Diabetes
Conditions
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.
Interventions
BEHAVIORALLifestyle 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.
DRUGMetformin
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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%
Exclusion criteria
* Pregnant * eGFR\<45 mL/min/1.73 m2 * Prescribed Metformin and randomized to the control arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) | Baseline and 12 months | Hemoglobin A1C (HbA1C) test was assessed via clinical tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | Baseline and 6 months | Systolic blood pressure assessed via clinical tests. |
| Change in Diastolic Blood Pressure | Baseline and 6 months | Diastolic 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 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 Weight (kg) | Baseline and 6 months | Weight in kilograms (kg) assessed via clinical tests. |
| 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 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 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. |
| 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. |
Countries
Barbados, Puerto Rico, Trinidad and Tobago, Virgin Islands
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 114 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | COVID Interruption of study | 54 |
| Overall Study | Lost to Follow-up | 8 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 5.7 |
| Education College or more | 26 Participants |
| Education High school | 45 Participants |
| Education Less than high school | 14 Participants |
| Education Some college | 28 Participants |
| HbA1c | 6.2 percentage STANDARD_DEVIATION 0.1 |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 26 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African or Caribbean | 67 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino or Puerto Rican | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Mixed or multi-racial | 18 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown/Missing | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 1 Participants |
| Region of Enrollment United States | 114 participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 114 |
| other Total, other adverse events | 0 / 114 |
| serious Total, serious adverse events | 0 / 114 |
Outcome results
Primary
Change in Hemoglobin A1c (HbA1c)
Hemoglobin A1C (HbA1C) test was assessed via clinical tests.
Time frame: Baseline and 12 months
Population: All participants with valid data on matched cases at baseline and 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Hemoglobin A1c (HbA1c) | Baseline | 6.19 percentage | Standard Deviation 0.15 |
| Intervention | Change in Hemoglobin A1c (HbA1c) | 12 Months | 5.67 percentage | Standard Deviation 0.5 |
Comparison: Within group change from baseline assessed on matched cases.p-value: <0.0001t-test, 2 sided
Secondary
Change in Diastolic Blood Pressure
Diastolic blood pressure assessed via clinical tests.
Time frame: Baseline and 6 months
Population: Participants with valid data matched from baseline to 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diastolic Blood Pressure | Baseline | 84.86 mmHg | Standard Deviation 11.87 |
| Intervention | Change in Diastolic Blood Pressure | 6 Months | 82.54 mmHg | Standard Deviation 10.49 |
Comparison: Within group change from baseline assessed on matched cases.p-value: 0.0973t-test, 2 sided
Secondary
Change in Fruit and Vegetable Intake (Total Servings)
Total mean servings per day of fruit and vegetables self report via electronic survey.
Time frame: Baseline and 6 months
Population: Participants with valid data that could be matched from baseline to 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Fruit and Vegetable Intake (Total Servings) | Baseline | 1.53 daily servings | Standard Deviation 0.97 |
| Intervention | Change in Fruit and Vegetable Intake (Total Servings) | 6 Months | 1.61 daily servings | Standard Deviation 1.02 |
Comparison: Within group change from baseline assessed on matched cases.p-value: 0.5271t-test, 2 sided
Secondary
Change in Physical Activity Level.
Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire
Time frame: Baseline and 6 months
Population: Participants with valid data that could be matched from baseline to 6 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Change in Physical Activity Level. | Baseline | Low | 22 Participants |
| Intervention | Change in Physical Activity Level. | Baseline | Moderate | 22 Participants |
| Intervention | Change in Physical Activity Level. | Baseline | High | 26 Participants |
| Intervention | Change in Physical Activity Level. | 6 Months | Low | 28 Participants |
| Intervention | Change in Physical Activity Level. | 6 Months | Moderate | 18 Participants |
| Intervention | Change in Physical Activity Level. | 6 Months | High | 24 Participants |
Comparison: Within group change from baseline assessed on matched cases in low activity group at baseline.p-value: 0.1573McNemar
Comparison: Within group change from baseline assessed on matched cases in medium activity group at baseline.p-value: 0.4328McNemar
Comparison: Within group change from baseline assessed on matched cases in high activity group at baseline.p-value: 0.6698McNemar
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.
Time frame: Baseline and 6 months
Population: Matched cases with valid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Self-Efficacy Score - Personal Control Scale | Baseline | 3.55 units on a scale | Standard Deviation 0.5 |
| Intervention | Change in Self-Efficacy Score - Personal Control Scale | 6 Months | 3.64 units on a scale | Standard Deviation 0.43 |
Comparison: Within subject change on matched cases.p-value: 0.1992t-test, 2 sided
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.
Time frame: 6 months
Population: Matched cases with valid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Self-Efficacy Score - Worry Scale | Baseline | 2.88 units on a scale | Standard Deviation 1.01 |
| Intervention | Change in Self-Efficacy Score - Worry Scale | 6 Months | 2.83 units on a scale | Standard Deviation 0.94 |
Comparison: Within subject change on matched cases.p-value: 0.7017t-test, 2 sided
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.
Time frame: Baseline and 6 months
Population: Participants with valid data that could be matched from baseline to 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day) | Baseline | 7.30 teaspoons | Standard Deviation 8.08 |
| Intervention | Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day) | 6 Months | 3.83 teaspoons | Standard Deviation 4.1 |
Comparison: Within group change from baseline assessed on matched cases.p-value: <0.0001t-test, 2 sided
Secondary
Change in Systolic Blood Pressure
Systolic blood pressure assessed via clinical tests.
Time frame: Baseline and 6 months
Population: Participants with valid data matched from baseline to 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Systolic Blood Pressure | Baseline | 133.93 mmHg | Standard Deviation 20.72 |
| Intervention | Change in Systolic Blood Pressure | 6 Months | 131.64 mmHg | Standard Deviation 18.54 |
Comparison: Within group change from baseline assessed on matched cases.p-value: 0.1809t-test, 2 sided
Secondary
Change in Weight (kg)
Weight in kilograms (kg) assessed via clinical tests.
Time frame: Baseline and 6 months
Population: Participants with valid data that could be matched from baseline to 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Weight (kg) | Baseline | 86.66 kg | Standard Deviation 16.63 |
| Intervention | Change in Weight (kg) | 6 Months | 85.00 kg | Standard Deviation 16.86 |
Comparison: Within group change from baseline assessed on matched cases.p-value: 0.0005t-test, 2 sided
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.
Time frame: 6 months
Population: These data were not collected.