Clinical Trials Logo

Clinical 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). 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01267097
Study type Interventional
Source University of Alberta
Contact
Status Completed
Phase N/A
Start date September 2010
Completion date January 2014

See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2