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ObesityPACNCT01267097

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

A study testing Cognitive Behavioural Therapy (CBT) and Psycho-Education Program (PEP) in people with Obesity and Child, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Child
What is being tested?
Cognitive Behavioural Therapy (CBT) and Psycho-Education Program (PEP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteCanada
Study dates
Sep 2010to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Pediatric Centre for Weight and Health

    Edmonton, Alberta, T5K 0L4

Other trials in Canada

About this study

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 .

Read more

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
Obesity, Child
Being tested
Cognitive Behavioural Therapy (CBT), Psycho-Education Program (PEP)
Keywords
Pediatric Obesity, Treatment, Cognitive Behavioural Therapy, Psychoeducation, Canada
Medical subject headings
Obesity, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioural Therapy (CBT)Behavioural

    Also called 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.

  • Psycho-Education Program (PEP)Behavioural

    Also called 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.

Study groups in NCT01267097
Study groupRoleWhat they receive
Cognitive Behavioural Therapy (CBT)ExperimentalGroup-based lifestyle counseling for parents
Receives: Behavioral: Cognitive Behavioural Therapy (CBT); Behavioral: Psycho-Education Program (PEP)
Psycho-Education Program (PEP)ExperimentalGroup-based lifestyle counseling for parents
Receives: Behavioral: Cognitive Behavioural Therapy (CBT); Behavioral: Psycho-Education Program (PEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child BMI Z-score

    Measured: Pre-intervention

  2. Child BMI Z-score

    Measured: post-intervention

  3. Child BMI Z-score

    Measured: 6-months post-intervention

  4. Child BMI Z-score

    Measured: 12-months post-intervention

Secondary outcomes (16)

  1. Lifestyle behaviours

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

    Measured: Pre-intervention

  2. Parental stress

    Parental stress index (PSI)

    Measured: Pre-intervention

  3. Cardiometabolic risk factors

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

    Measured: Pre-intervention

  4. Family functioning

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

    Measured: Pre-intervention

  5. Lifestyle behaviours

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

    Measured: post-intervention

  6. Lifestyle behaviours

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

    Measured: 6-months post-intervention

  7. Lifestyle behaviours

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

    Measured: 12-months post-intervention

  8. Parental stress

    Parental stress index (PSI)

    Measured: post-intervention

  9. Parental stress

    Parental stress index (PSI)

    Measured: 6-months post-intervention

  10. Parental stress

    Parental stress index (PSI)

    Measured: 12-months post-intervention

  11. Cardiometabolic risk factors

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

    Measured: post-intervention

  12. Cardiometabolic risk factors

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

    Measured: 6-months post-intervention

  13. Cardiometabolic risk factors

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

    Measured: 12-months post-intervention

  14. Family functioning

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

    Measured: post-intervention

  15. Family functioning

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

    Measured: 6-months post-intervention

  16. Family functioning

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

    Measured: 12-months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionSep 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01267097
Sponsor's protocol ID
PCWH01-2009
Other IDs
CIHR-MSH83715
Acronym
PAC
Status last verified
Feb 2014
First submitted
16 Dec 2010
Last updated
20 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28086848

  • Ball 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.

    PubMed 22866998

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioural Therapy (CBT) and Psycho-Education Program (PEP) in people with Obesity and Child, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child BMI Z-score (time frame: Pre-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01267097, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.

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