FRESH Study (Fitness, Relaxation and Eating to Stay Healthy) (FRESH)
Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
East Cleveland, Ohio, United States, 44112
- Stephanie Tubbs Jones Health Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Arm A: Control group
These participants will continue to receive their usual care from their primary medical care team.
|
|
|
Experimental: Arm B
Arm includes diet instruction, exercise, stress management, and culinary education
|
Every other week
Every other week
Every week
Every other week
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline line and final followup visit (at 8-14 weeks)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet - Daily Calorie Intake
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
|
Baseline and final followup visit (at 8-14 weeks)
|
|
Exercise
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).
|
Baseline and final followup visits (at 8-14 weeks)
|
|
Stress
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.
|
baseline and followup visit (at 8-14 weeks)
|
|
Sleep
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).
|
baseline and followup visit (at 8-14 weeks)
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Adam M Bernstein, M.D., The Cleveland Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 12-340
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