NCT00365807

Brief Summary

The current study examined the effectiveness of a behaviorally-based group intervention for overweight children and their families. The target intervention was compared to an enhanced standard of care treatment. The impact of both treatment programs on numerous outcomes was explored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

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
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

November 5, 2012

Status Verified

November 1, 2012

Enrollment Period

3.4 years

First QC Date

August 17, 2006

Last Update Submit

November 2, 2012

Conditions

Obesity

Keywords

ObesityOverweightBehavioral treatmentFamily involvement

Outcome Measures

Primary Outcomes (1)

  • BMI Percentile Change

    Treatment completion, 1 year follow up

Secondary Outcomes (4)

  • Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001)

    treatment completion, one year follow up

  • Child Psychosocial Adjustment -- the Behavioral Assessment System for Children- Parent report form (BASC-PRF) and the BASC-Child Self Report (BASC-CSR; Reynolds & Kamphaus, 2002)

    Treatment completion, one year follow up

  • Cost-effectiveness

    Treatment completion, one year follow up

  • Consumer Satisfaction

    Treatment completion

Study Arms (2)

Brief Family Intervention (Primarily education)

ACTIVE COMPARATOR

Behaviorally based family group intervention using standard education and nutrition counseling. Three hours of client contact

Other: Brief Family Intervention (Primarily education)

Positively Fit

EXPERIMENTAL

12 week (90 minute per session) behavioral group intervention for children and their parents. Children and parent attend parallel group with identical (but developmentally appropriate) information presented.

Behavioral: Positively Fit

Interventions

Positively FitBEHAVIORAL

12-week group intervention for children with obesity and their parents/caregivers

Positively Fit
Brief Family Intervention (Primarily education)OTHER

3 hours of contact with registered dietician for education and nutritional counseling.

Brief Family Intervention (Primarily education)

Eligibility Criteria

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

You may qualify if:

  • Child between ages 7 and 17 (inclusive)
  • Child BMI at or above the 85th percentile based on norms provided for age and gender
  • Child's parent/guardian provides informed consent for treatment of the child as well as consent for study participation
  • Child's parent/caregiver is willing to participate with the child in the program

You may not qualify if:

  • Presence of serious mental illnesses or significant developmental delay that would reasonably predict altered ability to adhere to the treatment protocol
  • Current physical illness or hospitalization of the child that would interfere with group attendance or protocol adherence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (1)

  • Steele RG, Aylward BS, Jensen CD, Cushing CC, Davis AM, Bovaird JA. Comparison of a family-based group intervention for youths with obesity to a brief individual family intervention: a practical clinical trial of positively fit. J Pediatr Psychol. 2012 Jan-Feb;37(1):53-63. doi: 10.1093/jpepsy/jsr057. Epub 2011 Aug 18.

    PMID: 21852343RESULT

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ric G Steele, Ph.D.

    University of Kansas

    PRINCIPAL INVESTIGATOR

  • Ann M. Davis, Ph.D.

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 18, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

November 5, 2012

Record last verified: 2012-11

Locations

US(2)