Recruiting

Weight Loss Interventions

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT05930483

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

¡Vida! program

¡Vida! Plus [¡Vida! + Experiential Learning (EL)]

Health Coaching

Mailed Toolkits

Study Details

Brief summary:

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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Study ID

NCT05930483

Start date

Apr 8, 2025

Status verified date

Jun, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

640 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm A - Stage 1: ¡Vida!; Stage 2: ¡Vida!

Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled 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.

experimental: Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus

Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled 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).

experimental: Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC)

Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled 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.

experimental: Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus

Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled 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.

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 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled 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.

experimental: Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits

Participants participate in the online ¡Vida! program of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled 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).

Interventions

¡Vida! program

Participate in ¡Vida! program

¡Vida! Plus [¡Vida! + Experiential Learning (EL)]

Participate in ¡Vida! Plus program

Health Coaching

Receive health coaching

Mailed Toolkits

Receive a mailed toolkit of health items

Primary outcome measure

  • Body weight (kg) percent change [ Time Frame: Baseline to 12 months ]

Central Contacts and Locations

Central contacts

Jenny Whitten-Brannon

206-667-5625jwhitten@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Jenny Whitten-Brannon

206-667-5625jwhitten@fredhutch.org

Principal Investigator:

Heather Greenlee

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-06-18.