mDiab

mDiab

A new kind of app that helps you prevent Type 2 Diabetes

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About the study

mDiab is a Randomized Control Trial that aims to implement and evaluate a Reality TV based lifestyle intervention in India delivered via a mobile phone application using a randomized control trial.

Funded by Department of Biotechnology (DBT) under their scheme entitled Biotechnology Industry Partnership Programme (BIPP)

Who is Eligible to Participate?

Inclusion criteria:
  1. Age above 20 years
  2. Must own a smart phone with internet connection
  3. BMI >= 25 kg/m2
  4. IDRS >= 60
  5. Prediabetes
Exclusion criteria:
  1. Participants involved in other wellness programs, self-reported and newly diagnosed diabetes
  2. Those who have undergone any major surgery (esp. cardiovascular or bariatric) within past 3 years
  3. Pregnancy
  4. Type 1 diabetes
  5. Cardiovascular (CVD) disorders (unstable angina pectoris, heart failure, lifethreatening arrhythmia), Advanced stage cancer, kidney failure and/or on dialysis)

How this study works

The following are the different components of the study

Screening

Participants will be identified through community based screening camps.

Screening procedure will include the following

  • A short questionnaire about the participant‟s health
  • Using the above data IDRS will be calculated to estimate their risk for diabetes
  • Apart from these, a small amount of blood will be taken from the participant's finger to measure capillary blood glucose

If the participant has an IDRS >= 60 and/or BMI >= 25 and/or Fasting Capillary Blood Glucose (FCBG) 100-125mg/dl or Random Capillary Blood Glucose (RCBG) 110-199mg/dl then he/she will be invited for the next round of confirmatory tests.

Baseline

Participants eligible at screening will be invited to the baseline testing. The participants should not have eaten or drunk anything, except water for at least 10-12 hours prior to arriving at the test centre. This visit will include the following,

  • Questionnaires about the participants health habits, diet, Quality Of Life(QOL) and physical activity/inactivity
  • Weight, height, waist circumference, body fat percent and blood pressure measurement
  • Blood will be drawn to measure the following: Two sample oral Glucose Tolerance Test (OGTT), Fasting Insulin Assay (FIA), Glycated hemoglobin (HbA1c) and lipid profile

Randomization

The participants will then be randomized to either receive standard care treatment or the mobile health intervention.

Control Group

The participants randomized into control group will receive a standard care kit which will contain brochures on healthy lifestyle. They will be offered a consultation with a physician based on their blood values.

Intervention Group

The intervention is a reality TV based prevention program administered through a mobile health application "mDiab". The content of the reality TV based prevention program is adapted from the D-CLIP curriculum which has been developed into 12 weeks of video lessons.

Post Intervention

Both the study groups (control and intervention) will be called for post intervention testing after 3-4 months (12-16 weeks) of intervention period. This visit will include the following,

  1. Questionnaires about the participants health habits, diet and physical activity
  2. Height, weight and waist circumference measurement, percent body fat and blood pressure measurement
  3. Fasting Insulin Assay, Glycated hemoglobin (HbA1c) and lipid profile

One Year Follow Up Testing

Both the study groups (control and intervention) will be called for a follow up testing 1 year post baseline. This is a timeline of 6-7 months (24 - 28 weeks) after the post intervention testing. During this phase, the intervention group will not receive any form of mHealth support from the research team although, the videos and messages and chats will always be available to them to revisit. This visit will include the following,

  1. Questionnaires about the participants health habits, diet and physical activity
  2. Height, weight and waist circumference measurement, percent body fat and blood pressure measurement
  3. Two sample OGTT, Fasting Insulin Assay, Glycated hemoglobin (HbA1c) and lipid profile

Focus Group Discussions (FGDs) will be conducted during the follow up period. Two at each site (men and women separately) consisting of at least 8-10 participants in each FGD. This way we will plan to have a total 6 FGDs consisting of 50-60 participants.

Who is running the study?

  • Janacare Solutions Private Limited, Bengaluru
  • Dr. V. Mohan, Dr. Mohan's Diabetes Specialities Centre (DMDSC) and Madras Diabetes Research Foundation (MDRF), Chennai
  • Dr. Nikhil Tandon, All India Institute of Medical Sciences (AIIMS), New Delhi
  • Dr. RM Anjana, DMDSC and MDRF
  • Dr. Ranjani Harish, DMDSC and MDRF

Funded by Department of Biotechnology (DBT) under their scheme entitled Biotechnology Industry Partnership Programme (BIPP)