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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
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.
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.
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: At post-treatment 18-month follow-up visit
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).
Time frame: 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
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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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At post-treatment 18-month follow-up visit