Lori J Stark1, Stephanie Spear Filigno2, Christopher Bolling3, Megan B Ratcliff4, Jessica C Kichler2, Shannon M Robson5, Stacey L Simon6, Mary Beth McCullough7, Lisa M Clifford8, Cathleen Odar Stough9, Cynthia Zion2, Richard F Ittenbach10. 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. 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. 3. Pediatric Associates, PSC, Crestview Hills, KY. 4. Independent Researcher, Atlanta, GA. 5. Department of Behavioral Health and Nutrition, University of Delaware, Newark, DE. 6. Department of Pediatrics, Division of Pulmonary Medicine, Children's Hospital Colorado, Aurora, CO. 7. Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University. 8. Department of Clinical and Health Psychology, University of Florida, Gainesville, FL. 9. Department of Psychology, University of Cincinnati, Cincinnati, OH. 10. Department of Pediatrics, Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.
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 95th 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.
RCT Entities:
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 95th 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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