Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prediabetes
- Sponsor
- The Cleveland Clinic
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Effect of "FRESH" Program on Weight Loss
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Linda Libertini
Research Coordinator
The Cleveland Clinic
Eligibility Criteria
Inclusion Criteria
- •Study participants must:
- •Be capable of giving informed consent
- •Understand and voluntarily sign the informed consent form.
- •Be females at least 18 years of age and identify themselves as African-American
- •Have prediabetes as defined by the American Diabetes Association: history of glycated hemoglobin (HgbA1c) 5.7-6.4 % or fasting blood glucose 100-125 mg/dL (5.6-6.9 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose 140-199 mg/dL (7.8-11.0 mmol/L) during an oral glucose tolerance test (as described by the World Health Organization using a glucose load of 75 g anhydrous glucose dissolved in water)
- •Have a body mass index (BMI, defined as weight in kilograms divided by height in meters squared) greater than or equal to 25
Exclusion Criteria
- •Current or previous diagnosis of diabetes or a history of HgbA1c ≥ 6.5% or fasting blood glucose ≥ 126 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test or a history of classic symptoms of hyperglycemia or hyperglycemic crisis and a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).
- •Normal glycemia or a currently with a HgbA1c \< 5.7% or fasting blood glucose \< 100 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose \< 140 mg/dL (11.1 mmol/L) during an oral glucose tolerance test
- •Current or past use of oral hypoglycemic agents (including, but not limited to, metformin, rosiglitazone, pioglitazone, glipizide, and glyburide) or insulin
- •Male gender
- •History of congestive heart failure
- •History of renal failure, dialysis, or creatinine greater than 2 mg/dL
- •History of liver failure or a liver dysfunction with a increase by a factor of 2 above the upper limit of normal in alanine aminotransferase or aspartate aminotransferase
- •History of gastrointestinal disorder that would prevent adherence to the recommended diet (e.g. celiac disease, inflammatory bowel disease, history of bariatric surgery, history of intestinal surgery)
- •Presence of active cancer
- •History of coronary artery disease or cerebrovascular disease
Outcomes
Primary Outcomes
Effect of "FRESH" Program on Weight Loss
Time Frame: Baseline line and final followup visit (at 8-14 weeks)
Change in weight measured at baseline and followup (at 8-14 weeks).
Secondary Outcomes
- Diet - Daily Calorie Intake(Baseline and final followup visit (at 8-14 weeks))
- Stress(baseline and followup visit (at 8-14 weeks))
- Sleep(baseline and followup visit (at 8-14 weeks))
- Exercise(Baseline and final followup visits (at 8-14 weeks))