Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors
Study Details
Study Description
Brief Summary
This clinical trial evaluates a remotely delivered, culturally tailored weight loss interventions in Latina breast cancer (BC) survivors. Cancer is the leading cause of death among Latinos, and among Latinas, BC is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer BC outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina BC survivors. The development of an adaptive program that provides survivors the support they need, as opposed to what is typically available, is essential to reducing persistent inequities in cancer survivorship.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OUTLINE: This study includes a baseline run-in and randomized stage I and stage II studies.
BASELINE: Participants receive written instructions and website link to an instructional video along with supportive materials including measuring tape, Aria wireless fidelity (WiFi)-enabled scale, and Actigraph accelerometer to be worn for 7 days at baseline. Patients also undergo blood sample collection at baseline.
STAGE I: Eligible participants from the baseline run-in are randomized to arm I or II.
ARM I: Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Patients also undergo blood sample collection on study.
ARM II: Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions on study. Patients also undergo blood sample collection on study.
STAGE II: Participants who achieve >= 2% weight loss (responders) at week 4 will continue their assigned interventions in stage I. Participants who achieve < 2% weight loss (non-responders) at week 4 will be re-randomized to 1 of 4 arms. Participants who were assigned to arm I in stage I are randomized to arm III or IV. Participants who were assigned to arm II in stage I are randomized to arms V or VI.
ARM III: Participants receive interventions as in arm II.
ARM IV: Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions. Patients also undergo blood sample collection on study.
ARM V: Participants receive interventions as in arm IV.
ARM VI: Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions and receive a bag of groceries each month on study. Patients also undergo blood sample collection on study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Baseline (instructions, video, tape, scale, accelerometer) Participants receive written instructions and website link to an instructional video along with supportive materials including measuring tape, Aria WiFi-enabled scale, and Actigraph accelerometer to be worn for 7 days at baseline. Patients also undergo blood sample collection at baseline. |
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
Other: Health Promotion and Education
Receive written instructions and website link to instructional video
Other: Medical Device Usage and Evaluation
Use measuring tape, Aria Wifi-enable scale, and Actigraph accelerometer
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Stage I, Arm I (¡Vida!) Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Patients also undergo blood sample collection on study. |
Behavioral: Behavioral Intervention
Participate in ¡Vida! program
Other Names:
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
Other: Dietary Intervention
Receive dietary modifications
Other Names:
Other: Educational Intervention
Attend online health education sessions
Other Names:
Other: Exercise Intervention
Perform home-based exercise sessions
Other: Internet-Based Intervention
Use Fitbit app
Other: Interview
Ancillary studies
Other: Medical Device Usage and Evaluation
Use Fitbit scale and Fitbit Luxe (or latest model)
Other: Nutritional Intervention
Use Cook for Your Life website
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Stage I, Arm II (¡Vida!, lifestyle sessions) Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions on study. Patients also undergo blood sample collection on study. |
Behavioral: Behavioral Intervention
Participate in ¡Vida! program
Other Names:
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
Other: Dietary Intervention
Receive dietary modifications
Other Names:
Other: Educational Intervention
Attend online health education sessions
Other Names:
Other: Exercise Intervention
Perform home-based exercise sessions
Other: Internet-Based Intervention
Use Fitbit app
Other: Interview
Ancillary studies
Behavioral: Lifestyle Counseling
Attend remote lifestyle health education sessions
Other: Medical Device Usage and Evaluation
Use Fitbit scale and Fitbit Luxe (or latest model)
Other: Nutritional Intervention
Use Cook for Your Life website
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Stage II, Arm III (¡Vida!, lifestyle sessions) Participants receive interventions as in arm II. |
Behavioral: Behavioral Intervention
Participate in ¡Vida! program
Other Names:
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
Other: Dietary Intervention
Receive dietary modifications
Other Names:
Other: Educational Intervention
Attend online health education sessions
Other Names:
Other: Exercise Intervention
Perform home-based exercise sessions
Other: Internet-Based Intervention
Use Fitbit app
Other: Interview
Ancillary studies
Behavioral: Lifestyle Counseling
Attend remote lifestyle health education sessions
Other: Medical Device Usage and Evaluation
Use Fitbit scale and Fitbit Luxe (or latest model)
Other: Nutritional Intervention
Use Cook for Your Life website
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching) Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions. Patients also undergo blood sample collection on study. |
Behavioral: Behavioral Intervention
Participate in ¡Vida! program
Other Names:
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
Other: Dietary Intervention
Receive dietary modifications
Other Names:
Other: Educational Intervention
Attend online health education sessions
Other Names:
Other: Exercise Intervention
Perform home-based exercise sessions
Other: Internet-Based Intervention
Use Fitbit app
Other: Interview
Ancillary studies
Behavioral: Lifestyle Counseling
Attend remote lifestyle health education sessions
Other: Medical Device Usage and Evaluation
Use Fitbit scale and Fitbit Luxe (or latest model)
Other: Nutritional Intervention
Use Cook for Your Life website
Other: Questionnaire Administration
Ancillary studies
Behavioral: Telephone-Based Intervention
Participate in individualized health coaching sessions
|
| Experimental: Stage II, Arm V (¡Vida!, lifestyle sessions, coaching) Participants receive interventions as in arm IV. |
Behavioral: Behavioral Intervention
Participate in ¡Vida! program
Other Names:
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
Other: Dietary Intervention
Receive dietary modifications
Other Names:
Other: Educational Intervention
Attend online health education sessions
Other Names:
Other: Exercise Intervention
Perform home-based exercise sessions
Other: Internet-Based Intervention
Use Fitbit app
Other: Interview
Ancillary studies
Behavioral: Lifestyle Counseling
Attend remote lifestyle health education sessions
Other: Medical Device Usage and Evaluation
Use Fitbit scale and Fitbit Luxe (or latest model)
Other: Nutritional Intervention
Use Cook for Your Life website
Other: Questionnaire Administration
Ancillary studies
Behavioral: Telephone-Based Intervention
Participate in individualized health coaching sessions
|
| Experimental: Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food)) Participants participate in the online ¡Vida! program consisting of 26 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria scale, a Fitbit Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions and receive a bag of groceries each month on study. Patients also undergo blood sample collection on study. |
Behavioral: Behavioral Dietary Intervention
Receive delivered groceries
Behavioral: Behavioral Intervention
Participate in ¡Vida! program
Other Names:
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
Other: Dietary Intervention
Receive dietary modifications
Other Names:
Other: Educational Intervention
Attend online health education sessions
Other Names:
Other: Exercise Intervention
Perform home-based exercise sessions
Other: Internet-Based Intervention
Use Fitbit app
Other: Interview
Ancillary studies
Behavioral: Lifestyle Counseling
Attend remote lifestyle health education sessions
Other: Medical Device Usage and Evaluation
Use Fitbit scale and Fitbit Luxe (or latest model)
Other: Nutritional Intervention
Use Cook for Your Life website
Other: Questionnaire Administration
Ancillary studies
Behavioral: Telephone-Based Intervention
Participate in individualized health coaching sessions
|
Outcome Measures
Primary Outcome Measures
- Body weight (kg) percent change [Up to 12 months]
Will be assessed by the percent of weight loss at month 12 and compared across the four embedded adaptive intervention (EAI) groups using the doubly robust estimator model.
Secondary Outcome Measures
- Body weight (kg) percent change as moderated by baseline characteristics [Up to 12 months]
Will be determined by whether EAI effectiveness is moderated by baseline patient characteristics.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Biologically female
-
Age >= 18 years
-
Self-identifies Hispanic/Latina
-
Fluent in Spanish and/or English
-
Previously diagnosis of stage I-III BC within the past 5 years
-
No evidence of recurrent or metastatic disease
-
60 days post treatment (current endocrine therapy allowed)
-
Body mass index (BMI) >= 30 kg/m^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and WiFi-enabled scale
-
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
-
Physician written clearance for participation in a 12 month weight loss program
-
Willingness to participate in all study activities
-
Access to phone for study contacts
-
Access to internet and smartphone, tablet, or computer to participate in the online program and to be able to sync study WiFi devices
-
Lives within grocery delivery range for online delivery service
-
Successful completion of at-home baseline assessments prior to randomization
Exclusion Criteria:
-
Body mass index (BMI) < 30 kg/m^2
-
Active smoker
-
Diabetic with use of insulin or other hypoglycemic medication
-
Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA
-
Pregnant, breastfeeding, or planning to become pregnant during the study period
-
Use of exogenous hormones for gender affirmation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Heather Greenlee, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1123416
- NCI-2023-03748
- RG1123416
- R01CA270441