A Randomized Trial of Diabetes Prevention Through Lifestyle Change in India (D-CLIP)

Emory University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Lifestyle Intervention; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01283308

LT07-115 (Other Identifier)

IRB00016503

Details and patient eligibility

About

People from the Indian subcontinent are more likely to get diabetes, even at younger ages. The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial if a culturally specific, community-based lifestyle and metformin (for individuals who do not respond to lifestyle change alone) intervention for men and women living in Chennai, India can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are programs that seek to prevent disease by promoting changes in health behaviors, improved diet, increased physical activity, and weight loss. The results of this program will be used to make policy and public health recommendations, which will result in broader diabetes prevention efforts. The research team hypothesizes that this program will result in improvements in health (diabetes prevention, weight loss, and improvements in other markers of chronic disease) for intervention participants compared to participants in the control arm of the study.

Full description

Aims: The Diabetes Community Lifestyle Improvement Program (D-CLIP) aims to implement and evaluate in a controlled, randomized trial the effectiveness, cost-effectiveness, and sustainability of a culturally appropriate, low-cost, and sustainable lifestyle intervention for the prevention of type 2 diabetes mellitus in India.

Methods: D-CLIP, a translational research project adapted from the methods and curriculum developed and tested for efficacy in the Diabetes Prevention Program, utilizes innovated methods (a step-wise model of diabetes prevention with lifestyle and metformin added when needed; inclusion of individuals with isolated impaired glucose tolerance, isolated impaired fasting glucose, and both; classes team-taught by professionals and trained community educators) with the goals of increasing diabetes prevention, community acceptability, and long-term dissemination and sustainability of the program. The primary outcome is, diabetes incidence, and secondary outcomes are cost-effectiveness, changes in anthropometric measures, plasma lipids, blood pressure, blood glucose, and HbA1c, and program acceptability and sustainability assessed using a mixed methods approach.

Conclusion: D-CLIP, a low-cost, community-based, research program, addresses the key components of translational research and can be used as a model for prevention of chronic diseases in other low- and middle-income country settings.

Enrollment: 599 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Live in or near Chennai, India
• Aged 20-65 years
• A BMI >22 kg/m2 and/or a waist circumference >90 cm for men and >80 cm for women
• No prior diabetes diagnosis, except for gestational diabetes
• At high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 110 (measured during screening) AND Baseline fasting glucose of 100-125 mg/dL and/or 2-hour post-load glucose of 140-199 mg/dL
• Willingness to consent to randomization

Exclusion criteria

• Does not fulfill inclusion criteria
• Currently pregnant or breastfeeding
• History of or biomarkers indicating heart disease, serious illness, cancer diagnosis in the past 5 years, or other conditions that may impede or prohibit participation in an unsupervised diet change and physical activity program.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

599 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Participants randomized to the standard of care group will receive standard lifestyle advice for diabetes prevention consistent with expert recommendations for a healthy lifestyle, including losing 5-10% of their excess body weight, following standard dietary recommendations to reduce calorie and fat intake, and exercising at least 150 minutes per week.

Treatment:

Behavioral: Standard of Care

Lifestyle Intervention

Experimental group

Description:

Intervention arm participants will participate in a step-wise model of diabetes prevention with the goal of reducing diabetes risk, primarily through (1) a weight loss of at least 7% and (2) 150 minutes or more per week of moderate level physical activity.

Treatment:

Behavioral: Lifestyle Intervention