FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)

Study Overview
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Brief Summary
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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
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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

Official Title
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Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study

Conditions
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Prediabetes, Overweight

Intervention / Treatment
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* Behavioral: Stress Management
* Behavioral: Diet
* Behavioral: Exercise
* Behavioral: Culinary education


Participation Criteria
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Eligibility Criteria
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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 History of uncontrolled hypertension Participation in another lifestyle modification trial Pregnancy or lactating or planning to be pregnant Current alcoholism or abuse of recreational drugs Hospitalization for depression in past 12 months Travel plans that do not permit full participation or participant lives too far from Health Center to permit full participation History of bariatric surgery, small bowel resection, or extensive bowel resection Chronic treatment with systemic steroids Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder Inability to walk two blocks Other medial, psychiatric, or behavioral limitations that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol Amputation of lower limb for nontraumatic causes Self report of HIV-positivity or active tuberculosis Documented history of pulmonary embolus in past six months Chronic obstructive pulmonary disease that would limit ability to follow the study protocol Self-reported chronic hepatitis B or C or cirrhosis; inflammatory bowel disease requiring treatment in past year; Cushing's syndrome; acromegaly (clinical diagnosis or self-report); any major organ transplant Unwilling or uninterested in participating in group lifestyle education sessions Current regular corticosteroid use Active polycystic ovarian syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm A: Control group<br>These participants will continue to receive their usual care from their primary medical care team. | |
| Experimental: Arm B<br>Arm includes diet instruction, exercise, stress management, and culinary education | Behavioral: Stress Management<br>* Every other week<br>Behavioral: Diet<br>* Every other week<br>Behavioral: Exercise<br>* Every week<br>Behavioral: Culinary education<br>* Every other week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of FRESH Program on Weight Loss | Change in weight measured at baseline and followup (at 8-14 weeks). | Baseline line and final followup visit (at 8-14 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet - Daily Calorie Intake | Change in daily caloric intake as measured by online 24-hour recall dietary program | 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). | 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. | 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). | baseline and followup visit (at 8-14 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetes, Overweight, African American, Women, Cooking, Nutrition, Exercise, Stress Management