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

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ClinicalTrials.gov Identifier: NCT02949739
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
London North West Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London

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 Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Lifestyle Intervention to Prevent Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes
Study Start Date : January 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949739


Contacts
Contact: John Chambers Chambers, PhD john.chambers@imperial.ac.uk
Contact: Ninha Silva, MSc 020 7594 1530 ninha.silva@imperial.ac.uk

Locations
United Kingdom
Imperial College London Recruiting
London, United Kingdom, W2 1PG
Contact: John Chambers, PhD       john.chambers@imperial.ac.uk   
Contact: Ninha Silva, MSc    020 7594 1530    ninha.silva@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
London North West Healthcare NHS Trust
Investigators
Principal Investigator: John Chambers, PhD Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02949739     History of Changes
Other Study ID Numbers: 16SM3246
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2016
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Obesity, Abdominal
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders