A pragmatic trial of a family-centered approach to childhood obesity treatment: Rationale and study design.

Autor: Staiano AE; Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America. Electronic address: amanda.staiano@pbrc.edu., Button AM; Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America., Baker A; American Academy of Pediatrics, 345 Park Blvd., Itasca, IL 60143, United States of America., Beyl R; Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America., Conn AM; University of Rochester Medical Center, 601 Elmwood Ave., Rochester, NY 14642, United States of America., Lima A; Washington University School of Medicine, 660 S. Euclid Ave., Mail Stop 8134-29-2100, St. Louis, MO 63110, United States of America., Lindros J; American Academy of Pediatrics, 345 Park Blvd., Itasca, IL 60143, United States of America., Newton RL Jr; Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America., Stein RI; Washington University School of Medicine, 660 S. Euclid Ave., Mail Stop 8134-29-2100, St. Louis, MO 63110, United States of America., Welch RR; Washington University School of Medicine, 660 S. Euclid Ave., Mail Stop 8134-29-2100, St. Louis, MO 63110, United States of America., Cook S; University of Rochester Medical Center, 601 Elmwood Ave., Rochester, NY 14642, United States of America., Wilfley DE; Washington University School of Medicine, 660 S. Euclid Ave., Mail Stop 8134-29-2100, St. Louis, MO 63110, United States of America.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Mar; Vol. 138, pp. 107459. Date of Electronic Publication: 2024 Jan 24.
DOI: 10.1016/j.cct.2024.107459
Abstrakt: Background: Family-based behavioral treatment (FBT) is an effective intensive health behavior and lifestyle treatment for obesity reduction in children and adolescents, but families have limited access. The purpose of this randomized, pragmatic, comparative effectiveness trial was to examine changes in child relative weight in a 12-month, enhanced standard of care (eSOC) intervention combined with FBT (eSOC+FBT) vs. eSOC alone.
Methods: Children aged 6 to 15 years with obesity, and their primary caregiver, were recruited from primary care clinics. Families were randomized 1:1 to eSOC, a staged approach led by the primary care provider that gradually intensified dependent on a child's response to care and aligns with the American Medical Association guidelines, or the eSOC+FBT arm, which included regular meetings with a health coach for healthy eating, physical activity, positive parenting strategies, and managing social and environmental cues. Both treatments align with the 2023 American Academy of Pediatrics clinical practice guidelines. Assessments occurred at baseline, midpoint (month 6), end-of-intervention (month 12), and follow-up (month 18). Primary outcome was change from baseline to 12 months in child percent overweight (percentage above the median body mass index in the general US population normalized for age and sex). Secondary outcomes were parent weight, child psychosocial factors, heterogeneity of treatment effects, and cardiometabolic risk factors. Exploratory outcomes assessed reach, effectiveness, adoption, implementation, and maintenance.
Conclusion: This pragmatic trial will generate evidence for the comparative effectiveness of implementing two guidelines-based approaches in primary care for obesity reduction in children and adolescents.
Trial Registration: ClinicalTrials.gov Identifier: NCT03843424.
Competing Interests: Declaration of competing interest The authors have no competing interests to disclose.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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