Skip to main content
OpenTrials
Completed

NCT Number: NCT01267097

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Child Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Centre for Weight and Health

Edmonton, Alberta, T5K 0L4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognitive Behavioural Therapy (CBT)

Behavioral

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 names: CBT

Psycho-Education Program (PEP)

Behavioral

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 names: PEP

Primary outcomes

  1. Child BMI Z-score

    Time frame: Pre-intervention

  2. Child BMI Z-score

    Time frame: post-intervention

  3. Child BMI Z-score

    Time frame: 6-months post-intervention

  4. Child BMI Z-score

    Time frame: 12-months post-intervention

Secondary outcomes

  1. Lifestyle behaviours

    Time frame: Pre-intervention

    Nutrition (4-day food records; child and parent) and physical activity (7-day pedometer logs; child and parent) behaviours

  2. Parental stress

    Time frame: Pre-intervention

    Parental stress index (PSI)

  3. Cardiometabolic risk factors

    Time frame: Pre-intervention

    Blood pressure, fasting glucose, fasting insulin, HDL-C, LDL-C, total cholesterol, triglycerides (child only)

  4. Family functioning

    Time frame: Pre-intervention

    Family Adaptability and Cohesion Scale-IV (FACES-IV); completed by parents

  5. Lifestyle behaviours

    Time frame: post-intervention

    Nutrition (4-day food records; child and parent) and physical activity (7-day pedometer logs; child and parent) behaviours

  6. Lifestyle behaviours

    Time frame: 6-months post-intervention

    Nutrition (4-day food records; child and parent) and physical activity (7-day pedometer logs; child and parent) behaviours

  7. Lifestyle behaviours

    Time frame: 12-months post-intervention

    Nutrition (4-day food records; child and parent) and physical activity (7-day pedometer logs; child and parent) behaviours

  8. Parental stress

    Time frame: post-intervention

    Parental stress index (PSI)

  9. Parental stress

    Time frame: 6-months post-intervention

    Parental stress index (PSI)

  10. Parental stress

    Time frame: 12-months post-intervention

    Parental stress index (PSI)

  11. Cardiometabolic risk factors

    Time frame: post-intervention

    Blood pressure, fasting glucose, fasting insulin, HDL-C, LDL-C, total cholesterol, triglycerides (child only)

  12. Cardiometabolic risk factors

    Time frame: 6-months post-intervention

    Blood pressure, fasting glucose, fasting insulin, HDL-C, LDL-C, total cholesterol, triglycerides (child only)

  13. Cardiometabolic risk factors

    Time frame: 12-months post-intervention

    Blood pressure, fasting glucose, fasting insulin, HDL-C, LDL-C, total cholesterol, triglycerides (child only)

  14. Family functioning

    Time frame: post-intervention

    Family Adaptability and Cohesion Scale-IV (FACES-IV); completed by parents

  15. Family functioning

    Time frame: 6-months post-intervention

    Family Adaptability and Cohesion Scale-IV (FACES-IV); completed by parents

  16. Family functioning

    Time frame: 12-months post-intervention

    Family Adaptability and Cohesion Scale-IV (FACES-IV); completed by parents

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • AHS Cancer Control Alberta
  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: PAC

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Dec 24, 2010
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.