Stephanie Tubbs Jones Health Center
East Cleveland, Ohio, 44112, United States
NCT Number: NCT01636258
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
East Cleveland, Ohio, 44112, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Every other week
Every other week
Every week
Every other week
Time frame: Baseline line and final followup visit (at 8-14 weeks)
Change in weight measured at baseline and followup (at 8-14 weeks).
Time frame: Baseline and final followup visit (at 8-14 weeks)
Change in daily caloric intake as measured by online 24-hour recall dietary program
Time frame: Baseline and final followup visits (at 8-14 weeks)
Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).
Time frame: baseline and followup visit (at 8-14 weeks)
Change of Psychosocial Stress (PSS-10) scores (total range 0-40) measured at baseline and followup (at 8-14 weeks). Higher score reflects worse outcome.
Time frame: baseline and followup visit (at 8-14 weeks)
Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).
The Cleveland Clinic
Other
Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study
Acronym: FRESH
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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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