A reality TV based diabetes prevention program using mobile phone technology

Completed

• Conditions: Adults above the age of 20 years at risk for Type 2 Diabetes

• Registration Number: CTRI/2015/07/006011
• Lead Sponsor: Biotechnology Industry Research Assistance Council BIRAC

Brief Summary

The proposed study, Mobile Health Technology for the prevention of Type 2 Diabetes (mDiab) is a Randomized Control Trial. It aims to implement and evaluate a Reality TV based lifestyle intervention delivered via a mobile phone application with 1500 people defined as “high risk†randomized to either the reality TV based lifestyle intervention or standard lifestyle counselling at three sites in India namely Chennai, Bengaluru and New Delhi. The research question here is whether lifestyle intervention delivered in the form of a reality based TV show captured as video lessons and delivered via a mobile health (mHealth) application can prevent or delay Type 2 Diabetes in "high risk" population. The “high risk†category in this study is defined as those adults who have one or more of the inclusion criteria. The intervention is in the form of 12 weekly video lessons adapted from the Diabetes Community Lifestyle Improvement Program (D-CLIP), a primary prevention translational trial for diabetes prevention conducted at the MDRF in Chennai, India and to be delivered via android smart phones. The primary outcome will look at a 5% weight loss at 10-12 months. The secondary outcomes will look at improvement in cardio metabolic risk factors (waist circumference, blood pressure, plasma glucose, serum lipids and fasting insulin) and behavioral and social variables at 3-4 months and 10-12 months.

\* IDRS is a simplified validated diabetes risk score devised by Dr V Mohan and Colleagues of the Madras Diabetes Research Foundation. It uses the 4 risk factors, age, physical activity, family history and waist circumference to identify the risk for type 2 diabetes in the Indian population.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-15
• Study Completion: 2018-06-04
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Android Smartphone users between 20 and 65 years of age a) BMI greater than or equal to 25 kg/m2 and/or b) IDRS greater than or equal to 60 and/or c) IDRS greater than or equal to 40 and BMI greater than or equal to 23 kg/m2 and/or d) BMI greater than or equal to 23 kg/m2 and random (110–199 mg/dl) (or) fasting (100 to 125 mg/dl) capillary glucose indicating prediabetes and/or e) IDRS greater than or equal to 40 and random (110 to 199 mg/dl) (or) fasting (100–125 mg/dl) capillary glucose indicating prediabetes.

Exclusion Criteria

Participants involved in other wellness programs, self reported and newly diagnosed diabetes Those who have underone any major surgery (especially cardiovascular or bariatric) within the part three years Pregnancy Type 1 Diabetes Cardiovascular disorders, Advanced stage cancer, kidney failure and or on dialysis Inability to walk and orthopedic disabilities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5% weight loss	10-12 months

Secondary Outcome Measures

Name	Time	Method
Improvement in cardiometabolic risk factors (waist circumference, blood pressure, serum glucose, lipids and insulin) and behavioral and social variables.	3-4 months and 10-12 months

Trial Locations

Locations (3)

Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Chennai; 🇮🇳 Chennai, TAMIL NADU, India

New Delhi; 🇮🇳 South, DELHI, India

Bangalore

🇮🇳Bangalore, KARNATAKA, India

Mr Sidhant Jena

Principal investigator

9871644034

sjena@janacare.com