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

NCT ID: NCT02482506

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2017-07-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SG-WLP

Self-guided weight loss program

Group Type: OTHER

SG-WLP

Intervention Type: BEHAVIORAL

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.

MF-WLP

Moving Forward Weight Loss Program

Group Type: ACTIVE_COMPARATOR

MF-WLP

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Moving Forward Guided Weight Loss Program; Self-guided Weight Loss Program

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Melinda Stolley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melinda Stolley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

References

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.

Reference Type: DERIVED

PMID: 30982113 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26715447 (View on PubMed)

Other Identifiers

BRE-WL4AA

Identifier Type: -

Identifier Source: org_study_id