NCT05822648

Evaluating a Type 2 Diabetes Prevention Program

Completed NA Results posted Last updated 4 April 2025

What this trial tests

NA trial testing Project Health in Type 2 Diabetes in 62 participants. Completed in 22 April 2024.

Timeline

15 April 2023

Primary endpoint
22 April 2024

22 April 2024

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	62
Start date	15 April 2023
Primary completion	22 April 2024
Estimated completion	22 April 2024
Sites	1 location across United States

Drugs / interventions tested

• Project Health
• Educational Video Control

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →
• PreDiabetes — all drugs for PreDiabetes →

Sponsor

Stanford University

Who can join

Adults 18 to 65, any sex, with Type 2 Diabetes or PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Body Mass Index (BMI) - Post-Test Primary · 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

Group	Value	95% CI
Intervention	30.3	± 6.6
Control	28.8	± 5.3

Body Mass Index (BMI) - 3-Month Follow-Up Primary · 3-month follow-up

BMI will be assessed at 3-month follow-up to see which intervention produced greater reductions in BMI

Group	Value	95% CI
Intervention	30.3	± 6.5
Control	28.7	± 5.5

HbA1c at 3-month Follow-up Primary · 3-month follow-up

Participants will complete an HbA1c test at 3-month follow-up to determine their pre-diabetes status

Group	Value	95% CI
Intervention	5.8	± 0.4
Control	6	± 0.4

Fasting Plasma Glucose Primary · 3-month follow-up

Participants will complete a fasting glucose test at 3-month follow-up to determine their pre-diabetes status

Group	Value	95% CI
Intervention	107	± 12
Control	108	± 13

Percent Body Fat - Post-Test Primary · post-test (immediately after completion of 6 week intervention)

Group	Value	95% CI
Intervention	39.2	± 9.5
Control	38.4	± 7.8

Percent Body Fat - 3-Month Follow-Up Primary · 3-month follow-up

Group	Value	95% CI
Intervention	38.3	± 9.8
Control	37.8	± 8.0

Percent Lean Body Mass - Post-Test Primary · post-test (immediately after completion of 6 week intervention)

Group	Value	95% CI
Intervention	60.9	± 9.6
Control	61.6	± 7.8

Percent Lean Body Mass - 3-Month Follow-Up Primary · 3-month follow-up

Group	Value	95% CI
Intervention	61.6	± 9.7
Control	62.2	± 7.9

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A preliminary randomized trial of a brief dissonance-based type 2 diabetes prevention programme for adults with pre-diabetes.
   Stice E, Rohde P, Desjardins CD, Gee K, et al · · 2025 · PMID 39778041 · DOI 10.1111/dom.16170