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Peer Counseling in Family-Based Treatment for Childhood Obesity (EPICH)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based behavioral intervention
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood Obesity

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seattle Children's

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peer Interventionist

Professional Interventionist

Arm Description

Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by parents who previously received this treatment (PEER). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.

Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by behavioral specialists(PROFESSIONAL). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.

Outcomes

Primary Outcome Measures

Child BMI z-score

Secondary Outcome Measures

Acceptability
Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision

Full Information

First Posted
December 12, 2012
Last Updated
May 19, 2015
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01789671
Brief Title
Peer Counseling in Family-Based Treatment for Childhood Obesity
Acronym
EPICH
Official Title
Peer Counseling in Family-Based Treatment for Childhood Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Interventionist
Arm Type
Experimental
Arm Description
Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by parents who previously received this treatment (PEER). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
Arm Title
Professional Interventionist
Arm Type
Active Comparator
Arm Description
Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by behavioral specialists(PROFESSIONAL). This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
Intervention Type
Behavioral
Intervention Name(s)
Family-based behavioral intervention
Intervention Description
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
Primary Outcome Measure Information:
Title
Child BMI z-score
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Acceptability
Description
Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian E. Saelens, PhD
Organizational Affiliation
Seattle Children's
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's
City
Seattle
State/Province
Washington
ZIP/Postal Code
98121
Country
United States

12. IPD Sharing Statement

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Peer Counseling in Family-Based Treatment for Childhood Obesity

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