Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
- Registration Number
- NCT03258723
- Lead Sponsor
- Yale University
- Brief Summary
Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.
Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle intervention, with escalation to Metformin therapy will lower the incidence of diabetes among the highest risk pre-diabetic individuals of Caribbean-descent.
- Detailed Description
The investigators propose to conduct a pragmatic trial that tests the effectiveness of lifestyle modification and Metformin use in minority populations. Our study population is Caribbean-descent individuals in Region 2, Trinidad and Barbados. The investigators will have five clinical intervention sites situated in New York - 2, Puerto Rico -1, Barbados -1, Trinidad -1 and US Virgin Islands -1. These sites were chosen because of the investigators' strong research network in these locations, and to enable us to address diabetes disparities due to geographic differences. The investigators will first modify an established lifestyle modification workshop series developed by the East Harlem Partnership for Diabetes Prevention (EHPDP) for use in the community, 10to target the population at the involved clinical sites. The investigators plan to adapt the D-CLIP protocol and escalate to Metformin therapy for the highest risk pre-diabetic patients whose hemoglobin A1c (HbA1c) has not improved or who remain morbidly obese.
The investigators will leverage our existing robust research infrastructure and network at the five sites through our Eastern Caribbean Health Outcomes Research Network (ECHORN) and now the Yale Transdisciplinary Collaborative center for Health Disparities focused on Precision Medicine (Yale-TCC). ECHORN is a research collaboration funded by the NIMHD (U2458849938) to address the burden of chronic disease in USVI, PR and the Eastern Caribbean. The Yale-TCC (U54MD010711) leverages the infrastructure and knowledge of the ECHORN, expands to include New York and New Jersey and focuses on diabetes and hypertension. The investigators' network includes community advisory boards as well as policy delegations that are well suited to inform this project and its expansion into routine healthcare practice and policy.
The control arm of this study was never activated due to COVID-19 restrictions.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 114
- BMI>25 or WC>88/102cm
- No history of type I or type II diabetes or gestational diabetes
- Not on blood sugar altering medication
- Ability to attend weekly sessions
- HbA1c 6-6.4%
- Pregnant
- eGFR<45 mL/min/1.73 m2
- Prescribed Metformin and randomized to the control arm
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Lifestyle Intervention Highest risk pre-diabetic patients Intervention Metformin Highest risk pre-diabetic patients
- Primary Outcome Measures
Name Time Method Change in Hemoglobin A1c (HbA1c) Baseline and 12 months Hemoglobin A1C (HbA1C) test was assessed via clinical tests.
- Secondary Outcome Measures
Name Time Method Change in Fruit and Vegetable Intake (Total Servings) Baseline and 6 months Total mean servings per day of fruit and vegetables self report via electronic survey.
Change in Weight (kg) Baseline and 6 months Weight in kilograms (kg) assessed via clinical tests.
Change in Systolic Blood Pressure Baseline and 6 months Systolic blood pressure assessed via clinical tests.
Diabetes Risk Score 6 months The Diabetes Risk Score has been designed to be a screening tool for identifying high-risk subjects in the population and for increasing awareness of the modifiable risk factors and healthy lifestyle. The score ranges from 0-20, with a higher score indicating higher risk.
Change in Diastolic Blood Pressure Baseline and 6 months Diastolic blood pressure assessed via clinical tests.
Change in Self-Efficacy Score - Worry Scale 6 months The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.
Change in Self-Efficacy Score - Personal Control Scale Baseline and 6 months The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.
Change in Physical Activity Level. Baseline and 6 months Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire
Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day) Baseline and 6 months Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey.
Trial Locations
- Locations (4)
Ministry of Health Clinics
🇻🇮Charlotte Amalie, Virgin Islands (U.S.)
Southwest Regional Health Authority, La Romaine Health Center
🇹🇹San Fernando, Trinidad and Tobago
University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics
🇧🇧Bridgetown, Barbados
Internal Medicine Clinic at the University of Puerto Rico Hospital
🇵🇷Carolina, Puerto Rico