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

March 27, 2024 updated by: Imperial College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1PG
        • Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
>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
4 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

London North West Healthcare NHS Trust

Investigators

  • Principal Investigator: John Chambers, PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimated)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16SM3246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the research is completed the data and results will be made fully anonymous (ie all personal information removed), and available for use by other researchers. Any remaining blood samples will be destroyed.

IPD Sharing Time Frame

2020

IPD Sharing Access Criteria

According to Study Protocol

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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