Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments mf-wlp, sg-wlp
Sponsor University of Illinois at Chicago
Collaborator University of Chicago
Start date July 2011
End date March 2016
Trial size 240 participants
Trial identifier NCT02482506, BRE-WL4AA

Summary

This is a randomized intervention study to examine the effects of the Moving Forward Guided Weigh Loss Intervention compared to a self-guided weight loss program on BMI and behavioral, biological, and psychosocial outcomes in overweight and obese African American women diagnosed with Stage I, II, or III breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose supportive care
Arm
(Other)
Self-guided weight loss program
sg-wlp Self-guided Weight Loss Program
Control participants will be provided with a 24-week weight loss curriculum; this includes a binder with their personal daily caloric recommendation, all intervention handouts, a copy caloric guidelines and useful weight loss tools. Upon randomization, each control participant will be introduced to the program materials and encouraged to tailor the weight loss program for themselves. The study team will call each control participant once a month during this 6-month program period to check in. In addition, after the follow-up data collection, control participants will receive a one-year membership to the CPD fitness center.
(Active Comparator)
Moving Forward Weight Loss Program
mf-wlp Moving Forward Guided Weight Loss Program
The first meeting each week includes a 60-minute class that addresses health knowledge, attitudes, and self-monitoring of weight, food and physical activity; realistic goal setting; stimulus control; problem solving; cognitive restructuring and relapse prevention. Other class activities include weekly weigh-in; increasing awareness of portions by weighing and measuring foods; creating stimulus control plans for home, car and work; identifying barriers to healthy eating and/or exercise; going on a field trip to a local grocery store to practice reading food labels; creating an eating out management plan; and identifying high risk situations and brainstorming ways to manage them. This meeting also includes a 60-minute exercise class. The second meeting each week is a stand-alone 60-minute exercise class that will incorporate a variety of activities. A one-year CPD fitness club membership and home exercise DVDs will be provided.

Primary Outcomes

Measure
Change in weight
time frame: 6 months
change in weight
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Self-identification as Black or African American (including individuals who are bi-racial but identify themselves as Black or AA) - Female - Stage I, II, and III invasive breast carcinoma - Treatment (surgery, chemotherapy and/or radiation) completed at least 6 months prior to recruitment (ongoing treatment with tamoxifen or AIs is acceptable) - Age 18 or above at time of diagnosis - BMI at least 25 km/m2 - Physically able to participate in a moderate physical activity program as assessed by a screening questionnaire and PCP approval. - Agreeable to random assignment and data collection including blood draw. - Able to attend twic weekly classes for 6 months. Exclusion Criteria: - Plans to move from the community during the study - Medical condition limiting adherence as assessed by PCP - History of significant mental illness - Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study.. - Current/planned use of an FDA-approved or over the counter weight loss medication. - Participation in another structured weight loss program

Additional Information

Official title BRE-WL4AA Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors
Principal investigator Melinda Stolley, PhD
Description This is a randomized study with 300 African American (AA) breast cancer survivors to be conducted in Chicago Park District (CPD) facilities. The study will be based in six predominantly AA communities in Chicago (Roseland, Pullman, Englewood, Chatham, Austin, South Shore, Woodlawn, Calumet Heights, North Lawndale and Grand Crossing). These communities have at least one CPD fitness center, have populations that are at least 90% or more AA and have similar socioeconomic statuses. Fifty AA breast cancer survivors will be recruited from each community (25 treatment/ 25 control). The Moving Forward intervention integrates concepts from Social Cognitive Theory (SCT) and the Socio-Ecological Model (SEM) to promote independent behavior change. SCT suggests that behavior can be explained by the dynamic interaction between behavior, personal factors (e.g., self-efficacy), and the environment (e.g, social support). Self-efficacy is a person's confidence in performing a particular behavior and overcoming barriers to that behavior. A number of studies have supported the mediating role of self-efficacy in making independent health behavior changes. The overall goal of Moving Forward is to make independent changes in health behaviors to promote a healthy weight. The weight loss goal will be consistent with the recommendations of an expert panel at National Institutes of Health (NIH). Dietary goals aimed at producing weight loss, decreasing BC recurrence risk, and improving overall health include 1) a decrease in daily caloric intake (based on weight in pounds X 12 kcal/day with 500-750 calories subtracted to create an energy deficit); 2) a decrease in dietary fat consumption to 20% of total calories; 3) an increase in fruit and vegetable consumption to 7 daily servings; and 4) an increase in fiber to 25 grams per day. For exercise, participants will gradually increase their activity to a minimum of 180 minutes per week at 55-65% maximal heart rate.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Illinois at Chicago.