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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intensive lifestyle modification
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Imperial College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intensive lifestyle modification

Usual Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 27, 2016
Last Updated
September 20, 2023
Sponsor
Imperial College London
Collaborators
London North West Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02949739
Brief Title
Prevention of Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes
Acronym
iHealth-T2D
Official Title
Lifestyle Intervention to Prevent Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
London North West Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
5244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive lifestyle modification
Arm Type
Active Comparator
Arm 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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive lifestyle modification
Intervention Description
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.
Primary Outcome Measure Information:
Title
>7% reduction in weight
Description
The investigators aim to achieve this outcome by motivating study participants to improve diet habits and increase physical activity
Time Frame
4 year
Secondary Outcome Measure Information:
Title
Reduction of ≥5 cm waist circumference
Description
The investigators aim to motivate the participants to adopt a healthier lifestyle in order to achieve at least 5cm waist circumference reduction
Time Frame
4 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Chambers, PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W2 1PG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
36068618
Citation
Muilwijk M, Loh M, Mahmood S, Palaniswamy S, Siddiqui S, Silva W, Frost GS, Gage HM, Jarvelin MR, Rannan-Eliya RP, Ahmad S, Jha S, Kasturiratne A, Katulanda P, Khawaja KI, Kooner JS, Wickremasinghe AR, van Valkengoed IGM, Chambers JC. The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes-a statistical analysis plan. Trials. 2022 Sep 6;23(1):755. doi: 10.1186/s13063-022-06667-1.
Results Reference
derived
PubMed Identifier
34922608
Citation
Kasturiratne A, Khawaja KI, Ahmad S, Siddiqui S, Shahzad K, Athauda LK, Jayawardena R, Mahmood S, Muilwijk M, Batool T, Burney S, Glover M, Palaniswamy S, Bamunuarachchi V, Panda M, Madawanarachchi S, Rai B, Sattar I, Silva W, Waghdhare S, Jarvelin MR, Rannan-Eliya RP, Gage HM, van Valkengoed IGM, Valabhji J, Frost GS, Loh M, Wickremasinghe AR, Kooner JS, Katulanda P, Jha S, Chambers JC. The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial. Trials. 2021 Dec 18;22(1):928. doi: 10.1186/s13063-021-05803-7.
Results Reference
derived
PubMed Identifier
34725039
Citation
Muilwijk M, Loh M, Siddiqui S, Mahmood S, Palaniswamy S, Shahzad K, Athauda LK, Jayawardena R, Batool T, Burney S, Glover M, Bamunuarachchi V, Panda M, Madawanarachchi M, Rai B, Sattar I, Silva W, Waghdhare S, Jarvelin MR, Rannan-Eliya RP, Wijemunige N, Gage HM, Valabhji J, Frost GS, Wickremasinghe R, Kasturiratne A, Khawaja KI, Ahmad S, van Valkengoed IG, Katulanda P, Jha S, Kooner JS, Chambers JC. Effects of a lifestyle intervention programme after 1 year of follow-up among South Asians at high risk of type 2 diabetes: a cluster randomised controlled trial. BMJ Glob Health. 2021 Nov;6(11):e006479. doi: 10.1136/bmjgh-2021-006479.
Results Reference
derived

Learn more about this trial

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

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