Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Stanford University
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Body Mass Index (BMI) - Post-Test
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study aims to test the effectiveness of a Type 2 Diabetes (T2D) prevention program for individuals who have been diagnosed with prediabetes compared to a T2D educational control group. Project health is an obesity prevention program and has produced a 42% to 53% reduction in future onset of overweight/obesity and also produced greater reductions in negative affect compared to assessment-only controls that persisted. Project Health has been adapted to prevent onset of T2D among individuals with prediabetes. The study aims to test the effectiveness of Project Health at reducing BMI, HbA1c levels, increase physical activity and improve glucose control.
Investigators
Eric Stice
Professor
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Between the ages of 18 and 65
- •Overweight (BMI between 25 and 40 kg/m2)
- •Diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
Exclusion Criteria
- •Not between the ages of 18 and 65
- •Not overweight (BMI between 25 and 40 kg/m2)
- •Not diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
Outcomes
Primary Outcomes
Body Mass Index (BMI) - Post-Test
Time Frame: post-test (immediately after completion of 6 week intervention)
BMI will be assessed at post-test to see which intervention produced greater reductions in BMI
Body Mass Index (BMI) - 3-Month Follow-Up
Time Frame: 3-month follow-up
BMI will be assessed at 3-month follow-up to see which intervention produced greater reductions in BMI
HbA1c at 3-month Follow-up
Time Frame: 3-month follow-up
Participants will complete an HbA1c test at 3-month follow-up to determine their pre-diabetes status
Fasting Plasma Glucose
Time Frame: 3-month follow-up
Participants will complete a fasting glucose test at 3-month follow-up to determine their pre-diabetes status
Percent Body Fat - Post-Test
Time Frame: post-test (immediately after completion of 6 week intervention)
Percent Body Fat - 3-Month Follow-Up
Time Frame: 3-month follow-up
Percent Lean Body Mass - Post-Test
Time Frame: post-test (immediately after completion of 6 week intervention)
Percent Lean Body Mass - 3-Month Follow-Up
Time Frame: 3-month follow-up