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

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).

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