Evaluating a Type 2 Diabetes Prevention Program

Not Applicable

Completed

• Conditions: Type 2 Diabetes; PreDiabetes
• Interventions: Other: Educational Video Control; Behavioral: Project Health

• Registration Number: NCT05822648
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-07
• Study Start: 2023-04-15
• Study First Posted: 2023-04-21
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Results First Submitted: 2025-03-17
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Results First Posted: 2025-04-04
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Between the ages of 18 and 65
2. Overweight (BMI between 25 and 40 kg/m2)
3. Diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).

Exclusion Criteria

1. Not between the ages of 18 and 65
2. Not overweight (BMI between 25 and 40 kg/m2)
3. Not diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Educational Video Control	We selected a T2D management psychoeducational comparison condition. To match Project Health, the educational videos will be delivered in 6 1-hour blocks. The educational group will be instructed to watch videos on nutrition, exercise, and how to maintain general health during the lifespan
Intervention	Project Health	Project Health will be delivered in six 1-hour group sessions that will be held weekly. In addition, participants will be asked to complete 30 mins of response inhibition and attention trainings once per week between the sessions. This program promotes to retain the gradual lifestyle modification designed to bring energy intake into balance with energy output and the food response inhibition and attention training, but will adapt the dissonance-induction activities to focus on the negative effects of developing T2D in addition to the negative effects of obesity, overeating, and a sedentary lifestyle.

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI) - Post-Test	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	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	3-month follow-up	Participants will complete an HbA1c test at 3-month follow-up to determine their pre-diabetes status
Fasting Plasma Glucose	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	post-test (immediately after completion of 6 week intervention)
Percent Body Fat - 3-Month Follow-Up	3-month follow-up
Percent Lean Body Mass - Post-Test	post-test (immediately after completion of 6 week intervention)
Percent Lean Body Mass - 3-Month Follow-Up	3-month follow-up

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States