Parents as the Agent of Change for Childhood Obesity

Obesity Clinical Trial

— PAAC  

Official title:

Parents as the Agent of Change for Childhood Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197443
• Other study ID #: 071669
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: November 30, 2015
• Start date: November 2010
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCSD Center for Healthy Eating and Activity Research (CHEAR)	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bauer KW, Nelson MC, Boutelle KN, Neumark-Sztainer D. Parental influences on adolescents' physical activity and sedentary behavior: longitudinal findings from Project EAT-II. Int J Behav Nutr Phys Act. 2008 Feb 26;5:12. doi: 10.1186/1479-5868-5-12. Erratum in: Int J Behav Nutr Phys Act. 2011;8:12. — View Citation

Birch LL, Davison KK. Family environmental factors influencing the developing behavioral controls of food intake and childhood overweight. Pediatr Clin North Am. 2001 Aug;48(4):893-907. Review. — View Citation

Clark HR, Goyder E, Bissell P, Blank L, Peters J. How do parents' child-feeding behaviours influence child weight? Implications for childhood obesity policy. J Public Health (Oxf). 2007 Jun;29(2):132-41. Epub 2007 Apr 18. Review. — View Citation

Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year follow-up of behavioral, family-based treatment for obese children. JAMA. 1990 Nov 21;264(19):2519-23. — View Citation

Epstein LH, Wing RR, Steranchak L, Dickson B, Michelson J. Comparison of family-based behavior modification and nutrition education for childhood obesity. J Pediatr Psychol. 1980 Mar;5(1):25-36. — View Citation

Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21. — View Citation

Faith MS, Scanlon KS, Birch LL, Francis LA, Sherry B. Parent-child feeding strategies and their relationships to child eating and weight status. Obes Res. 2004 Nov;12(11):1711-22. Review. — View Citation

Wang G, Dietz WH. Economic burden of obesity in youths aged 6 to 17 years: 1979-1999. Pediatrics. 2002 May;109(5):E81-1. Erratum in: Pediatrics 2002 Jun;109(6):1195. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No