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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]

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

Condition category

Condition code

Metabolic and Endocrine

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]

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]

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]

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]

Change in HbA1c (expected 1%)

Timepoint [1]

Baseline and at the end of follow up (3 months)

Secondary outcome [2]

Change in Fasting blood glucose

Timepoint [2]

Baseline and at the end of follow up (3 months)

Secondary outcome [3]

To assess dietary compliance in participants who will respond to text messages vs. those who will not respond to text messages

Timepoint [3]

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?

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]

Pakistan

State/province [1]

Sind

Funding & Sponsors

Funding source category [1]

University

Name [1]

Aga Khan University

Address [1]

Department of Community Health Sciences, Aga Khan University, Stadium road P.O Box 3500, Karachi- Postal code: 74800, Pakistan

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Review committee Aga Khan University, Pakistan

Ethics committee address [1]

Ethical Review committee, Aga Khan University, Stadium road P.O Box 3500, Karachi- Postal code: 74800,  Pakistan

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

29/07/2011

Approval date [1]

28/11/2011

Ethics approval number [1]

1981-CHS-ERC-11

Summary

Brief summary

We Want to assess whether text messages related to dietary management of diabetes care improve the health (dietary compliance) of patients with type-II diabetes attending Aga Khan hospitals in Karachi Pakistan. We want to assess the difference in dietary compliance in patients with type-II diabetes, who were reminded through text message (SMS) vs. those not reminded. We hypothized 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.

Trial website

Trial related presentations / publications

Nil

Public notes

Contacts

Principal investigator

Name

Mrs Gulshan Bano Ali

Address

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

Australia

Phone

+61-469-542478

Fax

[email protected]

Contact person for public queries

Name

Gulshan Bano Ali

Address

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

Australia

Phone

+61-469-542478

Fax

[email protected]

Contact person for scientific queries

Name

Romaina Iqbal

Address

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

Pakistan

Phone

+923343852055

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial with out participants identifications.

When will data be available (start and end dates)?

I will share data from soon after my manuscript will get published till 10 years.

Available to whom?

Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor

Available for what types of analyses?

Any purpose only to achieve an objective which will benefit the public health research.

How or where can data be obtained?

Data will be shared on contact to PI:
Gulshan Bano Ali:
Email: [email protected]
Alternate Email: [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2415	Study protocol					362518-(Uploaded-21-06-2019-15-03-37)-Study-related document.doc

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			362518-(Uploaded-21-06-2019-14-25-45)-Basic results summary.docx
Plain language summary	No		Summary Results: Motivating patients through text... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically