CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,108 enrolled
Drug / intervention
Lifestyle Intervention Training Programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02813668
NCT02813668N/ACompleted

Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

Emory University·interventional·Posted Jun 27, 2016·Updated Sep 21, 2023

In Brief

A clinical study evaluating Lifestyle Intervention Training Program for Diabetes and 2 related conditions. Completed, enrolled 2,108 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 27, 2016
Enrollment StartMay 2, 2017
Primary CompletionJan 15, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.0 years ago

Interventions

Lifestyle Intervention Training Programbehavioral

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.