| CTRI Number |
CTRI/2017/08/009198 [Registered on: 01/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
09/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A lifestyle change programme to prevent diabetes in India: the Kerala Diabetes Prevention Program |
|
Scientific Title of Study
|
Kerala Diabetes Prevention Program (K-DPP) |
| Trial Acronym |
K-DPP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ACTRN12611000262909 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof KRThakappan |
| Designation |
Emeritus Professor |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Achutha Menon Centre for Health Science Studies
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
919447072171 |
| Fax |
914712446433 |
| Email |
kavumpurathu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof KRThakappan |
| Designation |
Emeritus Professor |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Achutha Menon Centre for Health Science Studies
Sree Chitra Tirunal Institute for Medical Sciences and Technology
KERALA
695011
India |
| Phone |
919447072171 |
| Fax |
914712446433 |
| Email |
kavumpurathu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof KRThakappan |
| Designation |
Emeritus Professor |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Achutha Menon Centre for Health Science Studies
Sree Chitra Tirunal Institute for Medical Sciences and Technology
KERALA
695011
India |
| Phone |
919447072171 |
| Fax |
914712446433 |
| Email |
kavumpurathu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Health and Medical Research Council, Government of Australia |
|
|
Primary Sponsor
|
| 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.
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Achutha Menon Centre for Health Science Studies |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Anayara Lane, Anayara PO, Trivandrum, Kerala, South India-695011 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof KRThakappan MD MPH FAMS |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Achutha Menon Centre for Health Science Studies
Thiruvananthapuram
KERALA |
919447072171
914712446433
kavumpurathu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Health Sciences Human Ethics Sub-Commiittee at the University of Melbourne |
Approved |
| MonashUniversityHumanEthicsCommittee |
Approved |
| Sree Chitra Tirunal Institutional Ethics Committee, Sree Chitra Tirunal Institute of Medical Sciences and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Type 2 Diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
The 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. |
| Intervention |
The 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 leader 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 session 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. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Consenting males and females of age 30-60 years on the electoral roll from the 60 selected polling booths. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Type 2 Diabetes Incidence (assessed using blood tests and oral glucose tolerance tests to measure fasting plasma glucose and 2 hour post-load glucose). |
12 and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glycosylated haemoglobin (assessed using blood tests) |
12 and 24 months |
| Cholesterol (assessed using blood tests and divided into total, HDL, LDL cholesterol) |
12 and 24 months |
| Triglycerides (assessed using blood tests) |
12 and 24 months |
| Blood pressure (assessed with electronic sphygmomanometers) |
12 and 24 months |
| Obesity (Anthropometric measurements used to obtain Body mass index, Waist circumference and Bio impedance) |
12 and 24 months |
| Diet (using self-reported questionnaire) |
12 and 24 months |
| Physical activity/sedentary behavior (using self-reported questionnaire) |
12 and 24 months |
| Smoking (using self-reported questionnaire) |
12 and 24 months |
| Alcohol Intake (using self-reported questionnaire) |
12 and 24 months |
|
|
Target Sample Size
|
Total Sample Size="1007"
Sample Size from India="1007"
Final Enrollment numbers achieved (Total)= "1007"
Final Enrollment numbers achieved (India)="1007" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2013 |
| Date of Study Completion (India) |
10/01/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="4"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Daivadanam M et al. Lifestyle change in Kerala, India: needs
assessment and planning for a community-based diabetes prevention trial. BMC Public Health 2013; 13: 95.
2. Sathish T et al. Cluster randomised controlled trial of a peerled lifestyle intervention program: study protocol for the Kerala diabetes prevention
program. BMC Public Health 2013; 13: 1035.
3. Sathish et al. Baseline characteristics of participants in the Kerala Diabetes Prevention Program: a cluster randomized controlled trial of lifestyle intervention in Asian Indians. Diabet Med 2017;34:647-653. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 who are at high risk of developing T2DM by using a validated risk-assessment tool. In this study, we will use an innovative new approach to screen 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. |