Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The PAC Study: Parents as Agents of Change in Pediatric Weight Management
Brief 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.


Options:
A: Intervention Type: BEHAVIORAL; Name: Targeted parental instruction for positive lifestyle change with follow-up calls.; Assigned to Arm(s): N/A
B: Arm Label: Cognitive Behavioural Therapy (CBT); Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioural Therapy (CBT), Behavioral: Psycho-Education Program (PEP) | Arm Label: Psycho-Education Program (PEP); Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioural Therapy (CBT), Behavioral: Psycho-Education Program (PEP) | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioural Therapy (CBT); Assigned to Arm(s): Cognitive Behavioural Therapy (CBT), Psycho-Education Program (PEP) | Intervention Type: BEHAVIORAL; Name: Psycho-Education Program (PEP); Assigned to Arm(s): Cognitive Behavioural Therapy (CBT), Psycho-Education Program (PEP)
C: Arm Label: Standard Care with Education Materials; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Care | Arm Label: Moderate Dose Motivational Interviewing; Type: EXPERIMENTAL; Interventions: Behavioral: Moderate Dose Motivational Interviewing | Arm Label: Higher Dose Motivational Interviewing; Type: EXPERIMENTAL; Interventions: Behavioral: Higher Dose Motivational Interviewing | Intervention Type: BEHAVIORAL; Name: Standard Care; Assigned to Arm(s): Standard Care with Education Materials | Intervention Type: BEHAVIORAL; Name: Moderate Dose Motivational Interviewing; Assigned to Arm(s): Moderate Dose Motivational Interviewing | Intervention Type: BEHAVIORAL; Name: Higher Dose Motivational Interviewing; Assigned to Arm(s): Higher Dose Motivational Interviewing
D: Arm Label: A: experimental; Type: EXPERIMENTAL; Interventions: Behavioral: Obesity-Children | Arm Label: (B): experimental; Type: EXPERIMENTAL; Interventions: Behavioral: Obesity-Children | Arm Label: (c): experimental; Type: EXPERIMENTAL; Interventions: Behavioral: Obesity-Children | Arm Label: (D): control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Obesity-Children | Intervention Type: BEHAVIORAL; Name: Obesity-Children; Assigned to Arm(s): (B): experimental, (D): control group, (c): experimental, A: experimental

Answer: B