Evaluating a Type 2 Diabetes Prevention Program

Stanford University

Status: Completed

Conditions: Type 2 Diabetes; PreDiabetes

Treatments: Other: Educational Video Control; Behavioral: Project Health

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05822648

P30DK116074 (U.S. NIH Grant/Contract)

68320

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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%).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

62 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

Behavioral: Project Health

Control

Active Comparator group

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

Treatment:

Other: Educational Video Control