Clinical trial NCT01283308: A Randomized Trial of Diabetes Prevention Through Lifestyle Change in India
Official title: The Diabetes Community Lifestyle Improvement Program (D-CLIP): A Translation Randomized Trial of a Culturally Specific Lifestyle Intervention for Diabetes Prevention in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
India
Prevention & Control
Lifestyle Intervention
Translational Research
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Madras Diabetes Research Foundation
First posted: 2011-01-25
Enrollment: 599
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diabetes Incidence
timeFrame: Baseline through end of follow-up (mean follow-up time = 3 years)
Secondary outcomes:
measure: Body Weight
timeFrame: Baseline through end of follow-up (mean follow-up time = 3 years)
measure: Cost-effectiveness
timeFrame: Baseline through end of follow-up (mean follow-up time = 3 years)
measure: Waist circumference
timeFrame: Baseline through end of follow-up (mean follow-up time = 3 years)
measure: Percent Body Fat
timeFrame: Baseline through end of follow-up (mean follow-up time = 3 years)
measure: Blood Pressure
timeFrame: Baseline through end of follow-up (mean follow-up time = 3 years)
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: Baseline through end of follow-up (mean follow-up time = 3 years)
measure: Plasma Lipids
timeFrame: Baseline through end of follow-up (mean follow-up time = 3 years)
measure: Beta Cell Function
timeFrame: Baseline through end of follow-up (mean follow-up time = 3 years)
measure: Dietary Intake
timeFrame: aseline through end of follow-up (mean follow-up time = 3 years)
measure: Program Acceptability
timeFrame: Baseline through end of follow-up
Other outcomes:
Locations:
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
state: Tamil Nadu
Study officials:
affiliation: Madras Diabetes Research Foundation/Dr. Mohan's Diabetes Specialities Centre
name: Viswanathan Mohan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: K.M. Venkat Narayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weber MB, Ranjani H, Anjana RM, Mohan V, Narayan KM, Gazmararian JA. Behavioral and psychosocial correlates of adiposity and healthy lifestyle in Asian Indians. Prim Care Diabetes. 2015 Dec;9(6):418-25. doi: 10.1016/j.pcd.2015.01.012. Epub 2015 Feb 26.
citation: Staimez LR, Weber MB, Ranjani H, Ali MK, Echouffo-Tcheugui JB, Phillips LS, Mohan V, Narayan KM. Evidence of reduced beta-cell function in Asian Indians with mild dysglycemia. Diabetes Care. 2013 Sep;36(9):2772-8. doi: 10.2337/dc12-2290. Epub 2013 Apr 17.
citation: Weber MB, Ranjani H, Meyers GC, Mohan V, Narayan KM. A model of translational research for diabetes prevention in low and middle-income countries: The Diabetes Community Lifestyle Improvement Program (D-CLIP) trial. Prim Care Diabetes. 2012 Apr;6(1):3-9. doi: 10.1016/j.pcd.2011.04.005. Epub 2011 May 26.
citation: Ranjani H, Weber MB, Anjana RM, Lakshmi N, Narayan KMV, Mohan V. Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting. Diabetes Res Clin Pract. 2015 Oct;110(1):51-59. doi: 10.1016/j.diabres.2015.07.013. Epub 2015 Aug 13.
citation: Anjana RM, Ranjani H, Unnikrishnan R, Weber MB, Mohan V, Narayan KM. Exercise patterns and behaviour in Asian Indians: data from the baseline survey of the Diabetes Community Lifestyle Improvement Program (D-CLIP). Diabetes Res Clin Pract. 2015 Jan;107(1):77-84. doi: 10.1016/j.diabres.2014.09.053. Epub 2014 Oct 7.
citation: Weber MB, Ranjani H, Staimez LR, Anjana RM, Ali MK, Narayan KM, Mohan V. The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial. Diabetes Care. 2016 Oct;39(10):1760-7. doi: 10.2337/dc16-1241. Epub 2016 Aug 8.
citation: Ford CN, Weber MB, Staimez LR, Anjana RM, Lakshmi K, Mohan V, Narayan KMV, Harish R. Dietary changes in a diabetes prevention intervention among people with prediabetes: the Diabetes Community Lifestyle Improvement Program trial. Acta Diabetol. 2019 Feb;56(2):197-209. doi: 10.1007/s00592-018-1249-1. Epub 2018 Nov 13.
citation: Cioffi CE, Ranjani H, Staimez LR, Anjana RM, Mohan V, Weber MB. Self-efficacy and diabetes prevention in overweight South Asians with pre-diabetes. BMJ Open Diabetes Res Care. 2018 Oct 15;6(1):e000561. doi: 10.1136/bmjdrc-2018-000561. eCollection 2018.