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| ID | Type | Description | Link |
|---|---|---|---|
| 1K12HL138037-01 | U.S. NIH Grant/Contract | View source | |
| 1U54MD010711-01 | U.S. NIH Grant/Contract | View source |
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COVID-19 led to changes in study design and an early end to data collection.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Highest risk pre-diabetic patients |
|
| Control | No Intervention | Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited. ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Intervention | Behavioral | The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control. The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) | Hemoglobin A1C (HbA1C) test was assessed via clinical tests. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight (kg) | Weight in kilograms (kg) assessed via clinical tests. | Baseline and 6 months |
| Change in Systolic Blood Pressure | Systolic blood pressure assessed via clinical tests. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcella Nunez-Smith, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics | Bridgetown | Barbados | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41275221 | Derived | Hassan S, Sobers NP, Paul-Charles J, Herbert J, Dharamraj K, Galusha D, Cruz E, Garcia-Rivera E, Fredericks L, Arniella G, Cattamanchi A, Adams OP, Maharaj RG, Nazario CM, Nunez M, Nunez-Smith M. Diabetes prevention in the Caribbean using lifestyle intervention and Metformin escalation (LIME): results from a quasi-experimental study. BMC Public Health. 2025 Nov 22;25(1):4409. doi: 10.1186/s12889-025-25291-7. |
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A total of 211 participants agreed to be a part of the study, 114 participants attended at least 1 workshop and are those considered "enrolled".
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Highest risk pre-diabetic patients Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control. The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series. Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Highest risk pre-diabetic patients Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control. The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series. Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hemoglobin A1c (HbA1c) | Hemoglobin A1C (HbA1C) test was assessed via clinical tests. | All participants with valid data on matched cases at baseline and 12 months. | Posted | Mean | Standard Deviation | percentage | Baseline and 12 months |
|
Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Highest risk pre-diabetic patients Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control. The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series. Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcella Nunez-Smith, MD, MHS | Yale School of Medicine | (203) 785-6454 | marcella.nunez-smith@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2021 | Nov 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2022 | Nov 22, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2021 | Feb 1, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Patient Recruitment:
The investigators are targeting the highest risk pre-diabetic patients for this study. Patient recruitment will occur through the involved health clinics.
Control Participants Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited from the ECHORN Cohort Study (ECS).
ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups. These participants will be offered a delayed intervention at the end of 2.5years, given the evidence supporting behavioral modification for diabetes prevention.
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| Metformin | Drug | At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day. |
|
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| Baseline and 6 months |
| Change in Diastolic Blood Pressure | Diastolic blood pressure assessed via clinical tests. | Baseline and 6 months |
| Diabetes Risk Score | 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. | 6 months |
| Change in Self-Efficacy Score - Personal Control Scale | 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. | Baseline and 6 months |
| Change in Self-Efficacy Score - Worry Scale | 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. | 6 months |
| Change in Physical Activity Level. | Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire | Baseline and 6 months |
| Change in Fruit and Vegetable Intake (Total Servings) | Total mean servings per day of fruit and vegetables self report via electronic survey. | Baseline and 6 months |
| Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day) | Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey. | Baseline and 6 months |
| Internal Medicine Clinic at the University of Puerto Rico Hospital |
| Carolina |
| 00984 |
| Puerto Rico |
| Southwest Regional Health Authority, La Romaine Health Center | San Fernando | Trinidad and Tobago |
| Ministry of Health Clinics | Charlotte Amalie | Virgin Islands |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | 1 participant missing education information. | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | percentage |
|
|
|
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| Secondary | Change in Weight (kg) | Weight in kilograms (kg) assessed via clinical tests. | Participants with valid data that could be matched from baseline to 6 months. | Posted | Mean | Standard Deviation | kg | Baseline and 6 months |
|
|
|
|
| Secondary | Change in Systolic Blood Pressure | Systolic blood pressure assessed via clinical tests. | Participants with valid data matched from baseline to 6 months. | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
|
|
|
|
| Secondary | Change in Diastolic Blood Pressure | Diastolic blood pressure assessed via clinical tests. | Participants with valid data matched from baseline to 6 months. | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
|
|
|
|
| Secondary | Diabetes Risk Score | 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. | These data were not collected. | Posted | 6 months |
|
|
| Secondary | Change in Self-Efficacy Score - Personal Control Scale | 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. | Matched cases with valid data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
|
| Secondary | Change in Self-Efficacy Score - Worry Scale | 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. | Matched cases with valid data. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
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| Secondary | Change in Physical Activity Level. | Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire | Participants with valid data that could be matched from baseline to 6 months. | Posted | Count of Participants | Participants | Baseline and 6 months |
|
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|
|
| Secondary | Change in Fruit and Vegetable Intake (Total Servings) | Total mean servings per day of fruit and vegetables self report via electronic survey. | Participants with valid data that could be matched from baseline to 6 months. | Posted | Mean | Standard Deviation | daily servings | Baseline and 6 months |
|
|
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| Secondary | Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day) | Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey. | Participants with valid data that could be matched from baseline to 6 months. | Posted | Mean | Standard Deviation | teaspoons | Baseline and 6 months |
|
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|
|
| 0 |
| 114 |
| 0 |
| 114 |
| 0 |
| 114 |
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| 6 Months |
|
| 0.4328 |
| Superiority |
| Within group change from baseline assessed on matched cases in high activity group at baseline. | McNemar | 0.6698 | Superiority |