Evaluating a Type 2 Diabetes Prevention Program

NCT05822648 | Completed Results

• 2 other identifiers: 68320P30DK116074
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; PreDiabetes

Keywords

prevention; Type 2 Diabetes; prediabetes; group intervention

Outcome Measures

Primary Outcomes (8)

• Body Mass Index (BMI) - Post-Test

  BMI will be assessed at post-test to see which intervention produced greater reductions in BMI

  post-test (immediately after completion of 6 week intervention)

• Body Mass Index (BMI) - 3-Month Follow-Up

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

  3-month follow-up

• HbA1c at 3-month Follow-up

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

  3-month follow-up

• Fasting Plasma Glucose

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

  3-month follow-up

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Project Health

Control

ACTIVE COMPARATOR

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

Other: Educational Video Control

Interventions

Project Health BEHAVIORAL

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.

Intervention

Educational Video Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Eric Stice
• Organization: Stanford University

estice@stanford.edu

650-723-7885

Study Officials

• Eric Stice, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and follow-up assessors will be blinded to condition
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 21, 2023
• Study Start: April 15, 2023
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: April 4, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)