Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT01636258
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2012-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRESH
Brief Summary:
To examine whether a lifestyle program results in weight loss and thereby delays or prevents progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6 weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants are randomized to receive all of the following: nutrition education, exercise instruction, stress management instruction, and culinary education or follow usual care. Outcomes include: blood sugars and cholesterol, weight, waist circumference, blood pressure, diet, physical activity, perceived stress, and class attendance. Analysis is by Intention to treat analysis of variance. Results will be used to help design larger randomized trial in the future.
Detailed Description:
Control group:
These participants will continue to receive their usual care from their primary medical care team.
Intervention group:
The participants will receive nutrition education, exercise instruction, stress management instruction,and culinary education
These participants will continue to receive their usual care from their primary medical care team.
Intervention group:
The participants will receive nutrition education, exercise instruction, stress management instruction,and culinary education
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: