N/A
N=62
Evaluating a Type 2 Diabetes Prevention Program
Type 2 Diabetes · PreDiabetes
Bottom Line
View on ClinicalTrials.gov: NCT05822648 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Body Mass Index (BMI) - Post-Test — 30.3; 28.8 kg/m2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Project Health (Behavioral); Educational Video Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index (BMI) - Post-Test |
30.3; 28.8 | — |
| PRIMARY Body Mass Index (BMI) - 3-Month Follow-Up |
30.3; 28.7 | — |
| PRIMARY HbA1c at 3-month Follow-up |
5.8; 6 | — |
| PRIMARY Fasting Plasma Glucose |
107; 108 | — |
| PRIMARY Percent Body Fat - Post-Test |
39.2; 38.4 | — |
| PRIMARY Percent Body Fat - 3-Month Follow-Up |
38.3; 37.8 | — |
| PRIMARY Percent Lean Body Mass - Post-Test |
60.9; 61.6 | — |
| PRIMARY Percent Lean Body Mass - 3-Month Follow-Up |
61.6; 62.2 | — |
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.
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%).
Data sourced from ClinicalTrials.gov (NCT05822648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.