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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2022-12-31

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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intensive lifestyle modification

Intervention Type BEHAVIORAL

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.

Usual Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive lifestyle modification

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes