Clinic and Home-Based Behavioral Intervention for Obesity in Preschoolers: A Randomized Trial - 22/11/17

Doi : 10.1016/j.jpeds.2017.09.063

Lori J. Stark, PhD ^1,^* , Stephanie Spear Filigno, PhD ¹, Christopher Bolling, MD ², Megan B. Ratcliff, PhD, MPH ³, Jessica C. Kichler, PhD ¹, Shannon M. Robson, PhD, MPH, RD ⁴, Stacey L. Simon, PhD ⁵, Mary Beth McCullough, PhD ⁶, Lisa M. Clifford, PhD ⁷, Cathleen Odar Stough, PhD ⁸, Cynthia Zion, BS ¹, Richard F. Ittenbach, PhD ⁹
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
² Pediatric Associates, PSC, Crestview Hills, KY
³ Independent Researcher, Atlanta, GA
⁴ Department of Behavioral Health and Nutrition, University of Delaware, Newark, DE
⁵ Department of Pediatrics, Division of Pulmonary Medicine, Children's Hospital Colorado, Aurora, CO
⁶ Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University
⁷ Department of Clinical and Health Psychology, University of Florida, Gainesville, FL
⁸ Department of Psychology, University of Cincinnati, Cincinnati, OH
⁹ Department of Pediatrics, Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH

^*Reprint requests: Lori J. Stark, PhD, Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave MLC 3015, Cincinnati, OH 45229.Division of Behavioral Medicine and Clinical PsychologyCincinnati Children's Hospital Medical Center3333 Burnet Ave MLC 3015CincinnatiOH45229

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Abstract

Objective

To test the hypotheses that an innovative skills-based behavioral family clinic and home-based intervention (LAUNCH) would reduce body mass index z score (BMIz) compared with motivational interviewing and to standard care in preschool-aged children with obesity.

Study design

Randomized controlled trial with children between the ages of 2 and 5 years above the 95^th percentile for body mass index for age and sex recruited from 27 pediatrician offices across 10 recruitment cycles between March 12, 2012 and June 8, 2015. Children were randomized to LAUNCH (an 18-session clinic and home-based behavioral intervention), motivational interviewing (delivered at the same frequency as LAUNCH), or standard care (no formal intervention). Weight and height were measured by assessors blinded to participant assignment. The primary outcome, BMIz at month 6 after adjusting for baseline BMIz, was tested separately comparing LAUNCH with motivational interviewing and LAUNCH with standard care using regression-based analysis of covariance models.

Results

A total of 151 of the 167 children randomized met intent-to-treat criteria and 92% completed the study. Children were 76% White and 57% female, with an average age of 55 months and BMI percentile of 98.57, with no demographic differences between the groups. LAUNCH participants demonstrated a significantly greater decrease in BMIz (mean = −0.32, SD = ±0.33) compared with motivational interviewing (mean = −0.05, SD = ±0.27), P < .001, ω² = 0.74 and compared with standard care (mean = −0.13, SD = ±0.31), P < .004, ω² = 0.75.

Conclusions

In preschool-age children, an intensive 6-month behavioral skills-based intervention is necessary to reduce obesity.

Trial Registration

Clinicaltrials.gov NCT01546727.

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Keywords : behavior family therapy, obesity treatment, preschoolers, motivational interviewing, home visits

Abbreviations : AAP, AEs, BMI, BMIz, LAUNCH

Plan

Methods

Results

Discussion

Supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (R01DK091251), the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH) (UL1 TR001425), and the NIH (T32 DK063929). An independent Data Safety and Monitoring Board participated in protocol review and provided study oversight. The authors declare no conflicts of interest.