A digital health intervention to improve nutrition and physical activity in breast cancer survivors: Rationale and design of the Cook and Move for Your Life pilot and feasibility randomized controlled trial.

BACKGROUND: The design of a randomized pilot trial evaluating the feasibility of two doses of a digital health intervention promoting changes in nutrition and physical activity in breast cancer (BC) survivors is described. METHODS: Eligible women were adults with history of early-stage breast cancer and > 60 days post-treatment, consumed <5 servings/day of fruits/vegetables and/or engaged in <150 min/week of aerobic moderate-to-vigorous physical activity, and had internet access. Participants were randomized to 6 months of either a "low" (1 session) or "high" (12 sessions) dose digital health intervention. Zoom-delivered sessions focused on improving diet and physical activity through didactic and experiential classes delivered by a registered dietitian, chef, exercise physiologist, and culinary educator. All study participants received weekly motivational texts, a Fitbit, and study website access. Diet, accelerometry, anthropometric, psychosocial, and biospecimen data were collected remotely at baseline and six months. Primary outcome was feasibility measured via accrual rate, adherence, retention, and acceptability. RESULTS: Recruitment began in December 2019, was suspended in March 2020 due to the COVID-19 pandemic, resumed September 2020, and concluded in January 2021. Women were identified from the local BC registry and flyers posted in the oncology clinic. Of 929 women recruited, 321 completed the screening assessment, and of these, 138 were eligible. A total of 74 women were enrolled and randomized to the study. CONCLUSION: BC survivors were successfully enrolled in a digital health nutrition and physical activity intervention. If feasible, this intervention will be tested in larger and more diverse populations of cancer survivors. TRIAL REGISTRATION: ClinicalTrials.govNCT04200482.

Group Randomized Trial of Healthy Eating and Gardening Intervention in Navajo Elementary Schools (Yéego!)

Introduction : Few healthy eating, school-based interventions have been rigorously evaluated in American Indian communities. Gardening and healthy eating are priorities in the Navajo Nation. Collaborations between researchers and local partners supported the design and implementation of this project. Study Design : The Yéego! Healthy Eating and Gardening Study was a group randomized controlled trial to evaluate a school-based healthy eating and gardening intervention in six schools on the Navajo Nation. Schools were randomized 1:2 to intervention or comparison. Setting/Participants : The Shiprock and Tsaile/Chinle areas on the Navajo Nation were selected. Elementary schools were screened for eligibility. All students in 3rd and 4th grades were invited to participate in the assessments. Intervention : Delivered during one school year in the intervention schools, the intervention included culturally relevant nutrition and gardening curriculum and a school garden. Main outcome measures : Student self-efficacy for eating fruits and vegetables (F&V) and for gardening, and student healthy foods score from a modified Alternative Healthy Eating Index were assessed in 3rd and 4th graders at the beginning and end of a school year affected by the COVID pandemic. Primary analyses used repeated measures linear mixed models accounting for students nested within schools to estimate the intervention effect and 95% Confidence Intervals (CI). Results : Student self-efficacy for eating F&V was 0.22 higher (95%CI 0.04,0.41) in the intervention compared with comparison schools Although the student healthy foods score increased in the intervention schools, 2.0 (95%CI 0.4,3.6), the differential change was modest 1.7 (95%CI -0.3,3.7). The self-efficacy to grow F&V in the school garden increased among those in the intervention schools (OR=1.92 95%CI 1.02,3.63), but not significantly more than in the comparison schools. (OR=1.29 95%CI 0.60,2.81). Conclusions : The intervention was efficacious in improving self-efficacy for eating F&V among 3rd and 4th grade students over a school year. The findings warrant further evaluation of the intervention in larger group randomized trials with schools in Navajo communities.