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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02949739
Acronym
iHealth-T2D
Enrollment
5244
Registered
2016-10-31
Start date
2015-01-31
Completion date
2022-12-31
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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: 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.

Interventions

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.

Sponsors

London North West Healthcare NHS Trust
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
>7% reduction in weight4 yearThe investigators aim to achieve this outcome by motivating study participants to improve diet habits and increase physical activity

Secondary

MeasureTime frameDescription
Reduction of ≥5 cm waist circumference4 yearThe investigators aim to motivate the participants to adopt a healthier lifestyle in order to achieve at least 5cm waist circumference reduction

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026