Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial

Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study

This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second leading cause of cancer death among women in the US. There are population differences in breast cancer mortality, based on specific risk factors, including obesity. Cancer is the leading cause of death among Latinos, and among Latinas, breast cancer is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer breast cancer outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina breast cancer survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, to improve breast cancer survivorship.

Study Overview

• Status: Recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
• Intervention / Treatment: Behavioral: ¡Vida! program; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]; Behavioral: Health Coaching; Behavioral: Mailed Toolkits

Detailed Description

OUTLINE: This sequential multiple assignment randomized trial (SMART) will test four different community-aligned 12-month adaptive weight loss interventions.

BASELINE: Participants receive written instructions and website link to complete surveys along with supportive materials including a measuring tape, Aria Bluetooth-enabled scale, and may receive an Actigraph accelerometer to be worn for 7 days at baseline. Participants also undergo blood sample collection at baseline.

STAGE ONE: Eligible participants from the baseline run-in are randomized to participate in Stage One. In Stage One, participants are randomized to one of two groups: ¡Vida! or ¡Vida! Plus.

STAGE TWO: Percent weight loss is measured at week 8. Women who lose ≥2% of their body weight at week 8 will be considered "Responders" and will continue with their original randomization assignment in Stage Two.

Women in the Stage One ¡Vida! group who lose <2% of their body weight will be re-randomized in Stage Two to receive either ¡Vida! Plus or ¡Vida! Plus + health coaching (HC). Women in the Stage One ¡Vida! Plus group who lose <2% of their body weight will be re-randomized in Stage Two to receive either ¡Vida! Plus + HC or ¡Vida! Plus + HC + mailed toolkits (MT).

• Study Type: Interventional
• Enrollment (Estimated): 640
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenny Whitten-Brannon; Phone Number: 206-667-5625; Email: jwhitten@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Principal Investigator: Heather Greenlee
      • Contact: Jenny Whitten-Brannon; Phone Number: 206-667-5625; Email: jwhitten@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Biologically female
• Age >= 18 years
• Self-identifies Hispanic/Latina
• Able to read and write in Spanish and/or English
• Previous diagnosis of stage I-III BC within the past 5 years
• No evidence of current, recurrent, or metastatic disease
• 60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4/6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial)
• Body mass index (BMI) >= 27 kg/m^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Willingness to participate in all study activities
• Access to phone for study contacts
• Access to internet to participate in the online program and to be able to sync study devices
• Successful completion of at-home baseline assessments prior to randomization

Exclusion Criteria:

• Body mass index (BMI) < 27 kg/m^2 at time of baseline data collection
• Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)
• Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline
• Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine [T-DM1], trastuzumab deruxtecan [T-DXd])
• 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
• For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months
• For stool sample collection only: Presence of self-reported ileostomy or colostomy
• For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)
• Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation.
• Concurrent enrollment in another weight loss or physical activity trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A - Stage 1: ¡Vida!; Stage 2: ¡Vida!; Participants participate in the online ¡Vida! program consisting of 24 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 Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! in Stage 1 and were responders (≥2% weight loss at 8 weeks). In Stage 2, responders receive additional ¡Vida! intervention programming.	Behavioral: ¡Vida! program; Participate in ¡Vida! program; Other Names: Behavioral Intervention
Experimental: Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus; Participants participate in the online ¡Vida! program consisting of 24 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 Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (<2% weight loss at 8 weeks). In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL).	Behavioral: ¡Vida! program; Participate in ¡Vida! program; Other Names: Behavioral Intervention; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]; Participate in ¡Vida! Plus program
Experimental: Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC); Participants participate in the online ¡Vida! program consisting of 24 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 Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (<2% weight loss at 8 weeks). In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL), and also receive health coaching.	Behavioral: ¡Vida! program; Participate in ¡Vida! program; Other Names: Behavioral Intervention; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]; Participate in ¡Vida! Plus program; Behavioral: Health Coaching; Receive health coaching
Experimental: Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus; Participants participate in the online ¡Vida! program consisting of 24 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 Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were responders (≥2% weight loss at 8 weeks). In Stage 2, responders receive additional ¡Vida! Plus intervention programming.	Behavioral: ¡Vida! program; Participate in ¡Vida! program; Other Names: Behavioral Intervention; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]; Participate in ¡Vida! Plus program
Experimental: Arm E - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC); Participants participate in the online ¡Vida! program consisting of 24 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 Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were non-responders (<2% weight loss at 8 weeks). In Stage 2, non-responders receive additional ¡Vida! Plus intervention programming, and also receive health coaching.	Behavioral: ¡Vida! program; Participate in ¡Vida! program; Other Names: Behavioral Intervention; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]; Participate in ¡Vida! Plus program; Behavioral: Health Coaching; Receive health coaching
Experimental: Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits; Participants participate in the online ¡Vida! program consisting of 24 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 Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions, and receive a mailed toolkit of health items twice on study. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were non-responders (<2% weight loss at 8 weeks). In Stage 2, non-responders receive additional ¡Vida! Plus intervention programming, and also receive health coaching (HC) as well as mailed toolkits (MT).	Behavioral: ¡Vida! program; Participate in ¡Vida! program; Other Names: Behavioral Intervention; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]; Participate in ¡Vida! Plus program; Behavioral: Health Coaching; Receive health coaching; Behavioral: Mailed Toolkits; Receive a mailed toolkit of health items

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight (kg) percent change	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.	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight (kg) percent change as moderated by baseline characteristics	Will be determined by whether EAI effectiveness is moderated by baseline patient characteristics.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heather Greenlee, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Body Weight; Body Weight Changes; Skin Diseases; Breast Diseases; Weight Loss; Breast Neoplasms; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: RG1123416 (Fred Hutch/University of Washington Cancer Consortium); NCI-2023-03748 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA270441 (U.S. NIH Grant/Contract); 0020054 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No