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Although the COVID-19 pandemic has increased the importance of digital technology in clinical trial implementation, there is a dearth of literature reporting on challenges and strategies related to multi-site randomized controlled trials (RCTs) among pediatric cancer survivors during the pandemic. This paper discusses challenges faced in the implementation of the NOURISH-T+ trial so far (December 2019-March 2022) and describes adaptations made as a result of these disruptions in the areas of recruitment, data collection, and overall engagement. This reflection is based on a multisite cluster-RCT that aims to examine whether an intervention targeting parents as agents of change to promote healthy eating and physical activity in pediatric cancer survivors, NOURISH-T+ (Nourishing Our Understanding of Role modeling to Improve Support and Health for Healthy Transitions), reduces body mass and improves health behaviors compared to Brief NOURISH-T (Enhanced Usual Care/EUC). The COVID-19 pandemic has created and exacerbated challenges for our trial related to participant recruitment and engagement, technology access and literacy, and data collection and management, as well as COVID-related challenges (e.g., Zoom fatigue). Strategies used to address these challenges might prove helpful in future virtual or hybrid RCTs, including developing trust and rapport with participants, providing support through multiple routes of dissemination, and using data management applications (e.g., REDCap™) for automation and project management. Extra efforts to build families' trust and rapport, offering multiple routes of support, and automating as many tasks as possible are critical to ensuring the continuation of high-quality clinical trials during the COVID-19 pandemic., (© Society of Behavioral Medicine 2022. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Approximately 40-50% of pediatric cancer survivors (PCS) are overweight or obese; increasing their risk for metabolic syndrome and other negative long-term physical health complications. Using our successful pilot trial testing the preliminary feasibility and efficacy of NOURISH for Healthy Transitions (NOURISH-T), we refined our intervention, now NOURISH-T+, and will implement these refinements in this larger, multi-site randomized control trial. Parents of PCS with overweight/obesity (BMI ≥ 85th%ile), age 5-12, ≥6 months off treatment are randomly assigned to the NOURISH-T+ intervention or Enhanced Usual Care (EUC) comparison. Parents in NOURISH-T+ will participate in a 6-session, manualized intervention, with an additional dietician session and 2 PCS sessions, as well as post-intervention booster sessions. EUC consists of a one-time informational session, nationally available brochures and follow-up check-ins. Both study conditions will be conducted remotely via a videoconferencing platform. Parents and PCS will be assessed on anthropometric measures, physical activity (PA) and dietary behaviors at baseline, 3-, 6-, and 12-months post-intervention. We will enroll a diverse group of 260 parents/PCS dyads from four pediatric oncology clinics with the aim of evaluating the efficacy of our intervention across diverse pediatric oncology clinics. Our main aim is to compare the impact of NOURISH-T+ with EUC on PCS BMI z-score. Secondary aims are to compare intervention impact on PCS PA and eating behaviors and parent BMI and behaviors as well as to explore potential moderators of the intervention. Our longer-term goal is to establish a framework for future translation and dissemination of NOURISH-T+., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Latino youth living in rural areas represent an ethnic and geographical minority population at increased risk for obesity and obesity-related complications. We previously modified our child obesity intervention to be a multi-family behavioral intervention, Adaptando Dieta y Acción Para Todos (ADAPT), to better meet the needs of our target population, rural Latino youth with obesity (8-12 years old) and their parents. Recognizing the role of parent stress on obesity, the main goal of this study is to 1) further refine and optimize the original ADAPT multi-family behavioral obesity intervention protocol to include mindfulness parent stress reduction strategies (now called ADAPT+) and then 2) assess the feasibility of ADAPT+ implementation via a small randomized control trial (RCT) with rural Latino families. Two aims guide the study. For Aim 1 we conduct a series of focus groups with stakeholders and parents, and then conduct a one-arm trial with both parents and their children to obtain feedback for further refining each of our eight integrated ADAPT+ sessions. Aim 2 tests the acceptability and feasibility of our intervention with multi-family groups of Latinos in two rural communities over time (pre-intervention, post-intervention, 3-month follow-up) in a randomized pilot trial (ADAPT+ vs. Enhanced Usual Care [EUC] comparison). This study is intended to set the groundwork for a larger clinical trial to test ADAPT+'s efficacy to improve rural Latino families' eating and physical activity behaviors., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Latino migrant farmworkers are at great risk of obesity and its concomitant negative health impacts. Obesity interventions for this underserved, minority population are limited. We expanded upon our prior intervention work in childhood obesity to develop a multi-family, behavioral intervention, ADAPT. We conducted three phases in the development of the ADAPT program: Phase 1, a needs assessment, Phase 2, in-depth focus groups with Latino parents, their children, and stakeholders, and Phase 3, a feasibility and acceptability trial to inform program optimization. Acceptability and feasibility of ADAPT promoting healthier eating and physical activity behaviors was found. Each phase of the project led to implementation changes to ADAPT, resulting in greater intervention optimization. Participants reported key facilitators and barriers to our intervention, expressing great interest in participation. They particularly liked our mindfulness session. We are currently examining the feasibility of integrating mindfulness to optimize ADAPT efficacy.