FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prediabetes Overweight |
Behavioral: Stress Management Behavioral: Diet Behavioral: Exercise Behavioral: Culinary education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study |
- Effect of "FRESH" Program on weight loss [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- To examine correlations between participation in "FRESH" on the lifestyle and health of the participants [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | May 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Behavioral: Stress Management
Every other week
Behavioral: Diet
Every other week
Behavioral: Exercise
Every week
Behavioral: Culinary education
Every other week
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 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
Contacts and Locations| United States, Ohio | |
| Stephanie Tubbs Jones Health Center | |
| East Cleveland, Ohio, United States, 44112 | |
| Principal Investigator: | Adam M Bernstein, M.D. | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT01636258 History of Changes |
| Other Study ID Numbers: | 12-340 |
| Study First Received: | July 5, 2012 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Cleveland Clinic:
|
Prediabetes Overweight African American Women |
Cooking Nutrition Exercise Stress Management |
Additional relevant MeSH terms:
|
Glucose Intolerance Prediabetic State Overweight Hyperglycemia Glucose Metabolism Disorders |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 13, 2013