Trials / Completed
CompletedNCT01267097
The PAC Study: Parents as Agents of Change in Pediatric Weight Management
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- University of Alberta · Academic / Other
- Sex
- All
- Age
- 8 Years – 12 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive Behavioural Therapy (CBT) | 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. |
| BEHAVIORAL | Psycho-Education Program (PEP) | 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. |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2013-09-01
- Completion
- 2014-01-01
- First posted
- 2010-12-24
- Last updated
- 2014-02-20
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT01267097. Inclusion in this directory is not an endorsement.