Evaluating a Type 2 Diabetes Prevention Program

Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PreDiabetes; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Project Health; Other: Educational Video Control

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Rubino, BA; Phone Number: 6505494829; Email: lrubino@stanford.edu
• Study Contact Backup: Name: Kristeen Gee, BA; Email: ktgee@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
Active Comparator: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change over time in Body Mass Index (BMI)	BMI will be assessed at each time point to see which intervention produced greater reductions in BMI	pre-test, post-test (immediately after completion of 6 week intervention), and three-month follow-up
Change over time in HbA1c	Participants will complete an at-home HbA1c self-collection kit at each time point	pre-test, and three-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change over time in self-reported caloric intake	Participants will complete the Automated Self-Administered 24-hr Dietary Recall (ASA-24) to assess dietary intake on 2 weekdays and 1 weekend	pre-test, post-test (immediately after completion of 6 week intervention) and three-month follow-up

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Eric Stice, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): April 19, 2024
• Study Completion (Estimated): April 19, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; prevention; prediabetes; group intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 68320; P30DK116074 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes