NCT00359957

Brief Summary

The purpose of this trial is to examine whether adding greater physical activity to standard family-based behavioral pediatric obesity treatment decreases the amount of visceral fat among treated overweight children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Jul 2006

Typical duration for phase_1 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

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

Enrollment Period

1.4 years

First QC Date

August 1, 2006

Last Update Submit

March 1, 2010

Conditions

Obesity

Keywords

Pediatric obesityPhysical activityVisceral fatWeight

Outcome Measures

Primary Outcomes (1)

  • Visceral adiposity

    Change over 3-4 month period

Secondary Outcomes (4)

  • Subcutaneous abdominal adiposity

    Change over 3-4 month period

  • Total body fat

    Change over 3-4 month period

  • Body mass index

    Change over 3-4 month period

  • Physical activity

    Change over 3-4 month period

Study Arms (2)

1

EXPERIMENTAL

ADDED condition - behavioral intervention for modifying diet and physical activity, with greater emphasis on physical activity than the STANDARD condition

Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)

2

ACTIVE COMPARATOR

STANDARD condition - behavioral intervention for modifying diet, with little emphasis on physical activity

Behavioral: Pediatric Obesity Intervention (STANDARD)

Interventions

Pediatric Obesity Intervention (STANDARD)BEHAVIORAL

14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)

2
Pediatric Obesity Intervention + High Activity (ADDED)BEHAVIORAL

14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)

1

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • \>85th percentile BMI
  • have at least one parent with a BMI\>25
  • able to engage in at least moderate intensity physical activity
  • child and parent willing and able to participate in behavioral treatment
  • English-speaking

You may not qualify if:

  • child or parent already enrolled in another weight control program
  • child or parent with a medical condition known to affect weight or growth
  • child or parent with significant mental illness that would interfere with engaging in treatment
  • child or parent with a current or past diagnosed eating disorder
  • child or parent currently taking any medication that affects weight or growth
  • child who is more than 120% above their median BMI for age and gender

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital and Regional Medical Center

Seattle, Washington, 98115, United States

Location

Related Publications (1)

  • Saelens BE, Grow HM, Stark LJ, Seeley RJ, Roehrig H. Efficacy of increasing physical activity to reduce children's visceral fat: a pilot randomized controlled trial. Int J Pediatr Obes. 2011 Apr;6(2):102-12. doi: 10.3109/17477166.2010.482157. Epub 2010 Jun 7.

    PMID: 20528109DERIVED

MeSH Terms

Conditions

ObesityPediatric ObesityMotor ActivityBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Brian E Saelens, Ph.D.

    Children's Hospital and Regiona Medical Center, Seattle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 1, 2006

First Posted

August 3, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(1)