Parents as the Agent of Change for Childhood Obesity

NCT ID: NCT01197443

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-07-31

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parent-only Group

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.

Group Type EXPERIMENTAL

Parent-only Group

Intervention Type BEHAVIORAL

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 arm will be administered in two separate groups, one for the parents and one for the child.

Group Type ACTIVE_COMPARATOR

Parent + Child Group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Parents as the Agent of Change for Childhood Obesity (PAAC) Parents as the Agent of Change for Childhood Obesity (PAAC)

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Kerri Boutelle

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kerri Boutelle, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18302765 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8646260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7452420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2232019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11986487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11494642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15601964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17442696 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39009764 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32048808 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30638271 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28558104 (View on PubMed)

Other Identifiers

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071669

Identifier Type: -

Identifier Source: org_study_id