Clinical trial NCT02482506: Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors
Official title: BRE-WL4AA Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: African American
Overweight
Adults
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: National Cancer Institute (NCI)
First posted: 2015-06-26
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in weight
timeFrame: 6 months
measure: change in weight
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: Melinda Stolley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Springfield S, Odoms-Young A, Tussing-Humphreys L, Freels S, Stolley M. Adherence to American Cancer Society and American Institute of Cancer Research dietary guidelines in overweight African American breast cancer survivors. J Cancer Surviv. 2019 Apr;13(2):257-268. doi: 10.1007/s11764-019-00748-y. Epub 2019 Apr 13.
citation: Stolley MR, Sharp LK, Fantuzzi G, Arroyo C, Sheean P, Schiffer L, Campbell R, Gerber B. Study design and protocol for moving forward: a weight loss intervention trial for African-American breast cancer survivors. BMC Cancer. 2015 Dec 29;15:1018. doi: 10.1186/s12885-015-2004-4.