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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02482506
Recruitment Status : Unknown
Verified June 2015 by Melinda Stolley, University of Illinois at Chicago.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2015
Last Update Posted : June 26, 2015
University of Chicago
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Melinda Stolley, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: MF-WLP Behavioral: SG-WLP Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: BRE-WL4AA Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors
Study Start Date : July 2011
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Self-guided weight loss program
Behavioral: 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.
Other Name: Self-guided Weight Loss Program

Active Comparator: MF-WLP
Moving Forward Weight Loss Program
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.
Other Name: Moving Forward Guided Weight Loss Program

Primary Outcome Measures :
  1. Change in weight [ Time Frame: 6 months ]
    weight in kilograms

  2. change in weight [ Time Frame: 12 months ]
    weight in kilograms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02482506

Sponsors and Collaborators
University of Illinois at Chicago
University of Chicago
National Cancer Institute (NCI)
Principal Investigator: Melinda Stolley, PhD University of Illinois at Chicago

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Melinda Stolley, Associate Professor, University of Illinois at Chicago Identifier: NCT02482506     History of Changes
Other Study ID Numbers: BRE-WL4AA
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by Melinda Stolley, University of Illinois at Chicago:
African American

Additional relevant MeSH terms:
Breast Neoplasms
Weight Loss
Neoplasms by Site
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms