Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

BRE-WL4AA Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482506
• Other study ID #: BRE-WL4AA
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: July 2017

Study information

• Verified date: February 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Weight Loss

Intervention

Behavioral:
• MF-WLP
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.
• SG-WLP
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Cancer Institute (NCI), University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	weight in kilograms	6 months
Primary	change in weight	weight in kilograms	12 months