Trial Outcomes & Findings for Diabetes Prevention With Lifestyle Intervention and Metformin Escalation (NCT NCT03258723)
NCT ID: NCT03258723
Last Updated: 2024-02-06
Results Overview
Hemoglobin A1C (HbA1C) test was assessed via clinical tests.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
114 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2024-02-06
Participant Flow
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".
Participant milestones
| Measure |
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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Overall Study
STARTED
|
114
|
|
Overall Study
6 Month Follow up
|
80
|
|
Overall Study
12 Month Follow up
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
62
|
Reasons for withdrawal
| Measure |
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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|---|---|
|
Overall Study
COVID Interruption of study
|
54
|
|
Overall Study
Lost to Follow-up
|
8
|
Baseline Characteristics
1 participant missing education information.
Baseline characteristics by cohort
| Measure |
Intervention
n=114 Participants
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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|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 5.7 • n=114 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African or Caribbean
|
67 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
26 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino or Puerto Rican
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Mixed or multi-racial
|
18 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown/Missing
|
1 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=114 Participants
|
|
Education
Less than high school
|
14 Participants
n=113 Participants • 1 participant missing education information.
|
|
Education
High school
|
45 Participants
n=113 Participants • 1 participant missing education information.
|
|
Education
Some college
|
28 Participants
n=113 Participants • 1 participant missing education information.
|
|
Education
College or more
|
26 Participants
n=113 Participants • 1 participant missing education information.
|
|
HbA1c
|
6.2 percentage
STANDARD_DEVIATION 0.1 • n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: All participants with valid data on matched cases at baseline and 12 months.
Hemoglobin A1C (HbA1C) test was assessed via clinical tests.
Outcome measures
| Measure |
Intervention
n=51 Participants
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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|---|---|
|
Change in Hemoglobin A1c (HbA1c)
Baseline
|
6.19 percentage
Standard Deviation 0.15
|
|
Change in Hemoglobin A1c (HbA1c)
12 Months
|
5.67 percentage
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with valid data that could be matched from baseline to 6 months.
Weight in kilograms (kg) assessed via clinical tests.
Outcome measures
| Measure |
Intervention
n=76 Participants
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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|---|---|
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Change in Weight (kg)
6 Months
|
85.00 kg
Standard Deviation 16.86
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Change in Weight (kg)
Baseline
|
86.66 kg
Standard Deviation 16.63
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SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with valid data matched from baseline to 6 months.
Systolic blood pressure assessed via clinical tests.
Outcome measures
| Measure |
Intervention
n=74 Participants
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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|---|---|
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Change in Systolic Blood Pressure
Baseline
|
133.93 mmHg
Standard Deviation 20.72
|
|
Change in Systolic Blood Pressure
6 Months
|
131.64 mmHg
Standard Deviation 18.54
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with valid data matched from baseline to 6 months.
Diastolic blood pressure assessed via clinical tests.
Outcome measures
| Measure |
Intervention
n=74 Participants
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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|---|---|
|
Change in Diastolic Blood Pressure
6 Months
|
82.54 mmHg
Standard Deviation 10.49
|
|
Change in Diastolic Blood Pressure
Baseline
|
84.86 mmHg
Standard Deviation 11.87
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SECONDARY outcome
Timeframe: 6 monthsPopulation: These data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Matched cases with valid data.
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.
Outcome measures
| Measure |
Intervention
n=68 Participants
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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|---|---|
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Change in Self-Efficacy Score - Personal Control Scale
Baseline
|
3.55 units on a scale
Standard Deviation 0.50
|
|
Change in Self-Efficacy Score - Personal Control Scale
6 Months
|
3.64 units on a scale
Standard Deviation 0.43
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Matched cases with valid data.
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.
Outcome measures
| Measure |
Intervention
n=68 Participants
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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|---|---|
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Change in Self-Efficacy Score - Worry Scale
Baseline
|
2.88 units on a scale
Standard Deviation 1.01
|
|
Change in Self-Efficacy Score - Worry Scale
6 Months
|
2.83 units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with valid data that could be matched from baseline to 6 months.
Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire
Outcome measures
| Measure |
Intervention
n=70 Participants
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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|---|---|
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Change in Physical Activity Level.
Baseline · Low
|
22 Participants
|
|
Change in Physical Activity Level.
Baseline · Moderate
|
22 Participants
|
|
Change in Physical Activity Level.
Baseline · High
|
26 Participants
|
|
Change in Physical Activity Level.
6 Months · Low
|
28 Participants
|
|
Change in Physical Activity Level.
6 Months · Moderate
|
18 Participants
|
|
Change in Physical Activity Level.
6 Months · High
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with valid data that could be matched from baseline to 6 months.
Total mean servings per day of fruit and vegetables self report via electronic survey.
Outcome measures
| Measure |
Intervention
n=70 Participants
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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|---|---|
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Change in Fruit and Vegetable Intake (Total Servings)
Baseline
|
1.53 daily servings
Standard Deviation 0.97
|
|
Change in Fruit and Vegetable Intake (Total Servings)
6 Months
|
1.61 daily servings
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Participants with valid data that could be matched from baseline to 6 months.
Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey.
Outcome measures
| Measure |
Intervention
n=68 Participants
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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|---|---|
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Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)
Baseline
|
7.30 teaspoons
Standard Deviation 8.08
|
|
Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)
6 Months
|
3.83 teaspoons
Standard Deviation 4.10
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marcella Nunez-Smith, MD, MHS
Yale School of Medicine
Phone: (203) 785-6454
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place