Parent Partnership Project

Childhood Obesity Clinical Trial

Official title:

Peer Counseling in Family-Based Pediatric Overweight Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789944
• Other study ID #: 1R21DK095676-01
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: May 19, 2015
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention.

Description:

A new model of delivering family-based pediatric overweight treatment that decreases costs but sustains short- and long-term efficacy is needed. One possible opportunity for this is a peer intervention model in which families receiving professionally-led intervention then subsequently providing intervention to other families. In addition, peer interventionists' continued engagement in the behavior change process through providing intervention to others could improve their own long-term efficacy. The project begins with the standard approach of having professional interventionists provide family-based behavioral pediatric overweight treatment to overweight children and their parent (1st generation families; n=30). Subsequently, half of 1st generation families will be randomly assigned to serve as peer interventionists to other overweight parents and children (2nd generation families; n=30). The remaining 1st generation families will neither receive nor provide any additional treatment. This project aims to develop the peer intervention training and delivery and then to examine the feasibility and acceptability of the peer intervention. This project also aims to derive an estimate of the efficacy of peer intervention (receiving and providing) both at the end of receiving treatment and 6 months later, as well as the impact of providing intervention on peer interventionists' weight outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• Child age: 7-11 years at time of enrollment

• Overweight child: at or above 85th percentile for age- and gender-specific BMI.

• At least one overweight parent (BMI= 25.0).

• Parent is willing and able to actively participate in treatment including willingness to serve as a peer interventionist following treatment.

• Must live within 50 miles of the treatment center.

Exclusion Criteria:

• Current enrollment in another weight control program for the participating child or parent.

• The participating parent is pregnant.

• Thought disorder, suicidality, or substance abuse disorder in either the participating parent or the participating child.

• Inability of the child to comprehend English at a 1st-grade level or participating parent to comprehend English at an 8th-grade level.

• Physical disability or illness in either the participating parent or the child that precludes moderate intensity physical activity.

• Medication regimen for the child that affects his or her weight.

• Conditions known to promote obesity in the participating child (e.g. Prader-Willi).

• Diagnosed eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) in either parent (participating and nonparticipating) and/or the participating child.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Behavioral: Family-based behavioral intervention
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change

Locations

Country	Name	City	State
United States	Seattle Children's	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child BMI z-score		20 Weeks	No
Secondary	Acceptability & Feasibility	Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision	11 months	No

External Links

•   Related Info