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

NeuroTherapia, Inc.

Status: Completed

Conditions: Prediabetes; Overweight

Treatments: Behavioral: Diet; Behavioral: Culinary education; Behavioral: Stress Management; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01636258

12-340

Details and patient eligibility

About

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.

Full 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

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Arm A: Control group

No Intervention group

Description:

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

Arm B

Experimental group

Description:

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

Treatment:

Behavioral: Culinary education

Behavioral: Diet

Behavioral: Stress Management

Behavioral: Exercise