Prevention of Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes (iHealth-T2D)

Imperial College London

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Intensive lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT02949739

16SM3246

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,244 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,244 participants in 2 patient groups

Intensive lifestyle modification

Active Comparator group

Description:

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.

Treatment:

Behavioral: Intensive lifestyle modification

Usual Care

No Intervention group

Description:

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.