Grant Number:	1R01CA270111-01A1 Interpret this number
Primary Investigator:	Valle, Carmina
Organization:	Univ Of North Carolina Chapel Hill
Project Title:	Using Tailored Mhealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors
Fiscal Year:	2023

PROJECT ABSTRACT/SUMMARY Survivors of adolescent and young adult cancers (AYAs) are a vulnerable and underserved subgroup of survivors at increased risk for long-term health effects, including obesity, diabetes, cardiovascular disease, additional cancers, and frailty. Furthermore, over half of AYAs already have overweight or obesity and obesogenic lifestyle behaviors are common among AYAs, which exacerbates their cardiometabolic risk. Given that obesity is associated with poorer outcomes in cancer survivors, there is a critical need for weight management interventions—yet, no weight loss interventions have been developed to meet the unique needs of AYAs. Extant research, including our own preliminary data, indicate that AYAs prefer tailored interventions (both with respect to developmental stage and cancer context) that are delivered remotely via website or app. Thus, we propose to develop a 6-month mHealth weight management intervention designed specifically for AYA cancer survivors and test its efficacy in a randomized controlled trial. The intervention will be rooted in self-determination theory in order to bolster intrinsic motivation for health behavior change by enhancing perceived competence, relatedness, and autonomy. It will include evidence-based behavioral weight loss strategies adapted for AYA survivors (e.g., simplified dietary self-monitoring, adaptive goal-setting, tailored feedback on progress) as well as personalized dietary and physical activity goals. The intervention will be paired with digital monitoring tools (wireless scale and activity tracker), as well as access to a closed Facebook group to foster peer support. AYA survivors nationwide (N=240, diagnosed between ages 15-39 [current age 18-39], posttreatment, body mass index [BMI] 25-50kg/m2) will be randomized to one of two arms: 1) mHealth intervention as described above, or 2) self-guided (digital tools + health education + Facebook). Randomization will be stratified by BMI, sex, and race/ethnicity. Assessments will occur at 0, 3, 6, and 12 months. Percent weight change at 6 months (primary outcome) will be assessed using a remote collection protocol via video weigh-in and wireless scale to facilitate enhanced reach across the US. Secondary outcomes in the full sample include frailty (frailty index), objectively measured physical activity (ActiGraph GT9X Link), dietary intake (ASA24), and quality of life (SF-36), as well as questionnaires assessing hypothesized psychosocial mediators targeted by the intervention. A subsample of participants (n=80) will complete in-person visits at each clinical site at 0, 6, and 12 months to assess changes in body composition, waist circumference, frailty, and biomarkers of aging and cardiometabolic disease. We hypothesize that compared to the self-guided arm, AYAs in the intervention arm will manifest greater percent weight loss at 6 months and better maintenance of weight loss from 6 to 12 months. We also will examine the psychological and behavioral mechanisms of action to inform future optimization efforts, and explore demographic and clinical- related moderators of intervention response. Our findings will accelerate the development of effective remotely- delivered mHealth weight loss interventions to improve outcomes and reduce the burden of morbidity in AYAs.





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