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 : Active, not recruiting
First Posted : October 31, 2016
Last Update Posted : September 27, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Intensive lifestyle modification||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5244 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- >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
- 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|
- Waist circumference≥100cm OR HbA1c≥6.0%
- South Asian, Male or Female, and age 40-70 years
- 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
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
|Imperial College London|
|London, United Kingdom, W2 1PG|
|Principal Investigator:||John Chambers, PhD||Imperial College London|
|Responsible Party:||Imperial College London|
|Other Study ID Numbers:||
|First Posted:||October 31, 2016 Key Record Dates|
|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.|
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Access Criteria:||According to Study Protocol|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases