parents as agents of change (pac) in pediatric weight management the protocol for the pac randomized clinical trial作为变革的父母(pac)在小儿体重管理协议pac随机临床试验.pdf

Ball et al. BMC Pediatrics 2012, 12:114 /1471-2431/12/114 STUDY PROTOCOL Open Access Parents as Agents of Change (PAC) in pediatric weight management: The protocol for the PAC randomized clinical trial 1* 2 3 4 5 6 Geoff D C Ball , Kathryn A Ambler , Rachel A Keaschuk , Rhonda J Rosychuk , Nicholas L Holt , John C Spence , Mary M Jetha7, Arya M Sharma8 and Amanda S Newton9 Abstract Background: There is an urgent need to develop and evaluate weight management interventions to address childhood obesity. Recent research suggests that interventions designed for parents exclusively, which have been named parents as agents of change (PAC) approaches, have yielded positive outcomes for managing pediatric obesity. To date, no research has combined a PAC intervention approach with cognitive behavioural therapy (CBT) to examine whether these combined elements enhance intervention effectiveness. This paper describes the protocol our team is using to examine two PAC-based interventions for pediatric weight management. We hypothesize that children with obesity whose parents complete a CBT-based PAC intervention will achieve greater reductions in adiposity and improvements in cardiometabolic risk factors, lifestyle behaviours, and psychosocial outcomes than children whose parents complete a psycho-education-based PAC intervention (PEP). Methods/Design: This study is a pragmatic, two-armed, parallel, single-blinded, superiority, randomized clinical trial. The primary objective is to examine the differential effects of a CBT-based PAC vs PEP-based PAC intervention on children’s BMI z-score (primary outcome). Secondary objectives are to assess intervention-mediated changes in cardiometabolic, lifest