Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MF-WLP
SG-WLP
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring African American, Overweight, Adults
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
SG-WLP
MF-WLP
Arm Description
Self-guided weight loss program
Moving Forward Weight Loss Program
Outcomes
Primary Outcome Measures
Change in weight
weight in kilograms
change in weight
weight in kilograms
Secondary Outcome Measures
Full Information
NCT ID
NCT02482506
First Posted
April 30, 2015
Last Updated
February 25, 2020
Sponsor
Medical College of Wisconsin
Collaborators
University of Chicago, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02482506
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
University of Chicago, National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
African American, Overweight, Adults
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SG-WLP
Arm Type
Other
Arm Description
Self-guided weight loss program
Arm Title
MF-WLP
Arm Type
Active Comparator
Arm Description
Moving Forward Weight Loss Program
Intervention Type
Behavioral
Intervention Name(s)
MF-WLP
Other Intervention Name(s)
Moving Forward Guided Weight Loss Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SG-WLP
Other Intervention Name(s)
Self-guided Weight Loss Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in weight
Description
weight in kilograms
Time Frame
6 months
Title
change in weight
Description
weight in kilograms
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda Stolley, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
30982113
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.
Results Reference
derived
PubMed Identifier
26715447
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.
Results Reference
derived
Learn more about this trial
Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors
We'll reach out to this number within 24 hrs