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Evaluating a Type 2 Diabetes Prevention Program

Primary Purpose

Type 2 Diabetes, PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Health
Educational Video Control
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring prevention, Type 2 Diabetes, prediabetes, group intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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%). Exclusion Criteria: 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%).

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2023
Last Updated
May 18, 2023
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05822648
Brief Title
Evaluating a Type 2 Diabetes Prevention Program
Official Title
Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, PreDiabetes
Keywords
prevention, Type 2 Diabetes, prediabetes, group intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator and follow-up assessors will be blinded to condition
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Project Health
Intervention Description
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 Type
Other
Intervention Name(s)
Educational Video Control
Intervention Description
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
Primary Outcome Measure Information:
Title
Change over time in Body Mass Index (BMI)
Description
BMI will be assessed at each time point to see which intervention produced greater reductions in BMI
Time Frame
pre-test, post-test (immediately after completion of 6 week intervention), and three-month follow-up
Title
Change over time in HbA1c
Description
Participants will complete an at-home HbA1c self-collection kit at each time point
Time Frame
pre-test, and three-month follow-up
Secondary Outcome Measure Information:
Title
Change over time in self-reported caloric intake
Description
Participants will complete the Automated Self-Administered 24-hr Dietary Recall (ASA-24) to assess dietary intake on 2 weekdays and 1 weekend
Time Frame
pre-test, post-test (immediately after completion of 6 week intervention) and three-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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%). Exclusion Criteria: 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%).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Rubino, BA
Phone
6505494829
Email
lrubino@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristeen Gee, BA
Email
ktgee@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Gee, BS
Phone
650-285-2049
Email
ktgee@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating a Type 2 Diabetes Prevention Program

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