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
Department of Population and Quantitative Health Sciences; Department of Pediatrics; Graduate School of Nursing; UMass Worcester Prevention Research Center
Community Health and Preventive Medicine | Dietetics and Clinical Nutrition | Health Services Administration | Health Services Research | Nutritional and Metabolic Diseases | Pediatrics | Preventive Medicine | Telemedicine
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.
Children, Coaching, Group randomized controlled trial, Obesity, Overweight, Pediatric practice
DOI of Published Version
Pbert L, Trivedi M, Druker S, Bram J, Olendzki B, Crawford S, Frisard C, Andersen V, Waring ME, Clements K, Schneider K, Geller AC. 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 Mar 8;104:106348. doi: 10.1016/j.cct.2021.106348. Epub ahead of print. PMID: 33706002. Link to article on publisher's site
Contemporary clinical trials
Pbert L, Trivedi MK, Druker S, Bram J, Olendzki BC, Crawford SL, Frisard CF, Andersen VA, Waring ME, Clements KM, Schneider K, Geller AC. (2021). 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. University of Massachusetts Medical School Faculty Publications. https://doi.org/10.1016/j.cct.2021.106348. Retrieved from https://escholarship.umassmed.edu/faculty_pubs/1953