Back to resultsParents as the Agent of Change for Childhood Obesity (PAAC)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent-only Group
Parent + Child Group
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, overweight, overweight children, overweight parents, families with overweight child, body mass index, BMI, weight, childhood obesity, diet, treatment, parent modeling, traffic light diet, stop light diet
Eligibility 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
Sites / Locations
- UCSD Center for Healthy Eating and Activity Research (CHEAR)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parent-only Group
Parent + child Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT01197443
First Posted
August 17, 2010
Last Updated
November 30, 2015
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01197443
Brief Title
Parents as the Agent of Change for Childhood Obesity
Acronym
PAAC
Official Title
Parents as the Agent of Change for Childhood Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, overweight, overweight children, overweight parents, families with overweight child, body mass index, BMI, weight, childhood obesity, diet, treatment, parent modeling, traffic light diet, stop light diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent-only Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Parent + child Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent-only Group
Other Intervention Name(s)
Parents as the Agent of Change for Childhood Obesity (PAAC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent + Child Group
Other Intervention Name(s)
Parents as the Agent of Change for Childhood Obesity (PAAC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Description
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.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Description
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.
Time Frame
At post-treatment 18-month follow-up visit
Secondary Outcome Measure Information:
Title
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
Description
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).
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
Description
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.
Time Frame
At post-treatment (after 6-month treatment)
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
Description
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.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
Description
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.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
Description
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.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
Description
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.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Description
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.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
Description
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.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
Description
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Description
Compliance will be measured by group attendance and adherence to behavior recommendations.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Description
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Description
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Description
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.
Time Frame
At post-treatment visit (after 6-month treatment)
Title
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
Description
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.
Time Frame
At post-treatment 18-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
Description
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.
Time Frame
At post-treatment 18-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
Description
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.
Time Frame
At post-treatment 18-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
Description
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.
Time Frame
A post-treatment 18-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
Description
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.
Time Frame
At post-treatment 18-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Description
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.
Time Frame
At post-treatment 18-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
Description
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.
Time Frame
At post-treatment 18-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
Description
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
Time Frame
At post-treatment 6-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
Description
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
Time Frame
At post-treatment 18-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Description
Compliance will be measured by group attendance and adherence to behavior recommendations.
Time Frame
At post-treatment 6-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Description
Compliance will be measured by group attendance and adherence to behavior recommendations.
Time Frame
At post-treatment 18-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Description
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
Time Frame
At post-treatment 6-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Description
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
Time Frame
At post-treatment 18-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Description
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
Time Frame
At post-treatment 6-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Description
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
Time Frame
At post-treatment 18-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Description
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.
Time Frame
At post-treatment 6-month follow-up visit
Title
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Description
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.
Time Frame
At post-treatment 18-month follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Boutelle, PhD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Center for Healthy Eating and Activity Research (CHEAR)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Citations:
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Parents as the Agent of Change for Childhood Obesity
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