Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LT07-115 | Other Identifier | Other |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Madras Diabetes Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | 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. |
|
| Lifestyle Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Intervention | Behavioral | Intervention arm participants will attend 6 months of weekly classes where they will be taught the skills necessary to reach these goals. The curriculum for the classes is based on the DPP lesson plans. Social support will be provided by trained lay health educators and peer support groups. Participants who remain at highest risk of T2DM after four or more months in the program will be prescribed metformin in addition to continuing the lifestyle program. Metformin dosages will start at 500 mg per day, and, when appropriate, will increase to 1000 mg per day (given as 500 mg twice per day). This group will be comprised of individuals who have (1) Fasting plasma glucose values of 100 mg/dl or more and (2) elevated fasting HbA1c measures of 5.7% or more. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Incidence | At baseline and follow-up visit(s), a 75-g oral glucose tolerance test will be administered to measure both 2-hour post-load glucose (2HG) and fasting plasma glucose (FPG). After the intervention and maintenance periods, blood glucose will be measured by a FPG test. Diabetes is diagnosed by a FPG≥126 mg/dL or a 2HG≥200 mg/dL. Diabetes incidence will be calculated by determining the proportion of individuals progressing from pre-diabetes to diabetes at each time point. | Baseline through end of follow-up (mean follow-up time = 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Weight will be measured in kilograms using a standardized, calibrated scale. Weight loss in kilograms and percent weight loss will be calculated. | Baseline through end of follow-up (mean follow-up time = 3 years) |
| Cost-effectiveness |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Viswanathan Mohan, MD, PhD | Madras Diabetes Research Foundation/Dr. Mohan's Diabetes Specialities Centre | Principal Investigator |
| K.M. Venkat Narayan, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madras Diabetes Research Foundation | Chennai | Tamil Nadu | 600 086 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25733342 | Background | 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. | |
| 23596180 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care | Behavioral | Participants randomized to the standard of care group will meet with a physician and a dietician, attend one class/awareness lecture on diabetes prevention through weight loss and diet change and one class on exercise, and receive handouts reinforcing what they learn in class and with the dietician, fitness consultant, and physician. |
|
The cost-effectiveness of the intensive lifestyle program, from the perspectives of a single payer system and society, will be compared with standard lifestyle advice by conducting incremental cost-effective analyses in which the net costs and net effectiveness of the intensive lifestyle program and the standard lifestyle advice is calculated and expressed as a ratio.
| Baseline through end of follow-up (mean follow-up time = 3 years) |
| Waist circumference | Waist circumference in centimeters will be measured using a non-elastic tape measure. Change in waist circumference will be calculated. | Baseline through end of follow-up (mean follow-up time = 3 years) |
| Percent Body Fat | Percent body fat will be measured using bioelectrical impedance (Beurer machine). | Baseline through end of follow-up (mean follow-up time = 3 years) |
| Blood Pressure | Blood Pressure will be measured using standard procedures with an electronic BP apparatus. | Baseline through end of follow-up (mean follow-up time = 3 years) |
| Glycosylated hemoglobin (HbA1c) | HbA1c will be measured from a fasting venous blood sample. | Baseline through end of follow-up (mean follow-up time = 3 years) |
| Plasma Lipids | Plasma levels of high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, and total cholesterol will be measured from fasting venous blood samples. | Baseline through end of follow-up (mean follow-up time = 3 years) |
| Beta Cell Function | Changes in beta cell function [as measured by the Oral Disposition Index, calculated as (ΔI0-30 /ΔG0-30) x (1/fasting insulin)] and insulin resistance (using the Homeostasis Model Assessment of Insulin Resistance, HOMA-IR) will be calculated. | Baseline through end of follow-up (mean follow-up time = 3 years) |
| Dietary Intake | Changes in average diet are assessed by comparing the results of a 12-month food frequency questionnaire (FFQ) from baseline to the end of the intervention period and during follow-up. | aseline through end of follow-up (mean follow-up time = 3 years) |
| Program Acceptability | The acceptability of the intervention will be assessed through focus group discussions with participants who received the lifestyle intervention and phone interviews with program drop-outs. | Baseline through end of follow-up |
| 21616737 | Background | 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. |
| 26321102 | Background | 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. |
| 25458336 | Background | 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. |
| 27504014 | Result | 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. |
| 38607494 | Derived | Pyo E, Weber MB, Sivaram J, Staimez LR, Mohan V, Anjana RM, Haardorfer R, Ranjani H. Construct validity of the 12-item Short Form Health Survey (SF-12) version 2 and the impact of lifestyle modifications on the health-related quality of life among Indian adults with prediabetes: results from the D-CLIP trial. Qual Life Res. 2024 Jun;33(6):1593-1603. doi: 10.1007/s11136-024-03648-6. Epub 2024 Apr 12. |
| 30426214 | Derived | 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. |
| 30397491 | Derived | 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. |
| D004700 | Endocrine System Diseases |