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Contemp Clin Trials. 2017 Jan;52:10-19. doi: 10.1016/j.cct.2016.10.007. Epub 2016 Oct 21.

Learning about Activity and Understanding Nutrition for Child Health (LAUNCH): Rationale, design, and implementation of a randomized clinical trial of a family-based pediatric weight management program for preschoolers.

Author information

1
Department of Pediatrics, Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, United States. Electronic address: Lori.Stark@cchmc.org.
2
Department of Pediatrics, Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, United States.
3
Pediatric Associates, PSC, Crestview Hills, KY, United States.
4
Independent Researcher, Atlanta, GA, United States.
5
Department of Behavioral Health and Nutrition, University of Delaware, Newark, DE, United States.
6
Department of Pediatrics, Division of Pulmonary Medicine, Children's Hospital Colorado, Aurora, CO, United States.
7
Department of Clinical and Health Psychology, University of Florida, United States.
8
Department of Pediatrics, Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, United States.

Abstract

Obesity affects nearly 2 million preschool age children in the United States and is not abating. However, research on interventions for already obese preschoolers is limited. To address this significant gap in the literature, we developed an intervention targeting obesity reduction in 2 to 5year olds, Learning about Activity and Understanding Nutrition for Child Health (LAUNCH). This paper describes the rationale, design, participant enrollment, and implementation of a 3-arm randomized, parallel-group clinical trial comparing LAUNCH to a motivational-interviewing intervention (MI) and standard care (STC), respectively. Whereas LAUNCH was designed as a skills based intervention, MI focused on addressing the guardian's motivation to make changes in diet and activity and providing tools to do so at the guardian's level of readiness to implement changes. Child body mass index z-score was the primary outcome, assessed at pretreatment, posttreatment (Month 6), and 6 and 12month follow-ups (Months 12 and 18). Mechanisms of weight change (e.g., dietary intake, physical activity) and environmental factors associated with weight (e.g., foods available in the home, caregiver diet) were also assessed. This study is unique because it is one of the few randomized controlled trials to examine a developmentally informed, clinic and home skills based behavioral family intervention for preschoolers who are already obese. Being obese during the preschool years increases the likelihood of remaining obese as an adult and is associated with serious health conditions; if this intervention is successful, it has the potential to change the health trajectories for young children with obesity.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01546727.

PMID:
27777128
DOI:
10.1016/j.cct.2016.10.007
[Indexed for MEDLINE]

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