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Evaluating a Type 2 Diabetes Prevention Program

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05822648
Collaborator
(none)
60
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Project Health
  • Other: Educational Video Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
The investigator and follow-up assessors will be blinded to condition
Primary Purpose:
Prevention
Official Title:
Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change over time in Body Mass Index (BMI) [pre-test, post-test (immediately after completion of 6 week intervention), and three-month follow-up]

    BMI will be assessed at each time point to see which intervention produced greater reductions in BMI

  2. Change over time in HbA1c [pre-test, and three-month follow-up]

    Participants will complete an at-home HbA1c self-collection kit at each time point

Secondary Outcome Measures

  1. Change over time in self-reported caloric intake [pre-test, post-test (immediately after completion of 6 week intervention) and three-month follow-up]

    Participants will complete the Automated Self-Administered 24-hr Dietary Recall (ASA-24) to assess dietary intake on 2 weekdays and 1 weekend

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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%).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Eric Stice, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eric Stice, Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT05822648
Other Study ID Numbers:
  • 68320
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Eric Stice, Professor, Stanford University
prevention
Type 2 Diabetes
prediabetes
group intervention
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance

Study Results

No Results Posted as of Apr 21, 2023