Parents as the Agent of Change for Childhood Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parents as the Agent of Change for Childhood Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Parent-only Group
* Behavioral: Parent + Child Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent-only Group<br>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<br>* 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.<br>* Other names: Parents as the Agent of Change for Childhood Obesity (PAAC);|
| Active Comparator: Parent + child Group<br>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<br>* 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.<br>* Other names: Parents as the Agent of Change for Childhood Obesity (PAAC);|

What is the study measuring?
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Primary Outcome Measures

| 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 | 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 | 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 | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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