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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
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring African American, Overweight, Adults

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    April 30, 2015
    Last Updated
    February 25, 2020
    Sponsor
    Medical College of Wisconsin
    Collaborators
    University of Chicago, National Cancer Institute (NCI)
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    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

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

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