Status and phase
Conditions
Treatments
About
RATIONALE: A diet and physical activity program followed by a weight-loss maintenance program may help obese black women lose weight. It is not yet known whether a weight-loss program is more effective than a general health education program in helping obese black women lose weight. Weight loss may reduce a person's risk of developing cancer.
PURPOSE: This randomized phase III trial is studying a weight-loss program to see how well it works in helping obese black women lose weight.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Participants are randomized to 1 of 2 intervention arms.
Beginning 1 month after completion of the combined weight-loss intervention, participants undergo a weight-loss maintenance intervention over 12 months. Participants continue their exercise classes twice weekly and receive a copy of the aerobic exercise class videotape for use at home. Prior to each exercise session, participants may share their weight-loss experiences (e.g., successes, struggles) or a motivational or informational story, article, or prayer with other group members. Participants also receive weekly newsletters that include information presented in the original weight-loss intervention, opportunities in the community for physical activity (e.g., ice skating, swimming, or local walks), and further advice on maintaining weight loss. Participants undergo 4 MI sessions over the telephone that address diet, physical activity, and weight-loss maintenance strategies. The MI sessions also provide an opportunity for individualized problem solving.
After completion of the control intervention, participants undergo a control maintenance intervention over 12 months comprising a monthly newsletter on general health topics. After completion of the maintenance intervention, participants undergo 10 intervention sessions and receive the same study-related materials (handouts, food-measuring tools, and pedometers) as in arm I.
Blood samples are collected at baseline, 24 weeks, and 18 months for laboratory biomarker studies. Samples are analyzed for insulin levels by radioimmunoassay, glucose concentrations, and total and free IGF-1, IGFBP-1, IGFBP-2, and IGFBP-3 by enzyme-linked immunoassay.
Participants complete questionnaires at baseline, 24 weeks, and 18 months to assess diet, physical activity, cognitive measures (attitudes, beliefs, and self-efficacy), social support, and environmental measures.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Pre- or perimenopausal
Not pregnant or nursing
Not planning to become pregnant
Not planning to move from the Chicago area during the active and maintenance study interventions (18 months)
No exercise intolerance due to chronic obstructive pulmonary disease (e.g., emphysema, chronic bronchitis, or exercise-induced asthma)
No cancer requiring treatment within the past 5 years, except nonmelanoma skin cancer
No diabetes
No uncontrolled hypertension
None of the following conditions:
No significant mental illness (e.g., schizophrenia or unmedicated bipolar disorder)
No alcohol intake of > 2 drinks per day
No illegal drug use
No laxative abuse (i.e., > twice the recommended dose)
PRIOR CONCURRENT THERAPY:
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal