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
Trivedi, Michelle K.
Olendzki, Barbara C.
Crawford, Sybil L.
Frisard, Christine F.
Andersen, Victoria A.
Waring, Molly E.
Clements, Karen M.
Geller, Alan C.
UMass Chan AffiliationsPrevention Research Center
Graduate School of Nursing
Department of Pediatrics
Department of Population and Quantitative Health Sciences
Document TypeJournal Article
Group randomized controlled trial
Community Health and Preventive Medicine
Dietetics and Clinical Nutrition
Health Services Administration
Health Services Research
Nutritional and Metabolic Diseases
MetadataShow full item record
AbstractBACKGROUND: 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.
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