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

Not Applicable

Completed

Conditions: Overweight
Prediabetes

Interventions: Behavioral: Stress Management
Behavioral: Diet
Behavioral: Exercise
Behavioral: Culinary education

Registration Number: NCT01636258

Lead Sponsor: The Cleveland Clinic

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 27

Inclusion Criteria

Study participants must:
1. Be capable of giving informed consent
2. Understand and voluntarily sign the informed consent form.
3. Be females at least 18 years of age and identify themselves as African-American
4. 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)
5. 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Diet	Arm includes diet instruction, exercise, stress management, and culinary education
Arm B	Exercise	Arm includes diet instruction, exercise, stress management, and culinary education
Arm B	Culinary education	Arm includes diet instruction, exercise, stress management, and culinary education
Arm B	Stress Management	Arm includes diet instruction, exercise, stress management, and culinary education

Primary Outcome Measures

Name	Time	Method
Effect of "FRESH" Program on Weight Loss	Baseline line and final followup visit (at 8-14 weeks)	Change in weight measured at baseline and followup (at 8-14 weeks).

Secondary Outcome Measures

Name	Time	Method
Diet - Daily Calorie Intake	Baseline and final followup visit (at 8-14 weeks)	Change in daily caloric intake as measured by online 24-hour recall dietary program
Stress	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.
Sleep	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).
Exercise	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).