¡Mi Vida Saludable! A randomized, controlled, 2 × 2 factorial trial of a diet and physical activity intervention among Latina breast cancer survivors: Study design and methods

Margarita Santiago-Torres, Isobel Contento, Pamela Koch, Wei Yann Tsai, Adam M. Brickman, Ann Ogden Gaffney, Cynthia A. Thomson, Tracy E. Crane, Naxielly Dominguez, Jhack Sepulveda, Amanda M. Marín-Chollom, Rachel Paul, Zaixing Shi, Kathleene T. Ulanday, Christiane Hale, Dawn Hershman, Heather Greenlee

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Background: Most Latina breast cancer survivors do not meet diet and physical activity (PA) guidelines for cancer survivors and effective lifestyle interventions to adopt and maintain these recommendations are limited, especially among underserved populations. Here we describe the design, methods and enrollment of a 2 × 2 factorial-designed trial testing the separate effects of the ¡Mi Vida Saludable! (My Healthy Life!) intervention program on changes in diet and PA behaviors among Latina breast cancer survivors. Methods: Latinas with a history of stage 0-III breast cancer, no evidence of recurrent/metastatic disease, and > 90 days post-treatment were primarily identified via cancer registries and physician referral. Participants were randomized to four arms: 1) 4 weeks of in-person group sessions plus 11 months of eHealth communication, 2) in-person group sessions alone, 3) eHealth alone, or 4) control. All participants received a Fitbit to self-monitor PA. Assessments at baseline, 6 and 12 months include diet, PA, anthropometrics, predictors and mediators of behavior change, psychosocial and quality of life outcomes, and blood draw. Results: Of 884 women screened between January 2016 and September 2018, 27% were eligible. Primary reasons for ineligibility included not being willing/able to participate due to work/life responsibilities, health reasons, or transportation. Of 241 eligible women, 167 completed baseline assessment and enrolled. Conclusions: We successfully enrolled a diverse group of breast cancer survivors representing more than 15 Latin American nationalities to a diet and physical activity trial. If effective, the ¡Mi Vida Saludable! program can be implemented by community groups and medical centers. Trial registration: ClinicalTrials.gov, NCT02780271, registered May 2016.

Original languageEnglish (US)
Article number106524
JournalContemporary Clinical Trials
Volume110
DOIs
StatePublished - Nov 2021

Keywords

  • Breast cancer
  • Cancer survivors
  • Diet
  • Latina or Hispanic
  • Physical activity
  • eHealth

ASJC Scopus subject areas

  • Pharmacology (medical)

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