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; Michelle Trivedi; Susan Druker; Jennifer Bram; Barbara Olendzki; Sybil Crawford; Christine Frisard; Victoria Andersen; Molly E Waring; Karen Clements; Kristin Schneider; Alan C Geller

doi:10.1016/j.cct.2021.106348

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

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

Authors

Affiliations

¹ Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States. Electronic address: lori.pbert@umassmed.edu.
² Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States.
³ Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.
⁴ Graduate School of Nursing, University of Massachusetts Medical School, Worcester, MA, United States.
⁵ Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.
⁶ Department of Psychology, Rosalind Franklin University of Medicine and Science, North Chicago, IL, United States.
⁷ Department of Social and Behavioral Sciences, Harvard School of Public Health, Boston, MA, United States.

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.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural

MeSH terms

Body Mass Index
Child
Health Promotion
Healthy Lifestyle
Humans
Overweight / therapy
Pediatric Obesity* / therapy
Pediatrics*

Associated data

ClinicalTrials.gov/NCT03143660

Abstract

Publication types

MeSH terms

Associated data

Grants and funding