Bio-statistics, Allergy and Lung Health Unit. 207 Bouverie St, Carlton VIC 3053
Country 34196 0
Australia
Phone 34196 0
+61-469-542478
Fax 34196 0
Email 34196 0
[email protected]
Contact person for public queries
Name 17443 0
Gulshan Bano Ali
Address 17443 0
Melbourne School of Population and Global Health, Center for Epidemiology and Bio-statistics, Allergy and Lung Health Unit. 207 Bouverie St, Carlton VIC 3053
Country 17443 0
Australia
Phone 17443 0
+61-469-542478
Fax 17443 0
Email 17443 0
[email protected]
Contact person for scientific queries
Name 8371 0
Romaina Iqbal
Address 8371 0
Romaina Iqbal MSc, MPH, PhD Assistant Professor Departments of Community Health Sciences and Medicine Aga Khan University, Stadium road P.O Box 3500, Karachi- Postal code: 74800, Pakistan
Country 8371 0
Pakistan
Phone 8371 0
+923343852055
Fax 8371 0
Email 8371 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trial with out participants identifications.

What types of analyses could be done with individual participant data?
• Any purpose only to achieve an objective which will benefit the public health research.

When can requests for individual participant data be made (start and end dates)?
From:
I will share data from soon after my manuscript will get published till 10 years.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data will be shared on contact to PI:
Gulshan Bano Ali:
Email: [email protected]
Alternate Email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2415Study protocol    Study-related document.doc



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo Basic results summary.docx
Plain language summaryNo Summary Results: Motivating patients through text... [More Details]

Documents added automatically
No additional documents have been identified.