The PAC Study: Parents as Agents of Change in Pediatric Weight Management
PAC
2 other identifiers
interventional
63
1 country
1
Brief Summary
The Canadian pediatric obesity epidemic has led to great interest in evaluating weight management care for obese children and families. Investigation is warranted since obesity is linked to risk factors for chronic diseases including type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). Over the past 25 years, many interventions have studied the role of healthy lifestyle behaviours to help obese children achieve and maintain a healthy weight. A contemporary view of pediatric weight management interventions includes parents as a fundamental recipient of treatment. These interventions recognize the influence parents have on the lifestyle behaviours of their children. While such parent-based interventions have helped establish the role of education and behavioural theory in facilitating lifestyle changes, we believe an equally important intervention element is a focus on the role of cognitions in helping to interpret behaviour change and change maintenance. Our study incorporates cognitive behaviour theory (CBT) into an intervention for parents of obese children and compares it to a more traditional modality based on psycho-education (PEP). Hypothesis: Obese 8 - 12 year old children (n=45) whose parents complete a 16-session, group-based, CBT intervention will achieve greater reductions in adiposity as well as improvements in physiological risk factors for T2D, lifestyle behaviours, and psychosocial outcomes at post-intervention as well as 6- and 12-months follow-up versus children (n=45) whose parents complete a 16-session, group-based, psycho-education intervention . Primary Objective: To compare the impact of two weight management interventions (CBT versus PEP) for parents of obese children on child BMI z-score. Secondary Objective: To measure a comprehensive set of physiological, behavioural and psychosocial outcomes in obese children and parents pre- and post-intervention. We expect obese children whose parents complete the CBT intervention will experience greater reductions in BMI z-score vs. children whose parents complete the PEP intervention. We anticipate that improvements in parenting style, family stress, and lifestyle behaviours will be important to improve adiposity, lifestyle behaviours, and risk factors for T2DM and CVD in obese children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Sep 2010
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 16, 2010
CompletedFirst Posted
Study publicly available on registry
December 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFebruary 20, 2014
February 1, 2014
3 years
December 16, 2010
February 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Child BMI Z-score
Pre-intervention
Child BMI Z-score
post-intervention
Child BMI Z-score
6-months post-intervention
Child BMI Z-score
12-months post-intervention
Secondary Outcomes (16)
Lifestyle behaviours
Pre-intervention
Parental stress
Pre-intervention
Cardiometabolic risk factors
Pre-intervention
Family functioning
Pre-intervention
Lifestyle behaviours
post-intervention
- +11 more secondary outcomes
Study Arms (2)
Cognitive Behavioural Therapy (CBT)
EXPERIMENTALGroup-based lifestyle counseling for parents
Psycho-Education Program (PEP)
EXPERIMENTALGroup-based lifestyle counseling for parents
Interventions
Clinical research supports the use of CBT-based interventions in weight management for adults and children. However, the current study will advance the existing knowledge-base by combining CBT with the parents as agents of change approach for pediatric weight management. CBT is a theoretically-based therapy that focuses on the role that cognitive processes play in the maintenance of problem behaviours, mood states, and habits. CBT highlights the relationship between thoughts, feelings and actions, and utilizes techniques involving motivation, goal-setting, problem-solving, and knowledge/skill acquisition that can facilitate sustainable behaviour changes.
PEP is a knowledge-based intervention that is modelled after traditional nutrition and health education programs. Research has demonstrated that knowledge based programs can improve health behaviours and outcomes in overweight and obese populations. In relation to CBT, PEP is a more passive intervention and there is limited focus on active skill building. While PEP does not represent a true control group, its content and delivery are consistent with what many clinicians provide for weight management.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- AHS Cancer Control Albertacollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Pediatric Centre for Weight and Health
Edmonton, Alberta, T5K 0L4, Canada
Related Publications (2)
Ball GD, Mushquash AR, Keaschuk RA, Ambler KA, Newton AS. Using Intervention Mapping to develop the Parents as Agents of Change (PAC(c)) intervention for managing pediatric obesity. BMC Res Notes. 2017 Jan 13;10(1):43. doi: 10.1186/s13104-016-2361-3.
PMID: 28086848DERIVEDBall GD, Ambler KA, Keaschuk RA, Rosychuk RJ, Holt NL, Spence JC, Jetha MM, Sharma AM, Newton AS. Parents as agents of change (PAC) in pediatric weight management: the protocol for the PAC randomized clinical trial. BMC Pediatr. 2012 Aug 6;12:114. doi: 10.1186/1471-2431-12-114.
PMID: 22866998DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoff Ball, PhD, RD
University of Alberta
- PRINCIPAL INVESTIGATOR
Amanda Newton, PhD, RN
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Pediatrics
Study Record Dates
First Submitted
December 16, 2010
First Posted
December 24, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2013
Study Completion
January 1, 2014
Last Updated
February 20, 2014
Record last verified: 2014-02