Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
NCT ID: NCT05930483
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
640 participants
INTERVENTIONAL
2025-04-08
2028-03-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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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.
¡Vida! program
Participate in ¡Vida! program
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).
¡Vida! program
Participate in ¡Vida! program
¡Vida! Plus [¡Vida! + Experiential Learning (EL)]
Participate in ¡Vida! Plus program
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.
¡Vida! program
Participate in ¡Vida! program
¡Vida! Plus [¡Vida! + Experiential Learning (EL)]
Participate in ¡Vida! Plus program
Health Coaching
Receive health coaching
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.
¡Vida! program
Participate in ¡Vida! program
¡Vida! Plus [¡Vida! + Experiential Learning (EL)]
Participate in ¡Vida! Plus program
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.
¡Vida! program
Participate in ¡Vida! program
¡Vida! Plus [¡Vida! + Experiential Learning (EL)]
Participate in ¡Vida! Plus program
Health Coaching
Receive health coaching
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).
Mailed Toolkits
Receive a mailed toolkit of health items
¡Vida! program
Participate in ¡Vida! program
¡Vida! Plus [¡Vida! + Experiential Learning (EL)]
Participate in ¡Vida! Plus program
Health Coaching
Receive health coaching
Interventions
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Mailed Toolkits
Receive a mailed toolkit of health items
¡Vida! program
Participate in ¡Vida! program
¡Vida! Plus [¡Vida! + Experiential Learning (EL)]
Participate in ¡Vida! Plus program
Health Coaching
Receive health coaching
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Heather Greenlee
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2023-03748
Identifier Type: REGISTRY
Identifier Source: secondary_id
0020054
Identifier Type: OTHER
Identifier Source: secondary_id
RG1123416
Identifier Type: -
Identifier Source: org_study_id
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