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

• ClinicalTrials.gov Identifier: NCT02949739
• Recruitment Status: Active, not recruiting
• First Posted: October 31, 2016
• Last Update Posted: September 27, 2021
• Sponsor: Imperial College London
• Collaborator: London North West Healthcare NHS Trust
• Information provided by (Responsible Party): Imperial College London

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Behavioral: Intensive lifestyle modification	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5244 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Lifestyle Intervention to Prevent Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: October 2018
• Estimated Study Completion Date: July 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. >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 Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United Kingdom

Imperial College London

London, United Kingdom, W2 1PG

Sponsors and Collaborators

Imperial College London

London North West Healthcare NHS Trust

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT02949739
• Other Study ID Numbers: 16SM3246
• First Posted: October 31, 2016
• Last Update Posted: September 27, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: 2020
• Access Criteria: According to Study Protocol

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Obesity, Abdominal; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight