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: May 21, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Effect of "FRESH" Program on Weight Loss [ Time Frame: Baseline line and final followup visit (at 8-14 weeks) ] [ Designated as safety issue: No ]
    Change in weight measured at baseline and followup (at 8-14 weeks).


Secondary Outcome Measures:
  • Diet - Daily Calorie Intake [ Time Frame: Baseline and final followup visit (at 8-14 weeks) ] [ Designated as safety issue: No ]
    Change in daily caloric intake as measured by online 24-hour recall dietary program

  • Exercise [ Time Frame: Baseline and final followup visits (at 8-14 weeks) ] [ Designated as safety issue: No ]
    Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).

  • Stress [ Time Frame: baseline and followup visit (at 8-14 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and followup visit (at 8-14 weeks) ] [ Designated as safety issue: No ]
    Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).


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
Criteria

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636258

Locations
United States, Ohio
Stephanie Tubbs Jones Health Center
East Cleveland, Ohio, United States, 44112
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Adam M Bernstein, M.D. The Cleveland Clinic
  More Information

No publications provided by The Cleveland Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01636258     History of Changes
Other Study ID Numbers: 12-340
Study First Received: July 5, 2012
Results First Received: October 31, 2013
Last Updated: May 21, 2014
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:
Overweight
Glucose Intolerance
Prediabetic State
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014