RecruitingRecruiting
Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
NCT05930483 · Fred Hutchinson Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study
About this study
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, 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).
Eligibility criteria
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 design
Enrollment target: 640 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-08
Estimated completion: 2028-03-01
Last updated: 2026-06-18
Interventions
Behavioral: ¡Vida! programBehavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]Behavioral: Health CoachingBehavioral: Mailed Toolkits
Primary outcomes
- • Body weight (kg) percent change (Baseline to 12 months)
Sponsor
Fred Hutchinson Cancer Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactJenny Whitten-Brannon · contact · jwhitten@fredhutch.org · 206-667-5625
InvestigatorHeather Greenlee · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (1)
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States