Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
2 other identifiers
interventional
2,108
1 country
2
Brief Summary
This study will test the implementation, effectiveness, cost-effectiveness, and acceptability of a worksite lifestyle improvement program that includes lifestyle education classes led by trained individuals from the worksite and improvements in the worksite environment that will make it easier for employees at risk for diabetes or with unmedicated diabetes to lose weight, exercise more, and eat a healthier diet. A total of 2000 participants across 10 worksites in South, Central, and East India will be involved in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started May 2017
Longer than P75 for not_applicable diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedStudy Start
First participant enrolled
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2022
CompletedResults Posted
Study results publicly available
September 8, 2023
CompletedSeptember 21, 2023
September 1, 2023
4.7 years
June 17, 2016
June 29, 2023
September 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reaching Two or More Cardiometabolic Risk Goals
The primary outcome assessing program effectiveness is a composite of achieving two or more cardiometabolic risk goals; participants will be scored on the number of risk factors they improve on (0-3) with success delineated by a HbA1c decrease ≥0.5%; a systolic blood pressure decrease ≥5 mm Hg; and a decrease in plasma triglycerides ≥10 mg/dl. Number of participants reaching two or more cardiometabolic Risk Goals will be reported.
Annually up to 2 years
Secondary Outcomes (13)
Blood Pressure (BP)
Baseline, Annually up to 2 years
Mean Hemoglobin A1c (HbA1c) Level
Baseline, annually up to 2 years
Number of New Diabetes Cases
Baseline, end of follow up (up to 2 years post-baseline)
Mean Fasting Plasma Glucose
Baseline, annually up to 2 years
Mean Body Mass Index (BMI)
Baseline, Annually up to 2 years
- +8 more secondary outcomes
Study Arms (1)
Lifestyle Intervention Training Program
EXPERIMENTALParticipants at risk for developing diabetes or with unmedicated diabetes will participate in a lifestyle intervention training program. Individuals in the training program, as well as un-enrolled workers at the study sites, will be exposed to positive changes at the worksite to promote increased physical activity and healthier diets.
Interventions
Participants will be placed into a peer-led classes of 10 to 12 people. The curriculum contains sixteen core sessions that occur weekly for four months followed by an eight month maintenance period. During lifestyle classes, participants will learn strategies for eating a healthy diet, increasing physical activity, overcoming barriers, building social support, reaching and maintaining a healthy wait, and maintaining healthy blood glucose levels. Participants will also be assigned goals to achieve; increasing physical activity and losing 5% of their baseline body weight. During maintenance, participants will receive biweekly SMS text messages providing lifestyle advice tips and encouragement.
Eligibility Criteria
You may qualify if:
- BMI ≥23 kg/m2 and/or waist circumference ≥90 cm for men and ≥80 cm for women
- Prediabetic (HbA1c of 5.7-6.4%) or diabetic (HbA1c≥6.5%)
You may not qualify if:
- Currently taking any diabetes medications
- Pregnant or breastfeeding
- History of heart disease, current serious illness, or conditions which would impede participation in an unsupervised physical activity and diet change program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Public Health Foundation of Indiacollaborator
- Madras Diabetes Research Foundationcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (2)
Madras Diabetes Research Foundation
Chennai, India
Public Health Foundation of India
New Delhi, India
Related Publications (2)
Weber MB, Rhodes EC, Ranjani H, Jeemon P, Ali MK, Hennink MM, Anjana RM, Mohan V, Narayan KMV, Prabhakaran D. Adapting and scaling a proven diabetes prevention program across 11 worksites in India: the INDIA-WORKS trial. Implement Sci Commun. 2023 Nov 13;4(1):134. doi: 10.1186/s43058-023-00516-1.
PMID: 37957783DERIVEDWeber MB, Rhodes EC, Ranjani H, Jeemon P, Ali MK, Hennink MM, Anjana RM, Mohan V, Narayan KV, Prabhakaran D. Adapting and scaling a proven diabetes prevention program across 11 worksites in India: the INDIA-WORKS trial. Res Sq [Preprint]. 2023 Aug 4:rs.3.rs-3143470. doi: 10.21203/rs.3.rs-3143470/v1.
PMID: 37577514DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mary Beth Weber
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Beth Weber, PhD
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 17, 2016
First Posted
June 27, 2016
Study Start
May 2, 2017
Primary Completion
January 15, 2022
Study Completion
January 15, 2022
Last Updated
September 21, 2023
Results First Posted
September 8, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share