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

NCT02949739 | Completed DMC

• 1 other identifier: 16SM3246
• Study Type: interventional
• Target: 5,244
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• >7% reduction in weight

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

  4 year

Secondary Outcomes (1)

• Reduction of ≥5 cm waist circumference

  4 year

Study Arms (2)

Intensive lifestyle modification

ACTIVE COMPARATOR

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

Usual Care

NO INTERVENTION

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.

Interventions

Intensive lifestyle modification 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.

Intensive lifestyle modification

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Waist circumference≥100cm OR HbA1c≥6.0%
• South Asian, Male or Female, and age 40-70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• London North West Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial College London

London, W2 1PG, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 36068618 DERIVED

• 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.

  PMID: 34922608 DERIVED

• 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.

  PMID: 34725039 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• John Chambers, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: October 31, 2016
• Study Start: January 1, 2015
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 2020
• Access Criteria: According to Study Protocol

Locations

GB (1)