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Diabetes Prevention Program for Prediabetes

N/A
Waitlist Available
Led By Eric Stice, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%)
Between the ages of 18 and 65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-test, and three-month follow-up
Awards & highlights

Study Summary

This trial is testing the effectiveness of a T2D prevention program for those with prediabetes, which can reduce BMI, HbA1c levels, physical activity and glucose control.

Who is the study for?
This trial is for adults aged 18-65 who have been diagnosed with prediabetes, indicated by an HbA1c level between 5.7% and 6.4%, and are overweight with a BMI of 25 to 40 kg/m2.Check my eligibility
What is being tested?
The study compares the 'Project Health' T2D prevention program, which aims to reduce body weight and improve blood sugar levels, against a control group that receives only diabetes education through videos.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include discomfort from increased physical activity or psychological effects due to dietary restrictions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My HbA1c levels show I have prediabetes.
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-test, post-test (immediately after completion of 6 week intervention) and three-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-test, post-test (immediately after completion of 6 week intervention) and three-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change over time in Body Mass Index (BMI)
Change over time in HbA1c
Secondary outcome measures
Change over time in self-reported caloric intake

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Project Health
2012
N/A
~370

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,338 Previous Clinical Trials
4,314,139 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,867 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,622 Total Patients Enrolled

Media Library

Project Health Clinical Trial Eligibility Overview. Trial Name: NCT05822648 — N/A
Prediabetes Research Study Groups: Control, Intervention
Prediabetes Clinical Trial 2023: Project Health Highlights & Side Effects. Trial Name: NCT05822648 — N/A
Project Health 2023 Treatment Timeline for Medical Study. Trial Name: NCT05822648 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project admit participants that are younger than sixty years old?

"This medical research is seeking to enrol participants that are of legal age and below the retirement threshold."

Answered by AI

What criteria must be met in order to enroll in this clinical experiment?

"To gain entry to this trial, candidates must have prediabetes and be of age between 18-65. The research team hopes to enroll a total of 60 participants."

Answered by AI

Is there a way to gain access to the ongoing clinical trial?

"According to clinicaltrials.gov, this trial is actively enrolling participants after first being posted on April 15th 2023 and most recently updated on May 18th 2023."

Answered by AI

What is the participant capacity of this clinical trial?

"Affirmative. Clinicaltrials.gov has the details of this medical study which was initiated on April 15th, 2023 and is still accepting patients for recruitment. Sixty participants are needed from one location to complete this trial."

Answered by AI
~31 spots leftby Mar 2025