Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors
BRE-WL4AA Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors
1 other identifier
interventional
240
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jul 2011
Longer than P75 for not_applicable breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFebruary 27, 2020
February 1, 2020
4.7 years
April 30, 2015
February 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in weight
weight in kilograms
6 months
change in weight
weight in kilograms
12 months
Study Arms (2)
SG-WLP
OTHERSelf-guided weight loss program
MF-WLP
ACTIVE COMPARATORMoving Forward Weight Loss Program
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- University of Chicagocollaborator
- National Cancer Institute (NCI)collaborator
Related Publications (2)
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.
PMID: 30982113DERIVEDStolley 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.
PMID: 26715447DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melinda Stolley, PhD
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 30, 2015
First Posted
June 26, 2015
Study Start
July 1, 2011
Primary Completion
March 1, 2016
Study Completion
July 1, 2017
Last Updated
February 27, 2020
Record last verified: 2020-02