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. 2021 May:104:106348.
doi: 10.1016/j.cct.2021.106348. Epub 2021 Mar 8.

Supporting families of children with overweight and obesity to live healthy lifestyles: Design and rationale for the Fitline cluster randomized controlled pediatric practice-based trial

Lori Pbert  1 , Michelle Trivedi  2 , Susan Druker  3 , Jennifer Bram  2 , Barbara Olendzki  3 , Sybil Crawford  4 , Christine Frisard  3 , Victoria Andersen  3 , Molly E Waring  5 , Karen Clements  3 , Kristin Schneider  6 , Alan C Geller  7
Affiliations

Supporting families of children with overweight and obesity to live healthy lifestyles: Design and rationale for the Fitline cluster randomized controlled pediatric practice-based trial

Lori Pbert et al. Contemp Clin Trials. 2021 May.

Abstract

Background: Over a third of preadolescent children with overweight or obesity. The American Academy of Pediatrics (AAP) recommends pediatric providers help families make changes in eating and activity to improve body mass index (BMI). However, implementation is challenging given limited time and referral sources, and family burden to access in-person weight management programs.

Purpose: To describe the design of a National Heart Blood and Lung Institute sponsored cluster randomized controlled pediatric-based trial evaluating the effectiveness of the Fitline pediatric practice-based referral program to reduce BMI and improve diet and physical activity in children with overweight or obesity. Comparison will be made between brief provider intervention plus referral to (1) eight weekly nutritionist-delivered coaching calls with workbook to help families make AAP-recommended lifestyle changes (Fitline-Coaching), vs. (2) the same workbook in eight mailings without coaching (Fitline-Workbook).

Methods: Twenty practices are pair-matched and randomized to one of the two conditions; 494 parents and their children ages 8-12 with a BMI of ≥85th percentile are being recruited. The primary outcome is child BMI; secondary outcomes are child's diet and physical activity at baseline and 6- and 12-months post-baseline. Cost-effectiveness of the two interventions also will be examined.

Conclusion: This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes. If effective, the Fitline program will provide an innovative model for widespread dissemination, setting new standards for weight management care in pediatric practice.

Trial registration: The ClinicalTrials.gov registration number is NCT03143660.

Keywords: Children; Coaching; Group randomized controlled trial; Obesity; Overweight; Pediatric practice.

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Figures

Figure 3.1.
Figure 3.1.
Study Timeline
Figure 3.4.1.a.
Figure 3.4.1.a.
Conceptual Model Based on SCT Theoretical Framework for the Fitline-Coaching Program
See this image and copyright information in PMC

References

    1. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012;307(5):483–490. - PMC - PubMed
    1. The NS, Suchindran C, North KE, Popkin BM, Gordon-Larsen P. Association of adolescent obesity with risk of severe obesity in adulthood. JAMA. 2010;304(18):2042–2047. - PMC - PubMed
    1. Reilly JJ, Kelly J. Long-term impact of overweight and obesity in childhood and adolescence on morbidity and premature mortality in adulthood: systematic review. Int J Obes (Lond). 2011;35(7):891–898. - PubMed
    1. Barlow SE. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007; 120 Suppl 4:S164–192. - PubMed
    1. Polacsek M, Orr J, Letourneau L, et al. Impact of a primary care intervention on physician practice and patient and family behavior: keep ME Healthy---the Maine Youth Overweight Collaborative. Pediatrics. 2009;123 Suppl 5:S258–266. - PubMed

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