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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
27
Every other week
Every other week
Every week
Every other week
Stephanie Tubbs Jones Health Center
East Cleveland, Ohio, United States
Effect of "FRESH" Program on Weight Loss
Change in weight measured at baseline and followup (at 8-14 weeks).
Time frame: Baseline line and final followup visit (at 8-14 weeks)
Diet - Daily Calorie Intake
Change in daily caloric intake as measured by online 24-hour recall dietary program
Time frame: Baseline and final followup visit (at 8-14 weeks)
Exercise
Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).
Time frame: Baseline and final followup visits (at 8-14 weeks)
Stress
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)
Sleep
Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).
Time frame: baseline and followup visit (at 8-14 weeks)
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