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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01636258
First received: July 5, 2012
Last updated: August 1, 2013
Last verified: August 2013

July 5, 2012
August 1, 2013
May 2012
October 2012   (final data collection date for primary outcome measure)
Effect of "FRESH" Program on weight loss [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Effect of "FRESH" Program with or without culinary instruction on weight loss [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01636258 on ClinicalTrials.gov Archive Site
To examine correlations between participation in "FRESH" on the lifestyle and health of the participants [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To examine correlations between participation in "FRESH" with cooking instruction on the lifestyle and health of the participants [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)
Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Prediabetes
  • Overweight
  • Behavioral: Stress Management
    Every other week
  • Behavioral: Diet
    Every other week
  • Behavioral: Exercise
    Every week
  • Behavioral: Culinary education
    Every other week
  • 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
    Interventions:
    • Behavioral: Stress Management
    • Behavioral: Diet
    • Behavioral: Exercise
    • Behavioral: Culinary education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
December 2012
October 2012   (final data collection date for primary outcome measure)

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 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:

  1. 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).
  2. 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
  3. Current or past use of oral hypoglycemic agents (including, but not limited to, metformin, rosiglitazone, pioglitazone, glipizide, and glyburide) or insulin
  4. Male gender
  5. History of congestive heart failure
  6. History of renal failure, dialysis, or creatinine greater than 2 mg/dL
  7. 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
  8. 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)
  9. Presence of active cancer
  10. History of coronary artery disease or cerebrovascular disease
  11. History of uncontrolled hypertension
  12. Participation in another lifestyle modification trial
  13. Pregnancy or lactating or planning to be pregnant
  14. Current alcoholism or abuse of recreational drugs
  15. Hospitalization for depression in past 12 months
  16. Travel plans that do not permit full participation or participant lives too far from Health Center to permit full participation
  17. History of bariatric surgery, small bowel resection, or extensive bowel resection
  18. Chronic treatment with systemic steroids
  19. Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
  20. Inability to walk two blocks
  21. 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
  22. Amputation of lower limb for nontraumatic causes
  23. Self report of HIV-positivity or active tuberculosis
  24. Documented history of pulmonary embolus in past six months
  25. Chronic obstructive pulmonary disease that would limit ability to follow the study protocol
  26. 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
  27. Unwilling or uninterested in participating in group lifestyle education sessions
  28. Current regular corticosteroid use
  29. Active polycystic ovarian syndrome
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01636258
12-340
No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Adam M Bernstein, M.D. The Cleveland Clinic
The Cleveland Clinic
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP