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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01789671
Other study ID # SafewayFoundationSaelens-01
Secondary ID
Status Completed
Phase N/A
First received December 12, 2012
Last updated May 19, 2015
Start date September 2012
Est. completion date June 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:

The current study seeks to test the alternative approach of partnering with families, and more specifically parents who have previously received family-based weight control treatment, to serve as peer interventionists to deliver this treatment to other families. Peer-led interventions, common for other health behaviors among adults, has not been previously developed or tested for family-based pediatric weight control intervention. Peer-delivered interventions considerably reduce the high costs of delivering behavioral interventions and could increase the availability of those able to deliver the intervention. In fact, peer interventionists' may be better able to deliver intervention than professionals to families, given these peers have faced similar challenges and barriers to behavior change within their own families. It is also possible that continued engagement in the behavior change process through delivering this intervention to other families could improve peer interventionists' own family's long-term health behaviors and outcomes.

Before utilizing a peer delivery approach more broadly, the novel approach of peer-delivered intervention requires development of training/supervision for peer interventionists and initial evaluation of acceptability/feasibility and efficacy. Therefore, this project has the following aims:

1. To develop procedures for training and supervising of parents to be peer interventionists, based on our prior intervention delivery experience and family advisory board input

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

3. To compare change in weight and health behavior outcomes of overweight/obese children and parents receiving peer- versus professionally-delivered intervention

This study begins to address the high cost and limited availability of the needed, but intense, family-based pediatric weight control intervention required for efficacy. This approach expands the interdisciplinary nature of this work by engaging the resources and assets of previously treated families to contribute to the reduction of the burden of childhood obesity. Led by a project director (Saelens) and intervention coordinator (Scholz) with over 20 years of combined experience in family-based pediatric weight control intervention, this project moves this intervention in a different and important direction.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date June 2014
Est. primary completion date March 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: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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 Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision 20 weeks No
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