Prevention of Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes

Study Overview
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Brief Summary
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The investigators' general goal is to identify approaches to risk stratification and health promotion through lifestyle modification that are acceptable, effective and efficient for prevention of T2D in South Asian communities from diverse settings.

Detailed Description
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The specific aims of the proposed iHealth-T2D study are: Determine whether intensive lifestyle modification vs usual care reduces risk of T2D (primary endpoint) amongst South Asians with i. central obesity; ii. prediabetes and iii. overall (with central obesity and / or obesity). Investigate secondary endpoints, including health gains in family members. Identify social, demographic and environmental factors influencing primary and secondary endpoints. Carry out a health economic analysis of lifestyle modifications vs usual care for prevention of T2D on the Indian subcontinent and Europe. Quantify the cost-effectiveness of screening by waist circumference vs HbA1c.

Official Title
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Lifestyle Intervention to Prevent Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Intensive lifestyle modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Waist circumference≥100cm OR HbA1c≥6.0% South Asian, Male or Female, and age 40-70 years Exclusion Criteria: Known type 1 or 2 diabetes Fasting glucose≥7.0 mmol/L or HbA1c ≥6.5% Normal or underweight (body mass index<22kg/m2) Pregnant or planning pregnancy Unstable residence or planning to leave the area Serious illness Lack of capacity to consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive lifestyle modification<br>The investigators will recruit 3,600 South Asian men and women aged 40-70 years with i. central obesity (waist≥100 cm) and/or ii. prediabetes (HbA1c 6.0-6.4%) to the study (Index cases). Recruitment will be from the Indian subcontinent (India, Pakistan, Sri Lanka) and Europe (UK). Index cases will receive either i. intensive lifestyle modification (N=1,800); or ii. usual care (N=1,800). Intensive lifestyle modification follows clinically accepted, evidence based strategies to achieve >7% reduction in weight through improved diet and increased physical activity, and is delivered as 9 face-face and 13 telephone contact sessions over 12 months. Index cases will be followed for three years to identify new-onset T2D. | Behavioral: Intensive lifestyle modification<br>* The intervention is delivered as 9 face-face and 13 telephone contact sessions over 12 months. Index cases are the focus for the intervention, but lifestyle modification encourages the whole family to adopt healthy living.<br>|
| No Intervention: Usual Care<br>The investigators will recruit 3,600 South Asian men and women aged 40-70 years with i. central obesity (waist≥100 cm) and/or ii. prediabetes (HbA1c 6.0-6.4%) to the study. Recruitment will be from the Indian subcontinent (India, Pakistan, Sri Lanka) and Europe (UK). Index cases will receive either i. intensive lifestyle modification (N=1,800); or ii. usual care (N=1,800). Usual care group will comprise one diabetes prevention session and written material. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| >7% reduction in weight | The investigators aim to achieve this outcome by motivating study participants to improve diet habits and increase physical activity | 4 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of ≥5 cm waist circumference | The investigators aim to motivate the participants to adopt a healthier lifestyle in order to achieve at least 5cm waist circumference reduction | 4 year |