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Clinical Trials/NCT02949739
NCT02949739
Completed
Not Applicable

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

Imperial College London1 site in 1 country5,244 target enrollmentJanuary 2015
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Imperial College London
Enrollment
5244
Locations
1
Primary Endpoint
>7% reduction in weight
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

>7% reduction in weight

Time Frame: 4 year

The investigators aim to achieve this outcome by motivating study participants to improve diet habits and increase physical activity

Secondary Outcomes

  • Reduction of ≥5 cm waist circumference(4 year)

Study Sites (1)

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