Weight Loss Interventions for Latina Breast Cancer Survivors

This study is looking at different ways to help Latina breast cancer survivors lose weight. Being overweight or obese can affect breast cancer outcomes, and there aren't many effective programs specifically for this group. This trial will test four different weight loss programs: the ¡Vida! program, ¡Vida! Plus (which adds experiential learning), health coaching, and mailed toolkits. Researchers will measure changes in body weight over 12 months to see which interventions are most effective. You may be able to join if you are a Latina woman, at least 18 years old, have been diagnosed with stage I-III breast cancer within the past 5 years, and are at least 60 days past your last cancer treatment. The study is currently unclear on its recruitment status and plans to enroll 640 participants.

Study design
This is an interventional study that will randomly assign participants to one of four different weight loss programs. It is designed as a sequential multiple assignment randomized trial (SMART).
What's involved
You will complete surveys, receive supportive materials like a measuring tape and scale, and may wear an accelerometer. You will also provide a blood sample at the beginning of the study. The interventions last for 12 months.
Compensation
Not stated in the trial record.
Follow-up
Your body weight will be measured at baseline and again at 12 months to see the change.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05930483

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

Recruiting
NAAges 18+InterventionalPrevention
Fred Hutchinson Cancer Center
~640 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:¡Vida! program¡Vida! Plus [¡Vida! + Experiential Learning (EL)]Health CoachingMailed Toolkits

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body weight (kg) percent change
Measured over Baseline to 12 months
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
1 sites across 1 states
Washington1
  • Heather Greenlee · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

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Eligibility criteria

Inclusion

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

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
  • Body weight (kg) percent changeBaseline 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.