Clinical trial NCT01197443: Parents as the Agent of Change for Childhood Obesity
Official title: Parents as the Agent of Change for Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 152
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
timeFrame: At post-treatment 6-month follow-up visit
measure: To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
timeFrame: At post-treatment 18-month follow-up visit
Secondary outcomes:
measure: To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
timeFrame: At post-treatment (after 6-month treatment)
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To compare effect of parent-only treatment versus parent + child treatment on parenting style
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
timeFrame: At post-treatment visit (after 6-month treatment)
measure: To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
timeFrame: At post-treatment 6-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
timeFrame: At post-treatment 6-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
timeFrame: At post-treatment 18-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
timeFrame: At post-treatment 6-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
timeFrame: At post-treatment 18-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
timeFrame: At post-treatment 6-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
timeFrame: At post-treatment 18-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
timeFrame: At post-treatment 6-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
timeFrame: A post-treatment 18-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
timeFrame: At post-treatment 6-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
timeFrame: At post-treatment 18-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on parenting style
timeFrame: At post-treatment 6-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on parenting style
timeFrame: At post-treatment 18-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
timeFrame: At post-treatment 6-month follow-up visit
measure: To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
timeFrame: At post-treatment 18-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
timeFrame: At post-treatment 6-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
timeFrame: At post-treatment 18-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
timeFrame: At post-treatment 6-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
timeFrame: At post-treatment 18-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
timeFrame: At post-treatment 6-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
timeFrame: At post-treatment 18-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
timeFrame: At post-treatment 6-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
timeFrame: At post-treatment 18-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
timeFrame: At post-treatment 6-month follow-up visit
measure: To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
timeFrame: At post-treatment 18-month follow-up visit
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Healthy Eating and Activity Research (CHEAR)
state: California
Study officials:
affiliation: UCSD
name: Kerri Boutelle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
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. doi: 10.1093/jpepsy/5.1.25. No abstract available.
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.
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. doi: 10.1542/peds.109.5.e81.
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. doi: 10.1016/s0031-3955(05)70347-3.
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. doi: 10.1038/oby.2004.212.
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. doi: 10.1093/pubmed/fdm012. Epub 2007 Apr 18.
citation: Kang Sim DE, Strong DR, Manzano MA, Rhee KE, Boutelle KN. Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. Pediatr Obes. 2020 Jun;15(6):e12622. doi: 10.1111/ijpo.12622. Epub 2020 Feb 12.
citation: Eichen DM, Strong DR, Rhee KE, Rock CL, Crow SJ, Epstein LH, Wilfley DE, Boutelle KN. Change in eating disorder symptoms following pediatric obesity treatment. Int J Eat Disord. 2019 Mar;52(3):299-303. doi: 10.1002/eat.23015. Epub 2019 Jan 14.
citation: Boutelle KN, Rhee KE, Liang J, Braden A, Douglas J, Strong D, Rock CL, Wilfley DE, Epstein LH, Crow SJ. Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jul 1;171(7):622-628. doi: 10.1001/jamapediatrics.2017.0651.