- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01789671
Peer Counseling in Family-Based Treatment for Childhood Obesity (EPICH)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98121
- Seattle Children's
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer Interventionist
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.
|
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
|
|
Active Comparator: Professional Interventionist
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.
|
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Child BMI z-score
Time Frame: 20 weeks
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: 20 weeks
|
Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision
|
20 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian E. Saelens, PhD, Seattle Children's
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SafewayFoundationSaelens-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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