Evaluating a Type 2 Diabetes Prevention Program

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability

Conditions
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Type 2 Diabetes, PreDiabetes

Intervention / Treatment
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* Behavioral: Project Health
* Other: Educational Video Control


Participation Criteria
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Eligibility Criteria
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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%).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| Active Comparator: Control<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, Type 2 Diabetes, prediabetes, group intervention