Clinical trial NCT01636258: FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)
Official title: Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Overweight
Keywords: Prediabetes
Overweight
African American
Women
Cooking
Nutrition
Exercise
Stress Management
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: Effect of "FRESH" Program on Weight Loss
timeFrame: Baseline line and final followup visit (at 8-14 weeks)
Secondary outcomes:
measure: Diet - Daily Calorie Intake
timeFrame: Baseline and final followup visit (at 8-14 weeks)
measure: Exercise
timeFrame: Baseline and final followup visits (at 8-14 weeks)
measure: Stress
timeFrame: baseline and followup visit (at 8-14 weeks)
measure: Sleep
timeFrame: baseline and followup visit (at 8-14 weeks)
Other outcomes:
Locations:
city: East Cleveland
country: United States
facility: Stephanie Tubbs Jones Health Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Adam M Bernstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernstein AM, Gendy G, Rudd N, Doyle J, Fay S, Moffett K, Morrison S, Bena J, Cotey S, Roizen MF, Golubic M. Management of prediabetes through lifestyle modification in overweight and obese African-American women: the Fitness, Relaxation, and Eating to Stay Healthy (FRESH) randomized controlled trial. Public Health. 2014 Jul;128(7):674-7. doi: 10.1016/j.puhe.2014.04.005. Epub 2014 Jul 2. No abstract available.