Contemporary clinical trials · 2021
'eatNplay' - a rurally-tailored, family-based, telehealth intervention for childhood obesity: Protocol for a mixed-methods randomized newsletter controlled pilot study.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Kummer Allisandra G, Davis-Ajami Mary Lynn, Arce Britney, Hartlieb Kathryn, Dickinson Stephanie, Golzarri-Arroyo Lilian, Olcott Courtney O, Faith Myles, Jayawardene Wasantha P
Аннотация
BACKGROUND: Childhood obesity disproportionately affects rural communities where access to pediatric weight control services is limited. Telehealth may facilitate access to these services.
OBJECTIVE: This paper describes the rationale, curriculum, and methodology for conducting a randomized controlled pilot trial of a rural, family-based, telehealth intervention that aims to improve weight-related behaviors among children, compared to monthly newsletters.
METHODS: A mixed-methods randomized design will randomly assign 44 rural families with one or more children aged 5 to 11 years identified as overweight or obese to an intervention or newsletter control group. The intervention group will attend 'eatNplay' group videoconferencing telehealth sessions, conducted weekly by a registered nurse and a motivational interviewing expert, to discuss diet, exercise, sleep, and peer group influences. The control group will receive newsletters covering these topics. Outcome measures at baseline, 12, and 26 weeks will assess 1) participant engagement and satisfaction with 'eatNplay'; 2) child's BMI, dietary behavior, physical activity, and sleep behavior; and 3) parent/guardians' self-reported beliefs, behaviors, attitudes, perceived stress, and perceived quality of life. Analyses will employ 1) thematic analysis of semi-structured parent/guardian interviews after follow-up to help refine the intervention (e.g., curriculum), and 2) linear mixed models to compare outcomes between groups pre- and post-intervention and reduce bias from unobserved variables. Results of this pilot study could refine methodology for conducting telehealth studies, acceptability of healthcare provider-involved recruitment, interdisciplinary team approach, and addressing childhood obesity in rural communities through telehealth.
OBJECTIVE: This paper describes the rationale, curriculum, and methodology for conducting a randomized controlled pilot trial of a rural, family-based, telehealth intervention that aims to improve weight-related behaviors among children, compared to monthly newsletters.
METHODS: A mixed-methods randomized design will randomly assign 44 rural families with one or more children aged 5 to 11 years identified as overweight or obese to an intervention or newsletter control group. The intervention group will attend 'eatNplay' group videoconferencing telehealth sessions, conducted weekly by a registered nurse and a motivational interviewing expert, to discuss diet, exercise, sleep, and peer group influences. The control group will receive newsletters covering these topics. Outcome measures at baseline, 12, and 26 weeks will assess 1) participant engagement and satisfaction with 'eatNplay'; 2) child's BMI, dietary behavior, physical activity, and sleep behavior; and 3) parent/guardians' self-reported beliefs, behaviors, attitudes, perceived stress, and perceived quality of life. Analyses will employ 1) thematic analysis of semi-structured parent/guardian interviews after follow-up to help refine the intervention (e.g., curriculum), and 2) linear mixed models to compare outcomes between groups pre- and post-intervention and reduce bias from unobserved variables. Results of this pilot study could refine methodology for conducting telehealth studies, acceptability of healthcare provider-involved recruitment, interdisciplinary team approach, and addressing childhood obesity in rural communities through telehealth.