This clinical trial evaluates a mobile weight loss intervention (AYA Connect) for weight management among adolescent and young adult (AYA) cancer survivors. AYA cancer survivors are more likely to face the burden of obesity. An effective intervention could help prevent negative health outcomes in this population. AYA cancer survivors report a need for information and support regarding weight, diet, and exercise, but there are few effective interventions. Research shows that self-regulation behaviors and small distinct changes are successful in weight management. This clinical trial evaluates the AYA Connect application with coaching and self-monitoring activities for weight management among AYA cancer survivors.
Additional locations may be listed on ClinicalTrials.gov for NCT06171945.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of a theory-based, mobile weight loss intervention (AYA Connect) as characterized by the participation rate, accrual rate, and retention rate (i.e., proportion of participants who complete all study measures at 3 and 6-month time points).
SECONDARY OBJECTIVES:
I. Separately for each group (AYA Connect intervention, delayed intervention control), estimate the proportion of participants who complete all study measures at the 3- and 6-month time points.
II. To evaluate the acceptability of the intervention as characterized by ratings of program acceptability and satisfaction at 6 months.
III. To estimate and compare the adherence to daily self-monitoring of weight (wireless scale), activity (Fitbit), and dietary intake (traffic light monitoring) from baseline to 6 months within and between the two groups.
IV. To estimate and compare changes in weight from baseline to 3 and 6 months within and between the two groups.
V. To estimate and compare changes in anthropometric measures (body mass index, body composition, waist circumference) and clinical measures (frailty index, frailty phenotype, blood pressure) from baseline to 3 and 6 months within and between the two groups.
VI. To estimate and compare changes in behavioral measures (dietary intake, physical activity, sedentary behavior) from baseline to 3 and 6 months within and between the two groups.
VII. To estimate and compare changes in psychosocial measures (quality of life, anxiety, perceived stress, global health, cognitive function, weight control strategies) from baseline to 3 and 6 months within and between the two groups.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants monitor their dietary intake and physical activity and receive weekly behavioral lessons and feedback using the AYA Connect mobile application for 12 weeks and attend 12 weekly coaching support discussions over 30-45 minutes each. Participants also weigh themselves daily with a wireless scale and wear an activity tracker.
GROUP II: Participants receive a wireless scale and activity tracker for 12 weeks. Participants then receive a modified version of the Group I intervention.
After completion of study intervention, participants are followed up at 3 and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorCarmina Valle