The PAC Study: Parents as Agents of Change in Pediatric Weight Management

This study has been completed.
Sponsor:
Collaborators:
AHS Cancer Control Alberta
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Geoff Ball, University of Alberta
ClinicalTrials.gov Identifier:
NCT01267097
First received: December 16, 2010
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Obesity
Child
Behavioral: Cognitive Behavioural Therapy (CBT)
Behavioral: Psycho-Education Program (PEP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The PAC Study: Parents as Agents of Change in Pediatric Weight Management

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Child BMI Z-score [ Time Frame: Pre-intervention ] [ Designated as safety issue: No ]
  • Child BMI Z-score [ Time Frame: post-intervention ] [ Designated as safety issue: No ]
  • Child BMI Z-score [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
  • Child BMI Z-score [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lifestyle behaviours [ Time Frame: Pre-intervention ] [ Designated as safety issue: No ]
    Nutrition (4-day food records; child and parent) and physical activity (7-day pedometer logs; child and parent) behaviours

  • Parental stress [ Time Frame: Pre-intervention ] [ Designated as safety issue: No ]
    Parental stress index (PSI)

  • Cardiometabolic risk factors [ Time Frame: Pre-intervention ] [ Designated as safety issue: No ]
    Blood pressure, fasting glucose, fasting insulin, HDL-C, LDL-C, total cholesterol, triglycerides (child only)

  • Family functioning [ Time Frame: Pre-intervention ] [ Designated as safety issue: No ]
    Family Adaptability and Cohesion Scale-IV (FACES-IV); completed by parents

  • Lifestyle behaviours [ Time Frame: post-intervention ] [ Designated as safety issue: No ]
    Nutrition (4-day food records; child and parent) and physical activity (7-day pedometer logs; child and parent) behaviours

  • Lifestyle behaviours [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
    Nutrition (4-day food records; child and parent) and physical activity (7-day pedometer logs; child and parent) behaviours

  • Lifestyle behaviours [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
    Nutrition (4-day food records; child and parent) and physical activity (7-day pedometer logs; child and parent) behaviours

  • Parental stress [ Time Frame: post-intervention ] [ Designated as safety issue: No ]
    Parental stress index (PSI)

  • Parental stress [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
    Parental stress index (PSI)

  • Parental stress [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
    Parental stress index (PSI)

  • Cardiometabolic risk factors [ Time Frame: post-intervention ] [ Designated as safety issue: No ]
    Blood pressure, fasting glucose, fasting insulin, HDL-C, LDL-C, total cholesterol, triglycerides (child only)

  • Cardiometabolic risk factors [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
    Blood pressure, fasting glucose, fasting insulin, HDL-C, LDL-C, total cholesterol, triglycerides (child only)

  • Cardiometabolic risk factors [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
    Blood pressure, fasting glucose, fasting insulin, HDL-C, LDL-C, total cholesterol, triglycerides (child only)

  • Family functioning [ Time Frame: post-intervention ] [ Designated as safety issue: No ]
    Family Adaptability and Cohesion Scale-IV (FACES-IV); completed by parents

  • Family functioning [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
    Family Adaptability and Cohesion Scale-IV (FACES-IV); completed by parents

  • Family functioning [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
    Family Adaptability and Cohesion Scale-IV (FACES-IV); completed by parents


Enrollment: 63
Study Start Date: September 2010
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioural Therapy (CBT)
Group-based lifestyle counseling for parents
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.
Other Name: CBT
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.
Other Name: PEP
Experimental: Psycho-Education Program (PEP)
Group-based lifestyle counseling for parents
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.
Other Name: CBT
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.
Other Name: PEP

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Boys and girls (n = 90) between 8 - 12 years of age with a sex- and age-specific BMI ≥95th percentile are eligible for this study. Children are referred to the Pediatric Centre for Weight and Health (PCWH) at the Stollery Children's Hospital (SCH) (Edmonton, AB, Canada) only if their BMI percentile meets or exceeds this threshold. At least one parent/guardian per family is required to participate in one of the two group-based interventions as agents of change for their family.

Exclusion Criteria: Obese children referred to the PCWH <8 years old will be referred to an outpatient dietitian for nutrition counselling; obese boys and girls >12 years old will be eligible for other weight management interventions at the PCWH. Children who do not have a parent/guardian interested in participating or possess an age- and sex-specific BMI <95th percentile will be ineligible. Children diagnosed with an endocrine disorder (i.e., Polycystic Ovarian Syndrome, Prader-Willi Syndrome, hypothyroidism) will be referred to the Endocrine Clinic at the SCH. Parents or children who are identified at screening as having severe mental health conditions or psychosocial circumstances that could limit their ability to participate in the interventions will be referred to appropriate agencies and services. Impaired ability to participate in either intervention may include substantial difficulties in attendance or implementing changes at home. Referral services may include psychological/psychiatric services, welfare services, and private nutrition or exercise counselling. Dr. Rachel Keaschuk (PCWH Psychologist and Co-I) will perform psychological interviews (75 - 90 minutes) with all families to determine family appropriateness and will lead family discussions regarding referral services (if indicated).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267097

Locations
Canada, Alberta
Pediatric Centre for Weight and Health
Edmonton, Alberta, Canada, T5K 0L4
Sponsors and Collaborators
University of Alberta
AHS Cancer Control Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Geoff Ball, PhD, RD University of Alberta
Principal Investigator: Amanda Newton, PhD, RN University of Alberta
  More Information

Additional Information:
No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geoff Ball, Associate Professor, Department of Pediatrics, University of Alberta
ClinicalTrials.gov Identifier: NCT01267097     History of Changes
Other Study ID Numbers: PCWH01-2009, CIHR-MSH83715
Study First Received: December 16, 2010
Last Updated: February 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Pediatric Obesity
Treatment
Cognitive Behavioural Therapy
Psychoeducation
Canada

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014