MedDataX Logo

Examination of a Treatment Program for Overweight Children, Adolescents, and Their Families

NCT ID: NCT00365807

Last Updated: 2012-11-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of the present investigation was to determine the effectiveness of an empirically supported intervention for pediatric overweight in two outpatient clinical settings. A number of previous randomized clinical trials have demonstrated the efficacy of behaviorally-based group interventions for overweight children and their families. As called for by Kazdin and Weisz (1998) and Chambless and Hollon (1998) the proposed investigation was designed to demonstrate the effectiveness of such a treatment in a clinical setting, and to examine the effects of the intervention on children's quality of life (QOL). Because the clinical impact of empirically supported interventions is mitigated by economic and consumer variables, a secondary aim of the proposed investigation was to examine (1) the cost-effectiveness of an outpatient group intervention for pediatric obesity, and (2) the consumer satisfaction with the proposed intervention. Finally, an additional exploratory aim was to examine predictors of adherence to treatment for the intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Obesity Overweight Behavioral treatment Family involvement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brief Family Intervention (Primarily education)

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

Group Type ACTIVE_COMPARATOR

Brief Family Intervention (Primarily education)

Intervention Type OTHER

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

Positively Fit

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.

Group Type EXPERIMENTAL

Positively Fit

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Positively Fit

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

Intervention Type BEHAVIORAL

Brief Family Intervention (Primarily education)

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Kansas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ric G Steele, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Ann M. Davis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Kansas

Lawrence, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 21852343 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R40MC06631-01-00

Identifier Type: -

Identifier Source: org_study_id