Evaluating a Type 2 Diabetes Prevention Program

Type 2 Diabetes Clinical Trial

Official title:

Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822648
• Other study ID #: 68320
• Secondary ID: P30DK116074
• Status: Completed
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: April 22, 2024

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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%).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

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.

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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