NCT01145833

Brief Summary

The purpose of this study is to evaluate whether a home based program can teach parents and moderately overweight kids who are of 8-12 years old with a BMI% between 85-97%, how to manage their child's weight. The study uses manuals and involves a short visit to the clinic every other week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2009

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

Study Start

First participant enrolled

October 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

August 19, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

June 14, 2010

Results QC Date

December 1, 2015

Last Update Submit

August 18, 2020

Conditions

Keywords

obesityguided self help treatmenttreatment methodoverweightoverweight children and parentsfamilies with overweight childefficacybody mass indexweight

Outcome Measures

Primary Outcomes (1)

  • Child BMI

    5 months

Secondary Outcomes (1)

  • Parent BMI

    5 months

Study Arms (2)

Immediate treatment group

ACTIVE COMPARATOR

The immediate treatment group begins the 5-month treatment immediately after baseline assessment.

Other: Immediate Treatment Group

Delayed Treatment Group

OTHER

The delayed treatment group serves as the control group. This group starts treatment 5 months after the baseline assessment. No intervention is involved during this 5-month waiting period. After 5 months, the delayed group is assessed for the second time and then begins the 5-month treatment.

Other: Delayed Treatment Group

Interventions

The immediate treatment group starts the 5-month treatment right after baseline assessment.

Immediate treatment group

The delayed treatment group does not start treatment immediately after the baseline assessment. This group serves as the control group, by not receiving any treatment for 5 months. After the 5 months, the delayed group participants are asked to come in for a second assessment that involves completion of surveys and measurement of height, weight, and physical activity level. After this assessment is completed, the delayed group participants can begin the 5-month treatment.

Also known as: Delayed Treatment Group (Control)
Delayed Treatment Group

Eligibility Criteria

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

You may qualify if:

  • child between the ages of 8 \& 12
  • an moderately overweight child with a BMI% between 85-97%
  • child has a parent willing to participate
  • child has a parent who can read English at a minimum of a 6th grade level
  • family who is willing to commit to treatment attendance and attendance at all assessments.

You may not qualify if:

  • Child psychiatric disorder diagnoses (based on parent report)
  • Child diagnoses of a serious current physical disease (such as diabetes)
  • Child who is taking medications that may impact their weight
  • Child with physical difficulties that limit the ability to exercise
  • Child with an active eating disorder
  • Child and parent will be moving out of the San Diego County before study completion
  • Child and/or parent has a modified diet due to religious or socially conscious reasons (such as Vegan, vegetarian)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Center for Obesity and Health//Pediatrics Department

La Jolla, California, 92037, United States

Location

Related Publications (7)

  • Epstein LH, Wing RR, Koeske R, Andrasik F, Ossip DJ. Child and parent weight loss in family-based behavior modification programs. J Consult Clin Psychol. 1981 Oct;49(5):674-85. doi: 10.1037//0022-006x.49.5.674. No abstract available.

  • Epstein LH, Kilanowski CK, Consalvi AR, Paluch RA. Reinforcing value of physical activity as a determinant of child activity level. Health Psychol. 1999 Nov;18(6):599-603.

  • Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.

  • Peterson CB, Mitchell JE, Engbloom S, Nugent S, Pederson Mussell M, Crow SJ, Thuras P. Self-help versus therapist-led group cognitive-behavioral treatment of binge eating disorder at follow-up. Int J Eat Disord. 2001 Dec;30(4):363-74. doi: 10.1002/eat.1098.

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

  • Accurso EC, Norman GJ, Crow SJ, Rock CL, Boutelle KN. The role of motivation in family-based guided self-help treatment for pediatric obesity. Child Obes. 2014 Oct;10(5):392-9. doi: 10.1089/chi.2014.0023. Epub 2014 Sep 2.

  • Boutelle KN, Norman GJ, Rock CL, Rhee KE, Crow SJ. Guided self-help for the treatment of pediatric obesity. Pediatrics. 2013 May;131(5):e1435-42. doi: 10.1542/peds.2012-2204. Epub 2013 Apr 1.

MeSH Terms

Conditions

ObesityOverweightBody Weight

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Kerri Boutelle, Principal Investigator
Organization
University of CA, San Diego Center for Healthy Eating and Activity Research

Study Officials

  • Kerri Boutelle, PhD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Professor

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 17, 2010

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

September 3, 2020

Results First Posted

August 19, 2020

Record last verified: 2020-08

Locations