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

NCT01636258 | Completed Results

• 1 other identifier: 12-340
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes; Overweight

Keywords

Prediabetes; Overweight; African American; Women; Cooking; Nutrition; Exercise; Stress Management

Outcome Measures

Primary Outcomes (1)

• Effect of "FRESH" Program on Weight Loss

  Change in weight measured at baseline and followup (at 8-14 weeks).

  Baseline line and final followup visit (at 8-14 weeks)

Secondary Outcomes (4)

• Diet - Daily Calorie Intake

  Baseline and final followup visit (at 8-14 weeks)

• Exercise

  Baseline and final followup visits (at 8-14 weeks)

• Stress

  baseline and followup visit (at 8-14 weeks)

• Sleep

  baseline and followup visit (at 8-14 weeks)

Study Arms (2)

Arm A: Control group

NO INTERVENTION

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

Arm B

EXPERIMENTAL

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

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

Interventions

Stress Management BEHAVIORAL

Every other week

Arm B

Diet BEHAVIORAL

Every other week

Arm B

Exercise BEHAVIORAL

Every week

Arm B

Culinary education BEHAVIORAL

Every other week

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participants must:
• Be capable of giving informed consent
• Understand and voluntarily sign the informed consent form.
• Be females at least 18 years of age and identify themselves as African-American
• 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)
• Have a body mass index (BMI, defined as weight in kilograms divided by height in meters squared) greater than or equal to 25

You may not qualify if:

• 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).
• 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
• Current or past use of oral hypoglycemic agents (including, but not limited to, metformin, rosiglitazone, pioglitazone, glipizide, and glyburide) or insulin
• Male gender
• History of congestive heart failure
• History of renal failure, dialysis, or creatinine greater than 2 mg/dL
• 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
• 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)
• Presence of active cancer
• History of coronary artery disease or cerebrovascular disease
• History of uncontrolled hypertension
• Participation in another lifestyle modification trial
• Pregnancy or lactating or planning to be pregnant
• Current alcoholism or abuse of recreational drugs
• Hospitalization for depression in past 12 months

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Stephanie Tubbs Jones Health Center

East Cleveland, Ohio, 44112, United States

Location

Related Publications (1)

• 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.

  PMID: 24996961 DERIVED

MeSH Terms

Conditions

Prediabetic State; Overweight; Motor Activity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Adam M. Bernstein MD
• Organization: The Cleveland Clinic

bernsta2@ccf.org

216-448-8538

Study Officials

• Adam M Bernstein, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 10, 2022
• Results First Posted: June 9, 2014

Record last verified: 2022-05

Locations

US (1)