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Completed

NCT Number: NCT05822648

Evaluating a Type 2 Diabetes Prevention Program

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

Project Health

Behavioral

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.

Educational Video Control

Other

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 outcomes

  1. Body Mass Index (BMI) - Post-Test

    Time frame: post-test (immediately after completion of 6 week intervention)

    BMI will be assessed at post-test to see which intervention produced greater reductions in BMI

  2. Body Mass Index (BMI) - 3-Month Follow-Up

    Time frame: 3-month follow-up

    BMI will be assessed at 3-month follow-up to see which intervention produced greater reductions in BMI

  3. HbA1c at 3-month Follow-up

    Time frame: 3-month follow-up

    Participants will complete an HbA1c test at 3-month follow-up to determine their pre-diabetes status

  4. Fasting Plasma Glucose

    Time frame: 3-month follow-up

    Participants will complete a fasting glucose test at 3-month follow-up to determine their pre-diabetes status

  5. Percent Body Fat - Post-Test

    Time frame: post-test (immediately after completion of 6 week intervention)

  6. Percent Body Fat - 3-Month Follow-Up

    Time frame: 3-month follow-up

  7. Percent Lean Body Mass - Post-Test

    Time frame: post-test (immediately after completion of 6 week intervention)

  8. Percent Lean Body Mass - 3-Month Follow-Up

    Time frame: 3-month follow-up

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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