Parents as the Agent of Change for Childhood Obesity (PAAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01197443
First received: August 17, 2010
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity via parent education only, and to evaluate the cost effectiveness compared to the current gold standard treatment of parent-and-child dual education.


Condition Intervention
Obesity
Behavioral: Parent-only Group
Behavioral: Parent + Child Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Parents as the Agent of Change for Childhood Obesity

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment immediately following treatment.

  • To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 6-month follow-up visit.

  • To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 18-month follow-up visit.


Secondary Outcome Measures:
  • To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    We predict that the parent-only treatment will be more cost-effective than the parent + child group, as measured by calculating cost effectiveness ratios from both third party payer and limited societal perspectives at post-treatment visit (after 5-month treatment).

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality [ Time Frame: At post-treatment (after 6-month treatment) ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaire measures specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on parent's adherence [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by group attendance and adherence to behavior recommendations.

  • To compare effect of parent-only treatment versus parent + child treatment on parenting style [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.

  • To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.

  • To evaluate the predictors of success in childhood obesity treatments by evaluating compliance [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    Compliance will be measured by group attendance and adherence to behavior recommendations.

  • To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).

  • To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.

  • To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning [ Time Frame: At post-treatment visit (after 6-month treatment) ] [ Designated as safety issue: No ]
    Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.

  • To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    We predict that the parent-only treatment will be more cost-effective than the parent + child group, as measured by calculating cost effectiveness ratios from both third party payer and limited societal perspectives at post-treatment 6-month follow-up visit.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaire measures specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaire measures specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures [ Time Frame: A post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on parent's adherence [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by group attendance and adherence to behavior recommendations.

  • To compare effect of parent-only treatment versus parent + child treatment on parent's adherence [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by group attendance and adherence to behavior recommendations.

  • To compare effect of parent-only treatment versus parent + child treatment on parenting style [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on parenting style [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.

  • To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.

  • To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.

  • To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.

  • To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.

  • To evaluate the predictors of success in childhood obesity treatments by evaluating compliance [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    Compliance will be measured by group attendance and adherence to behavior recommendations.

  • To evaluate the predictors of success in childhood obesity treatments by evaluating compliance [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    Compliance will be measured by group attendance and adherence to behavior recommendations.

  • To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).

  • To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).

  • To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.

  • To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.

  • To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning [ Time Frame: At post-treatment 6-month follow-up visit ] [ Designated as safety issue: No ]
    Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.

  • To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning [ Time Frame: At post-treatment 18-month follow-up visit ] [ Designated as safety issue: No ]
    Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.


Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parent-only Group
Treatment will be administered to parents of the overweight child. Parent-only group treatment will include all of the same skills and techniques to promote weight loss, but the information will be delivered only to the parent. Participation of the children assigned to the parent-only treatment arm will be limited to the baseline and follow-up assessments.
Behavioral: Parent-only Group
Parent-only group will include the same skills and techniques to promote weight loss as given to the parent + child group, but the information will be delivered only to the parent. Parent group will be compared to the parent group of the parent + child treatment arm. The focus will be on implementing skills learned to assist the child in weight management. The treatment length is set for 12 weekly meetings and bi-monthly meetings during months 4 and 5. Each group session will be 60-min including weigh-ins. Group meetings focus on behavior change, weight loss, healthy eating and activity for the overweight child and parent.
Other Name: Parents as the Agent of Change for Childhood Obesity (PAAC)
Active Comparator: Parent + child Group
The treatment for participants in the parent + child arm will be administered in two separate groups, one for the parents and one for the child.
Behavioral: Parent + Child Group
The treatment for participants in the parent + child group will be administered in two separate groups, one for the parents and one for the child. Treatment will include the same skills and techniques to promote weight loss as given to the parent-only group, but the information will be delivered to both the parent and child. The treatment length, session schedule, treatment content and follow-up assessments are same as the parent-only group.
Other Name: Parents as the Agent of Change for Childhood Obesity (PAAC)

Detailed Description:

This study is a randomized clinical trial in which 150 overweight 8-12 year old children and their parent will be randomly assigned by the gender of the child to one of two conditions; a parent-only intervention or a parent + child intervention. Both treatment arms will provide behavioral treatment for childhood obesity for 5 months, and participants will be followed for 18-months post-treatment. Assessments will occur at baseline, immediately post-treatment, 6-12- and 18-months post-treatment. The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity (parent-only), and to evaluate the cost effectiveness compared to the current gold standard treatment of parent + child. Results of these studies will be utilized as evidence to recommend changes in the standard treatment for childhood obesity. This program of research is critical for exploring and developing interventions that mobilize parents to intervene with their overweight and obese children. The timing of this research is optimal given the increase in childhood obesity in the United States, and the need for disseminative intervention and prevention programs.

  Eligibility

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

Inclusion Criteria:

  • Overweight child 8-12 years of age and above the 95th% for age and gender
  • An overweight (BMI > 25) parent willing to participate and attend all treatment meetings
  • Eligible parent who can read at a minimum of an 8th grade level
  • Family willing to commit to 5 months of treatment attendance, and follow-up for 18 months post-treatment.

Exclusion Criteria:

  • Major child psychiatric disorder diagnoses
  • Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed (self-report)
  • Family with restrictions on types of food, such as food allergies, religious, or ethnic practices that limit the foods available in the home
  • Child with physical difficulties that limit the ability to exercise
  • Child with an active eating disorder (based on EDE interview)
  • Families where children or parents are involved in swimming or weight training more than 5 hours per week
  • Major parent psychiatric disorder
  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: NCT01197443

Contacts
Contact: Martina Cotton, BA 858-822-2158 mcotton@ucsd.edu
Contact: Kerri Boutelle, PhD kboutelle@ucsd.edu

Locations
United States, California
UCSD Center for Healthy Eating and Activity Research (CHEAR) Recruiting
La Jolla, California, United States, 92093
Contact: Kerri Boutelle, PhD       kboutelle@ucsd.edu   
Contact: Martina Cotton, BA    858-534-8088    mcotton@ucsd.edu   
Principal Investigator: Kerri Boutelle, PhD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Kerri Boutelle, PhD UCSD
  More Information

Publications:

Responsible Party: Kerri Boutelle, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01197443     History of Changes
Other Study ID Numbers: 071669
Study First Received: August 17, 2010
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
obesity
childhood obesity
overweight
overweight children
overweight parents
families with overweight child
body mass index
BMI
weight
diet
treatment
parent modeling
traffic light diet
stop light diet

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

ClinicalTrials.gov processed this record on September 18, 2014