title: Parents as agents of change (PAC) in pediatric weight management: the protocol for the PAC randomized clinical trial.
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
  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, lifestyle, and psychosocial variables in children and parents. Both interventions are similar in frequency of contact, session duration, group facilitation, lifestyle behaviour goals, and educational content. However, the interventions differ insofar as the CBT-based intervention incorporates theory-based concepts to help parents link their thoughts, feelings, and behaviours; these cognitive activities are enabled by group leaders who possess formal training in CBT. Mothers and fathers of children (8-12 years of age; BMI ≥85th percentile) are eligible to participate if they are proficient in English (written and spoken) and agree for at least one parent to attend group-based sessions on a weekly basis. Anthropometry, cardiometabolic risk factors, lifestyle behaviours, and psychosocial health of children and parents are assessed at pre-intervention, post-intervention, 6-, and 12-months follow-up.
  
  
  CONCLUSIONS
  This study is designed to extend findings from earlier efficacy studies and provide data on the effect of a CBT-based PAC intervention for managing pediatric obesity in a real-world, outpatient clinical setting.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01267097.
authors.affiliation: 8B, Pediatric Centre for Weight and Health, Edmonton General Continuing Care Centre, 11111 Jasper Ave, Edmonton, AB, CANADA, T5K0L4. gdball@ualberta.ca
authors.forename: Geoff D C
authors.initials: GD
authors.lastname: Ball
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Ambler
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Keaschuk
authors.forename: Rhonda J
authors.initials: RJ
authors.lastname: Rosychuk
authors.forename: Nicholas L
authors.initials: NL
authors.lastname: Holt
authors.forename: John C
authors.initials: JC
authors.lastname: Spence
authors.forename: Mary M
authors.initials: MM
authors.lastname: Jetha
authors.forename: Arya M
authors.initials: AM
authors.lastname: Sharma
authors.forename: Amanda S
authors.initials: AS
authors.lastname: Newton
mesh_terms: D015992:Body Mass Index; D002648:Child; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D016014:Linear Models; D008297:Male; D015999:Multivariate Analysis; D009765:Obesity / Q000628:therapy*; D010290:Parents / Q000193:education* / Q000523:psychology; D016037:Single-Blind Method; D016896:Treatment Outcome; D061217:Weight Reduction Programs / Q000379:methods*