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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT05930483
Status
Recruiting
Apply to this trial

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 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ¡Vida! program — BEHAVIORAL
    Participate in ¡Vida! program
  • ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] — BEHAVIORAL
    Participate in ¡Vida! Plus program
  • Health Coaching — BEHAVIORAL
    Receive health coaching
  • Mailed Toolkits — BEHAVIORAL
    Receive a mailed toolkit of health items

Study Details

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.

Key Dates

Start date
Apr 8, 2025
Status verified
Dec 2025
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
640 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Experimental: 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).
  • Experimental: 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.
  • Experimental: 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.
  • 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 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.
  • Experimental: 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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Jenny Whitten-Brannon
[email protected]
206-667-5625
Heather Greenlee (PRINCIPAL_INVESTIGATOR)

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