Type 2 DiabetesiHealth-T2DNCT02949739
Prevention of Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes
A study testing Intensive lifestyle modification in people with Type 2 Diabetes, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intensive lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,244 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Waist circumference≥100cm OR HbA1c≥6.0%
- South Asian, Male or Female, and age 40-70 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lifestyle Intervention to Prevent 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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Intensive lifestyle modification
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lifestyle modificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
>7% reduction in weight
The investigators aim to achieve this outcome by motivating study participants to improve diet habits and increase physical activity
Measured: 4 year
Secondary outcomes (1)
Reduction of ≥5 cm waist circumference
The investigators aim to motivate the participants to adopt a healthier lifestyle in order to achieve at least 5cm waist circumference reduction
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 5,244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- London North West Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- John Chambers, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949739
- Sponsor's protocol ID
- 16SM3246
- Acronym
- iHealth-T2D
- Status last verified
- Mar 2024
- First submitted
- 27 Apr 2016
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36068618Kasturiratne 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.
PubMed 34922608Muilwijk 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.
PubMed 34725039
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention to Prevent Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes
- ClinicalTrials.gov ID
- NCT02949739
- Acronym / sponsor ID
- iHealth-T2D / 16SM3246
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,244 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- London North West Healthcare NHS Trust
- Study start
- Jan 2015 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive lifestyle modification | Active comparator | Behavioral: Intensive lifestyle modificationThe 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. |
| 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Waist circumference≥100cm OR HbA1c≥6.0%
- South Asian, Male or Female, and age 40-70 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive lifestyle modificationThe 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. | Behavioural | Intensive lifestyle modification |
Primary outcome
>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
1 secondary outcome
Reduction of ≥5 cm waist circumference
Time frame: 4 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 36068618Muilwijk 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.
- Derived from this study: PubMed 34922608Kasturiratne 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.
- Derived from this study: PubMed 34725039Muilwijk 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Chambers, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive lifestyle modification in people with Type 2 Diabetes, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
>7% reduction in weight (time frame: 4 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949739, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.