NCT01197443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

4.7 years

First QC Date

August 17, 2010

Last Update Submit

November 30, 2015

Conditions

Keywords

obesityoverweightoverweight childrenoverweight parentsfamilies with overweight childbody mass indexBMIweightchildhood obesitydiettreatmentparent modelingtraffic light dietstop light diet

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (38)

  • To evaluate the cost-effectiveness of parent-only treatment versus parent + child 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

    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

    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

    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

    At post-treatment visit (after 6-month treatment)

  • +33 more secondary outcomes

Study Arms (2)

Parent-only Group

EXPERIMENTAL

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

Parent + child Group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Parents as the Agent of Change for Childhood Obesity (PAAC)
Parent-only 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.

Also known as: Parents as the Agent of Change for Childhood Obesity (PAAC)
Parent + child Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

Location

Related Publications (12)

  • 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.

    PMID: 18302765BACKGROUND
  • Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.

    PMID: 8646260BACKGROUND
  • 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.

    PMID: 7452420BACKGROUND
  • 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.

    PMID: 2232019BACKGROUND
  • 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.

    PMID: 11986487BACKGROUND
  • 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.

    PMID: 11494642BACKGROUND
  • 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.

    PMID: 15601964BACKGROUND
  • 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.

    PMID: 17442696BACKGROUND
  • Boutelle KN, Kang Sim DE, Eichen DM, Manzano MA, Rhee KE, Strong DR. Predictors of parent self-monitoring patterns in a family-based behavioral weight loss treatment program. Int J Obes (Lond). 2024 Oct;48(10):1457-1464. doi: 10.1038/s41366-024-01574-8. Epub 2024 Jul 15.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityOverweightBody WeightPediatric Obesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kerri Boutelle, PhD

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 17, 2010

First Posted

September 9, 2010

Study Start

November 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations