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

November 30, 2015 updated by: Kerri Boutelle, University of California, San Diego
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD Center for Healthy Eating and Activity Research (CHEAR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Parents as the Agent of Change for Childhood Obesity (PAAC)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
At post-treatment visit (after 6-month 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
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.
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
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.
At post-treatment 18-month follow-up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
Time Frame: At post-treatment visit (after 6-month treatment)
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).
At post-treatment visit (after 6-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)
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.
At post-treatment (after 6-month treatment)
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)
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.
At post-treatment visit (after 6-month treatment)
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)
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.
At post-treatment visit (after 6-month treatment)
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)
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.
At post-treatment visit (after 6-month treatment)
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)
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.
At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Time Frame: At post-treatment visit (after 6-month treatment)
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.
At post-treatment visit (after 6-month treatment)
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)
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.
At post-treatment visit (after 6-month 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)
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Time Frame: At post-treatment visit (after 6-month treatment)
Compliance will be measured by group attendance and adherence to behavior recommendations.
At post-treatment visit (after 6-month treatment)
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)
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
At post-treatment visit (after 6-month treatment)
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)
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
At post-treatment visit (after 6-month treatment)
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)
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.
At post-treatment visit (after 6-month treatment)
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
Time Frame: At post-treatment 6-month follow-up visit
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.
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
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.
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 18-month follow-up visit
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.
At post-treatment 18-month follow-up visit
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
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.
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 exercise behavior
Time Frame: At post-treatment 18-month follow-up visit
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.
At post-treatment 18-month follow-up visit
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
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.
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 quality of life
Time Frame: At post-treatment 18-month follow-up visit
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.
At post-treatment 18-month follow-up visit
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
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.
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 psychosocial measures
Time Frame: A post-treatment 18-month follow-up visit
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.
A post-treatment 18-month follow-up visit
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
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.
At post-treatment 6-month follow-up visit
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
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.
At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Time Frame: At post-treatment 6-month follow-up visit
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.
At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Time Frame: At post-treatment 18-month follow-up visit
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.
At post-treatment 18-month follow-up visit
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
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.
At post-treatment 6-month follow-up visit
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
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.
At post-treatment 18-month follow-up visit
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
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
At post-treatment 6-month follow-up visit
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
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Time Frame: At post-treatment 6-month follow-up visit
Compliance will be measured by group attendance and adherence to behavior recommendations.
At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Time Frame: At post-treatment 18-month follow-up visit
Compliance will be measured by group attendance and adherence to behavior recommendations.
At post-treatment 18-month follow-up visit
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
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
At post-treatment 6-month follow-up visit
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
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
At post-treatment 18-month follow-up visit
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
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
At post-treatment 6-month follow-up visit
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
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
At post-treatment 18-month follow-up visit
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
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.
At post-treatment 6-month follow-up visit
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
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.
At post-treatment 18-month follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kerri Boutelle, PhD, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 071669

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