None listed
Conditions
Brief summary
India has the largest number of individuals with T2DM globally, and this is expected to double by 2030. Thus, the prevention of T2DM, through a combination of individual-, community- and population-based approaches, needs urgent attention. This will be the first implementation trial to target a rural population of India at high risk of developing T2DM by using a validated risk-assessment tool. In this study, we will use an innovative new approach to screening and intervention that first identifies individuals at ‘high risk’ on the basis of a validated diabetes risk questionnaire. This offers a potentially cost-efficient and low burden approach to screening, which will also enable the detection of those at risk. Our study will evaluate a culturally-appropriate group-delivered lifestyle intervention, already demonstrated to be effective in other populations. We will evaluate the effectiveness and cost-effectiveness of this program in a developing country. No additional intervention or measures will be added at 8-year follow-up except for the retinal image measures. Retinal Health--indicating complications of diabetes and CVD. The imaging will assess abnormalities in retina (single measure by type of abnormalities). This will be assessed using retinal imaging camera (this is a composite secondary outcome). No additional intervention or measures will be added at 8-year follow-up except for the retinal image measures. Retinal Health--indicating complications of diabetes and CVD. The imaging will assess abnormalities in retina (single measure by type of abnormalities). This will be assessed using retinal imaging camera (this is a composite secondary outcome).
Interventions
The intervention will involve 2x90 minute diabetes prevention education sessions for participants and their family members/friends and 13x60 minute peer led small group sessions over a 12 month period. Each group will consist of approximately 17 participants and family members and friends will be invited to attend some sessions such as those discussing diet and exercise. Each small group will be led by two peer leaders and supported by a Local Resource Person (well-respected member of community)
The intervention will involve 2x90 minute diabetes prevention education sessions for participants and their family members/friends and 13x60 minute peer led small group sessions over a 12 month period. Each group will consist of approximately 17 participants and family members and friends will be invited to attend some sessions such as those discussing diet and exercise. Each small group will be led by two peer leaders and supported by a Local Resource Person (well-respected member of community). Sessions address three linked themes: 1) how to prevent T2DM and the importance of modest but appreciable lifestyle change to accomplish this; 2) how best to provide emotional/social and environmental support for lifestyle change and a healthy lifestyle; and 3) how to access and link with community resources/supports for change, maintenance and sustainability. Participants are provided with a participant handbook, workbook and health information booklet at the commencement of the intervention. Peer leaders are selected by the groups and attend 2x peer leader training sessions. Peer leader training is conducted over 2 full days at the beginning of the intervention (after session 1 when the peer leaders are selected) and then another two days training after the fifth small group session Peer leaders also communicate following each session (fortnightly for the first four sessions then monthly from session 5) with the K-DPP intervention team to provide feedback on how the session went and obtain suggestions and support if required for future sessions.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Consenting males and females on the electoral roll from the 60 selected polling booths
Exclusion criteria
Prior diagnosis of T2DM or history of other major illnesses; Current use of medication known to affect glucose tolerance; Mental illness; Pregnancy; Illiteracy; Indian Diabetes Risk Score <55; 2 hr plasma glucose of greater than or equal to 11.1 mmol/l; Fasting plasma glucose greater than or equal to 7.0 mmol/l
Outcome results
None listed