Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000262909
Ethics application status
Approved
Date submitted
9/03/2011
Date registered
10/03/2011
Date last updated
13/05/2022
Date data sharing statement initially provided
13/05/2022
Date results information initially provided
13/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Kerala Diabetes Prevention Program (K-DPP): A cluster RCT trial of its effectiveness and cost-effectiveness
Scientific title
Kerala Diabetes Prevention Program (K-DPP): A cluster RCT trial of its effectiveness and cost-effectiveness
Secondary ID [1] 259692 0
Nil
Universal Trial Number (UTN)
Trial acronym
K-DPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 261266 0
Cardiovascular Disease 326292 0
Condition category
Condition code
Public Health 259418 259418 0 0
Epidemiology
Metabolic and Endocrine 259491 259491 0 0
Diabetes
Cardiovascular 323605 323605 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 264120 0
Prevention
Intervention code [2] 264189 0
Behaviour
Intervention code [3] 264190 0
Lifestyle
Comparator / control treatment
Currently, there is no uniform practice in India for those at high risk of developing T2DM, therefore following baseline assessment, standard care (SC) participants will receive health care advice in the form of a Healthy Living Resource Guide that we have used in similar trials. This guide will comprise culturally appropriate written and pictorial information in Malayalam about a healthy lifestyle and lowering diabetes risk, as well as relevant advice concerning tobacco use, diet, and physical activity in their local community. In addition, SC participants will be advised to inform their health provider of their ‘high risk’ status at the next visit. They will be contacted by letter and/or telephone for follow-up assessments, which will be conducted as per the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 262226 0
Type 2 Diabetes Incidence (assessed using blood tests and oral glucose tolerance tests to measure fasting plasma glucose and 2 hour post-load glucose)
Timepoint [1] 262226 0
the primary timepoint will be baseline, 12 months, 24 months and 8 years.
Primary outcome [2] 331374 0
10-year predicted CVD risk based on Indian Diabetes Risk Score (IDRS)
Timepoint [2] 331374 0
Baseline, 12 months,24 months and 8 years
Secondary outcome [1] 273353 0
Fasting plasma glucose level
Timepoint [1] 273353 0
Baseline, 12 and 24monts, 8 year years post-enrolment.
Secondary outcome [2] 273355 0
Cholesterol (assessed using blood tests and divided into total, HDL, LDL cholesterol)
Timepoint [2] 273355 0
Baseline, 12 and 24monts, 8 year years post-enrolment.
Secondary outcome [3] 273356 0
Triglycerides (assessed using blood tests)
Timepoint [3] 273356 0
Baseline, 12 and 24monts, 8 year years post-enrolment.
Secondary outcome [4] 273357 0
Blood pressure (assessed with electronic sphygmomanometers)
Timepoint [4] 273357 0
Baseline, 12 and 24monts, 8 year years post-enrolment.
Secondary outcome [5] 273491 0
Obesity (Anthropometric measurements used to obtain Body mass index, Waist circumference and Bio-impedance)
Timepoint [5] 273491 0
Baseline, 12 and 24monts, 8 year years post-enrolment.
Secondary outcome [6] 273492 0
Diet (using self-reported questionnaire)
Timepoint [6] 273492 0
Baseline, 12 and 24monts, 8 year years post-enrolment.
Secondary outcome [7] 273493 0
Physical activity/sedentary behaviour (using self-reported questionnaire)
Timepoint [7] 273493 0
Baseline, 12 and 24monts, 8 year years post-enrolment.
Secondary outcome [8] 273494 0
Smoking (using self-reported questionnaire)
Timepoint [8] 273494 0
Baseline, 12 and 24monts, 8 year years post-enrolment.
Secondary outcome [9] 273495 0
Alcohol intake (using self-reported questionnaire)
Timepoint [9] 273495 0
Baseline, 12 and 24monts, 8 year years post-enrolment.
Secondary outcome [10] 409644 0
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)
Timepoint [10] 409644 0
Baseline, 12 and 24monts, 8 year years post-enrolment.

Eligibility
Key inclusion criteria
Consenting males and females on the electoral roll from the 60 selected polling booths
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Neyyatinkara taluk has four legislative assembly constituencies with 603 polling booths. Unfortunately there was no map available that shows the contiguous polling booths across legislative assembly borders. Therefore, polling booths that lay along the border were removed and 60 polling booths from the remaining 359 polling booths were selected. Contiguous polling booths were replaced by the next polling booth to preclude the risk of contamination across polling booth boundaries. The 60 polling booths were be randomly assigned to intervention or control (health information) conditions by a Biostatistician Chief Investigator who will be blinded to all other characteristics of the sampled units. Eligible residents (as determined by the electoral roll) will be invited to participate in-person, by a home screening data collector. Participants that meet the inclusion criteria will be consented and complete the Indian Diabetes Risk Score during a screening interview in their home.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random assignment of the polling booths into intervention or control conditions will be determined by using a constant block size and stratified by size of polling booth using Stata statistical software, Release 12.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A modified simple random sample of 60 polling booths will be selected from the 359 polling booths remaining following excluding the polling booths that lie along legislative assembly borders (approx population/polling booth= 900-1500) located in the Neyyattinkara Taluk (or sub-district) of Kerala State. This is the largest taluk in the Thiruvananthapuram district (area of 571 km squared), with the greatest number of polling booths. To preclude the risk of ‘contamination’ across polling booth boundaries, any clusters of contiguous polling booths in the sample will be replaced and re-sampled. The 60 polling booths will then be randomly assigned to intervention or control (standard care) conditions by a bio-statistician who will be blind to all other characteristics of the sampled units, and by using a constant block size and stratified by size of polling booth, using Stata statistical software package
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
AIM 1: Effectiveness of K-DPP on diabetes and CVD risk at 8 years. The statistical methods to be used at 7 years will be consistent with those already used during the analysis of the data collected at 12 and 24 months. Restricted to the participants greater than or equal to 40 years of age at baseline, a generalised estimating equation model with Poisson link function and robust standard errors to account for clustering at booth level will be fitted to the repeated binary outcome of high CVD risk to estimate the RR reduction of CVD risk greater than or equal to 20% at 7-years in the intervention arm as compared to the control arm, along with a two-sided 95% CI. The model will include treatment, time-point, and treatment by time-point interaction. The sensitivity of the results to assumptions on the missing outcome data underlying this model will be examined using the method of multiple imputation to handle missing data and a pattern-mixture model. Other study outcomes: To evaluate the treatment effect on continuous outcomes (e.g., anthropometrics, blood pressure), a repeated-measures mixed effects regression model accounting for clustering at booth level will be fitted. Any skewed continuous outcome variable may be transformed before fitting this model. The model will include baseline, treatment, time-point, treatment by time-point interaction, and treatment by baseline interaction. The estimated treatment effect (e.g., the absolute difference in means in case of an untransformed outcome) at 7-years and two-sided 95% CI will be obtained. Other binary outcomes (e.g., diabetes) will be analysed using a model similar to that of the primary outcomes, accounting for repeated binary measurements if applicable.

AIM 2: Economic evaluation of K-DPP. Economic evaluation will consist of a cost-effectiveness analysis that will compare the incremental costs and 8-year effects of participants in the K-DPP intervention with participants under the standard care program. Incremental Cost-Effectiveness Ratios (ICER) at the 8-year mark will be calculated by comparing the differences in outcomes between the intervention group and controls with differences in their respective costs, using mixed-linear regression analyses at the participant level with QALYs, diabetes status, indicators of CVD risk and costs as outcomes. The ratio of the estimated effects of the intervention on QALYs to the estimated effects of the intervention on costs will form the key indicator of cost-effectiveness. ICER estimates will be constructed for the full set of participants, as well as for patients with IGT at baseline. Sensitivity analyses will be carried out using different assumptions about the cost of travel and other personal healthcare costs in the population of interest. These analyses will build on ongoing work from the K-DPP study which has estimated that at 24 months, the potential gains from the intervention are as follows. Not accounting for cost offsets from lowered health service use, investing INR 1,374 million on the intervention we have already calculated that K-DPP is likely to avert 144 diabetes cases among individuals identified at risk. ICER estimates will be further constructed for the full set of participants, as well as for patients with IGT at baseline.

AIM 3: Community engagement (CE) and program sustainability. Implementation: A mixed-method analyses using RE-AIM and PIPE Impact Metric to characterize the extent of community engagement and program implementation from program provider and program participant perspectives. This will include basic quantitative analysis of answers from a standardized questionnaire on individual participation-to ascertain participant perceptions on the interventions impact and quality. Qualitative analyses from the structured interviews will follow standard methods of verbatim transcripts and field notes, iterative coding and inter-coder agreement to determine overall themes. Impact of Implementation: With appropriate consideration of unit-of-analysis and non-independent observations within communities, statistical analyses will characterize the relationships among overall CE and elements of CE and program implementation, individual, family, and community-level outcomes, and patterns of maintenance of outcomes over time. Value/Feasibility/Sustainability: Qualitative analysis will identify the perceived value, barriers and advantages of the K-DPP model to individuals, families, and communities to determine the potential feasibility and sustainability of the program. These latter observations will guide further adaptation of the K-DPP model for scale up to other states of India and other LMICs.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
26/01/2013
Date of last participant enrolment
Anticipated
3/11/2013
Actual
10/11/2013
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
1020
Accrual to date
Final
1007
Recruitment outside Australia
Country [1] 3241 0
India
State/province [1] 3241 0
Kerala

Funding & Sponsors
Funding source category [1] 264622 0
Government body
Name [1] 264622 0
National Health and Medical Research Council
Country [1] 264622 0
Australia
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Baker Heart and Diabetes Institute
75 Commercial Road, Melbourne 3004, VIC
Country
Australia
Secondary sponsor category [1] 263760 0
University
Name [1] 263760 0
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Address [1] 263760 0
Achutha Menon Centre for Health Science Studies,
Sree Chitra Tirunal Institute for Medical Science and Technology,
Anayara Lane, Anayara P.O.
Trivandrum, Kerala, South India
Country [1] 263760 0
India
Other collaborator category [1] 251854 0
University
Name [1] 251854 0
University of North Carolina-Chapel Hill
Address [1] 251854 0
Gillings School of Global Public Health,
University of North Carolina at Chapel Hill,
Campus Box 7440,
Chapel Hill,
North Carolina 27599-7440
Country [1] 251854 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266626 0
Monash University Human Ethics Committee
Ethics committee address [1] 266626 0
Human Ethics Office
First Floor, Building 3e
Monash Research Office
Clayton Campus
Monash University
VIC 3800
Ethics committee country [1] 266626 0
Australia
Date submitted for ethics approval [1] 266626 0
21/02/2011
Approval date [1] 266626 0
23/05/2011
Ethics approval number [1] 266626 0
2011000194
Ethics committee name [2] 266627 0
Sree Chitra Tirunal Institutional Ethics Committee
Ethics committee address [2] 266627 0
Sree Chitra Tirunal Institute of Medical Sciences and Technology,
Thiruvananthapuram, Kerala
Ethics committee country [2] 266627 0
India
Date submitted for ethics approval [2] 266627 0
06/05/2011
Approval date [2] 266627 0
23/07/2013
Ethics approval number [2] 266627 0
SCT/IEC-333/May-2011
Ethics committee name [3] 293720 0
Health Sciences Human Ethics Sub-Committee at the University of Melbourne
Ethics committee address [3] 293720 0
Level 1
780 Elizabeth Street
Parkville
VIC 3052
Ethics committee country [3] 293720 0
Australia
Date submitted for ethics approval [3] 293720 0
Approval date [3] 293720 0
14/10/2014
Ethics approval number [3] 293720 0
1441736
Ethics committee name [4] 310908 0
Alfred HREC
Ethics committee address [4] 310908 0
The Alfred
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [4] 310908 0
Australia
Date submitted for ethics approval [4] 310908 0
23/09/2021
Approval date [4] 310908 0
27/09/2021
Ethics approval number [4] 310908 0
463/21
Ethics committee name [5] 310909 0
Sree Chitra Tirunal Institutional Ethics Committee
Ethics committee address [5] 310909 0
Sree Chitra Tirunal Institute of Medical Sciences and Technology, Thiruvananthapuram, Kerala, 695011
Ethics committee country [5] 310909 0
India
Date submitted for ethics approval [5] 310909 0
12/04/2019
Approval date [5] 310909 0
07/05/2019
Ethics approval number [5] 310909 0
SCT/IEC/1349/APRIL-2019

Summary
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).
Trial website
Trial related presentations / publications
Sathish et al. Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala Diabetes Prevention Program. BMC Public Health 2013, 13:1035
Public notes

Contacts
Principal investigator
Name 32281 0
Prof Brian Oldenburg
Address 32281 0
Baker Heart and Diabetes Institute
75 Commercial Rd, Melbourne VIC 3004
Country 32281 0
Australia
Phone 32281 0
+61419025692
Fax 32281 0
Email 32281 0
brian.oldenburg2@baker.edu.au
Contact person for public queries
Name 15528 0
Dr Tilahun Haregu
Address 15528 0
Baker Heart and Diabetes Institute
75 Commercial Rd, Melbourne VIC 3004
Country 15528 0
Australia
Phone 15528 0
+61413661418
Fax 15528 0
Email 15528 0
haregu.t@unimelb.edu.au
Contact person for scientific queries
Name 6456 0
Prof Brian Oldenburg
Address 6456 0
Baker Heart and Diabetes Institute
75 Commercial Rd, Melbourne VIC 3004
Country 6456 0
Australia
Phone 6456 0
+61419025692
Fax 6456 0
Email 6456 0
brian.oldenburg2@baker.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Daivadanam M, Absetz P, Sathish T, Thankappan KR, ... [More Details]
Study results articleYes Sathish T, Williams ED, Pasricha N, Absetz P, Lorg... [More Details]
Study results articleYes Aziz Z, Absetz P, Oldroyd J, Pronk NP, Oldenburg B... [More Details]
Study results articleYes Sathish T, Oldenburg B, Tapp RJ, Shaw JE, Wolfe R,... [More Details]
Study results articleYes Mathews E, Thomas E, Absetz P, D'Esposito F, Aziz ... [More Details]
Study results articleYes Sathish T, Aziz Z, Absetz P, Thankappan KR, Tapp R... [More Details]
Study results articleYes Sathish T, Shaw J, Tapp RJ, Wolfe R, Thankappan KR... [More Details]
Study results articleYes Thankappan KR, Sathish T, Tapp RJ, Shaw JE, Lotfal... [More Details]
Study results articleYes Aziz Z, Mathews E, Absetz P, Sathish T, Oldroyd J,... [More Details]
Study results articleYes Sathish T, Oldenburg B, Thankappan KR, Absetz P, S... [More Details]
Study results articleYes Kapoor N, Lotfaliany M, Sathish T, Thankappan KR, ... [More Details]
Study results articleYes Kapoor N, Lotfaliany M, Sathish T, Thankappan KR, ... [More Details]
Study results articleYes Lotfaliany M, Sathish T, Shaw J, Thomas E, Tapp RJ... [More Details]
Study results articleYes Ranjana Ravindranath, Brian Oldenburg, Sajitha Bal... [More Details]
Study results articleYes Campbell, M.D., Sathish, T., Zimmet, P.Z. et al. B... [More Details]
Study results articleYes Tilahun Nigatu Haregu, PhD, Kishori Mahat, MBBS, M... [More Details]
Study results articleYes De Man J, Absetz P, Sathish T, et al. Are the PHQ-... [More Details]
Study results articleYes Johnson LCM, Desloge A, Sathish T, Williams ED, Ab... [More Details]
Study results articleYes Nitin Kapoor, Mojtaba Lotfaliany, Thirunavukkarasu... [More Details]
Study results articleYes Lotfaliany M, Sathish T, Shaw J, Thomas E, Tapp RJ... [More Details]
Study results articleYes Sathish, T., Oldenburg, B., Thankappan, K.R. et al... [More Details]
Study results articleYes Haregu, T.N., Byrnes, A., Singh, K. et al. A scopi... [More Details]
Study results articleYes Byrnes A, Haregu TN, Pasricha N, et al. Strengthen... [More Details]
Study results articleYes Aziz, Z., Riddell, M.A., Absetz, P. et al. Peer su... [More Details]
Study results articleYes Hone P, Black J, Sathish T, Kapoor N, Cao Y, Hareg... [More Details]
Study results articleYes Cao Y, Sathish T, Haregu T, Wen Y, de Mello GT, Ka... [More Details]
Study results articleYes Cao, Yingting, and Huynh, Quan, et al. "Associatio... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCultural adaptation of a peer-led lifestyle intervention program for diabetes prevention in India: the Kerala diabetes prevention program (K-DPP).2018https://dx.doi.org/10.1186/s12889-017-4986-0
EmbaseA group-based lifestyle intervention for diabetes prevention in low- and middle-income country: implementation evaluation of the Kerala Diabetes Prevention Program.2018https://dx.doi.org/10.1186/s13012-018-0791-0
EmbaseEffects of a lifestyle intervention on cardiovascular risk among high-risk individuals for diabetes in a low- and middle-income setting: Secondary analysis of the Kerala Diabetes Prevention Program.2020https://dx.doi.org/10.1016/j.ypmed.2020.106068
EmbaseEffect of a Peer-led Lifestyle Intervention on Individuals With Normal Weight Obesity: Insights From the Kerala Diabetes Prevention Program.2020https://dx.doi.org/10.1016/j.clinthera.2020.06.007
EmbaseObesity indicators that best predict type 2 diabetes in an Indian population: Insights from the Kerala Diabetes Prevention Program.2020https://dx.doi.org/10.1017/jns.2020.8
N.B. These documents automatically identified may not have been verified by the study sponsor.