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OpenTrials
Completed

NCT Number: NCT02949739

Prevention of 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London

London, W2 1PG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • London North West Healthcare NHS Trust

Registry information

Official study title

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

Acronym: iHealth-T2D

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2016
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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