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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Intensive lifestyle modification

• Registration Number: NCT02949739
• Lead Sponsor: Imperial College London

Brief Summary

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

The specific aims of the proposed iHealth-T2D study are:

1. 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).

2. Investigate secondary endpoints, including health gains in family members. Identify social, demographic and environmental factors influencing primary and secondary endpoints.

3. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5244

Inclusion Criteria

• Waist circumference≥100cm OR HbA1c≥6.0%
• South Asian, Male or Female, and age 40-70 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive lifestyle modification	Intensive lifestyle modification	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.

Primary Outcome Measures

Name	Time	Method
>7% reduction in weight	4 year	The investigators aim to achieve this outcome by motivating study participants to improve diet habits and increase physical activity

Secondary Outcome Measures

Name	Time	Method
Reduction of ≥5 cm waist circumference	4 year	The investigators aim to motivate the participants to adopt a healthier lifestyle in order to achieve at least 5cm waist circumference reduction

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom