The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12611000262909
Ethics application status
Approved
Date submitted
9/03/2011
Date registered
10/03/2011
Date last updated
20/10/2015
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
Condition category
Condition code
Public Health 259418 259418 0 0
Epidemiology
Metabolic and Endocrine 259491 259491 0 0
Diabetes

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
12 and 24 months
Secondary outcome [1] 273353 0
Glycosylated haemoglobin (assessed using blood tests)
Timepoint [1] 273353 0
12 and 24 months
Secondary outcome [2] 273355 0
Cholesterol (assessed using blood tests and divided into total, HDL, LDL cholesterol)
Timepoint [2] 273355 0
12 and 24 months
Secondary outcome [3] 273356 0
Triglycerides (assessed using blood tests)
Timepoint [3] 273356 0
12 and 24 months
Secondary outcome [4] 273357 0
Blood pressure (assessed with electronic sphygmomanometers)
Timepoint [4] 273357 0
12 and 24 months
Secondary outcome [5] 273491 0
Obesity (Anthropometric measurements used to obtain Body mass index, Waist circumference and Bio-impedance)
Timepoint [5] 273491 0
12 and 24 months
Secondary outcome [6] 273492 0
Diet (using self-reported questionnaire)
Timepoint [6] 273492 0
12 and 24 months
Secondary outcome [7] 273493 0
Physical activity/sedentary behaviour (using self-reported questionnaire)
Timepoint [7] 273493 0
12 and 24 months
Secondary outcome [8] 273494 0
Smoking (using self-reported questionnaire)
Timepoint [8] 273494 0
12 and 24 months
Secondary outcome [9] 273495 0
Alcohol intake (using self-reported questionnaire)
Timepoint [9] 273495 0
12 and 24 months

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
Gender
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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 264622 0
GPO Box 1421
Canberra ACT 2601
Country [1] 264622 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Non-Communicable Disease Unit
Melbourne School of Population and Global Health
207 Bouverie Street
The University of Melbourne 3010
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

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.
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
Non-Communicable Disease Unit
Melbourne School of Population and Global Health
207 Bouverie Street
The University of Melbourne 3010
Country 32281 0
Australia
Phone 32281 0
+613 8344 0453
Fax 32281 0
Email 32281 0
brian.oldenburg@unimelb.edu.au
Contact person for public queries
Name 15528 0
Dr Fabrizio D'Esposito
Address 15528 0
Non-Communicable Disease Unit
Melbourne School of Population and Global Health
207 Bouverie Street
The University of Melbourne 3010
Country 15528 0
Australia
Phone 15528 0
+613 8344 3108
Fax 15528 0
Email 15528 0
fabrizio.desposito@unimelb.edu.au
Contact person for scientific queries
Name 6456 0
Prof Brian Oldenburg
Address 6456 0
Non-Communicable Disease Unit
Melbourne School of Population and Global Health
207 Bouverie Street
The University of Melbourne 3010
Country 6456 0
Australia
Phone 6456 0
+613 8344 0453
Fax 6456 0
Email 6456 0
brian.oldenburg@unimelb.edu.au