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

NCT ID: NCT01636258

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-12-31

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

Conditions

Prediabetes; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A: Control group

These participants will continue to receive their usual care from their primary medical care team.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm B

Arm includes diet instruction, exercise, stress management, and culinary education

Group Type: EXPERIMENTAL

Stress Management

Intervention Type: BEHAVIORAL

Every other week

Diet

Intervention Type: BEHAVIORAL

Every other week

Exercise

Intervention Type: BEHAVIORAL

Every week

Culinary education

Intervention Type: BEHAVIORAL

Every other week

Interventions

Stress Management

Every other week

Intervention Type: BEHAVIORAL

Diet

Every other week

Intervention Type: BEHAVIORAL

Exercise

Every week

Intervention Type: BEHAVIORAL

Culinary education

Every other week

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Linda Libertini

Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam M Bernstein, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Stephanie Tubbs Jones Health Center

East Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24996961 (View on PubMed)

Other Identifiers

12-340

Identifier Type: -

Identifier Source: org_study_id