¡Mi Vida Saludable!: Results of a Randomized, Controlled, 2 × 2 Factorial Trial of an In-Person and eHealth Diet and Physical Activity Intervention in Latina Breast Cancer Survivors

BACKGROUND: Latina breast cancer survivors experience health disparities. Effective lifestyle interventions are sparse. OBJECTIVE: This trial tested the effectiveness of a culturally tailored diet and physical activity (PA) intervention in Latina breast cancer survivors. DESIGN: Using a 2 × 2 factorial design, women were randomized to receive 4 weekly in-person group sessions; 11 months of eHealth communications, in-person sessions, and eHealth; or control. Follow-up data were collected at months 6 and 12. PARTICIPANTS: Eligibility criteria were self-identification as Latina, post-treatment for early-stage breast cancer, and consuming <5 daily servings of fruits and vegetables (F/V) and/or engaging in <150 min/wk of moderate-to-vigorous PA (MVPA). A total of 167 women from New York City were enrolled from July 2016 to October 2018, with 93.4% retention at 12-month follow-up (n = 156). INTERVENTION: All participants received a Fitbit for self-monitoring and a 1-on-1 health coaching session. In-person group sessions included nutrition and PA education, cooking classes, fitness classes or a grocery store visit, and social activities. The eHealth communications included motivational text messaging, e-mailed newsletters, and study website access. Activities were conducted in Spanish and English. MAIN OUTCOME MEASURES: Primary outcomes were 12-month change in F/V servings/d and energy density of food. Secondary outcomes were 12-month change in MVPA and anthropometry. STATISTICAL ANALYSIS: Outcomes comparing intervention arms with the control were examined using generalized estimating equations. RESULTS: At baseline (n = 167), mean age was 56.7 years; 82.3% had overweight or obesity. At month 12, daily F/V intake for women in the in-person sessions increased by 10% and decreased by 44% for women in the control group, a +96% group difference (P = .01); no other between-group differences were observed. At month 12, women in the control group had a 53% increase in minutes per week of MVPA, and women in the in-person plus eHealth group had a 34% decrease, a -57% group difference (P = .01); no other between-group differences were noted. No changes in energy density or weight between groups were observed. CONCLUSIONS: Women randomized to the in-person ¡Mi Vida Saludable! classes modestly increased F/V intake at 12 months relative to control. Those receiving eHealth communication did not have diet, MVPA, or weight change relative to control. More research is needed to understand how to support Latina breast cancer survivors in making sustained diet and PA changes.