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Success in Health: Impacting Families Together (SHIFT)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FBT for Pediatric Weight Management by Professionals
FBT for Pediatric Weight Management by Peers
Peer Interventionists
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

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 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Pro.Treatment, Not a Peer

Pro.Treatment, Peer

Peer Treatment, Not a Peer

Peer Treatment, Peer

Arm Description

Families receive FBT for Pediatric Weight Management by Professionals interventionists and parents are NOT Peer Interventionists

Families receive FBT for Pediatric Weight Management by Professionals and parents ARE Peer Interventionists

Families receive FBT for Pediatric Weight Management by Peers and parents are NOT Peer Interventionists

Families receive FBT for Pediatric Weight Management by Peers and parents ARE Peer Interventionists

Outcomes

Primary Outcome Measures

Change in Child BMI z-score
BMI will be calculated as kg/m2 and children's BMI z-scores will be calculated using CDC growth charts.

Secondary Outcome Measures

Costs of Peer Versus Professional Treatment
Direct and indirect costs of associated with intervention using peer or professional interventionists. Direct costs will be estimated using hours spent providing treatment of both peers and professionals who will track their time using an online application. Costs associated with hours spent will be based on professional salaries or stipends provided to peer interventionists.
Change in Parent BMI
BMI of parent will be calculated as kg/m2.

Full Information

First Posted
October 14, 2015
Last Updated
March 30, 2021
Sponsor
Seattle Children's Hospital
Collaborators
University of Washington, San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT02580162
Brief Title
Success in Health: Impacting Families Together
Acronym
SHIFT
Official Title
Parents as Peer Interventionists in Treatment for Pediatric Weight Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
University of Washington, San Diego State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates and compares the efficacy of professional versus peer-based delivery of family-based treatment for childhood overweight and obesity in elementary school aged children. Families will be randomized to receive treatment from professionals or to receive treatment from professionally-trained peer interventionists. Some parents will then be invited to serve as peer interventionists for the next group of families.
Detailed Description
The high prevalence of pediatric overweight and obesity in the U.S. necessitates the development of efficacious, but cost-effective and easily disseminable interventions that improve and sustain better pediatric weight outcomes. Accumulated evidence finds initial and long-term efficacy of moderate-to-high intensity (>25 contact hours) family-based treatment (FBT) for elementary school-aged children, but such treatment is prohibitively expensive because of high personnel costs (delivery by behavioral health professionals) and therefore limited in availability, reach, and impact. Very few overweight/obese children receive evidence-based treatment to improve their weight status or health. The pilot data suggest a new model, peer-based delivery FBT with FBT-treated parents trained and subsequently delivering FBT to other families, is feasible and demonstrates initial efficacy. This delivery model could dramatically reduce FBT costs and increase FBT availability. Preliminary data also suggest that serving as a peer interventionist may also benefit the peers themselves and their children in better sustaining their own weight outcomes. The present study aims to provide a more definitive test of the short- and long-term efficacy of peer- versus professionally-delivered FBT on child weight outcomes. Embedded in this comparison is an examination of the feasibility of peer-based FBT delivery, investigating the impact of serving as a peer interventionist on the peers' own and their child's long- term weight status, and a more comprehensive examination of differential costs of professional- versus peer- based FBT delivery. The present study will also test potential dissemination and sustainability by examining the efficacy of peer-delivered FBT among peer interventionists who themselves received FBT from other peers and not from professional interventionists. Moderation of treatment outcome is also examined, focusing on peer interventionist and child characteristics. This multi-phase trial will enroll 304 families with 7-11 year old overweight/obese children in multiple sites throughout the region, and include short-term (post-treatment) and long-term (up through 1 year after treatment cessation) assessments. This investigation of an innovative approach that could significantly reduce FBT delivery costs, while also improving the maintenance of treatment effects, is critical to improving the health of the many already overweight children at risk for chronic disease.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pro.Treatment, Not a Peer
Arm Type
Active Comparator
Arm Description
Families receive FBT for Pediatric Weight Management by Professionals interventionists and parents are NOT Peer Interventionists
Arm Title
Pro.Treatment, Peer
Arm Type
Experimental
Arm Description
Families receive FBT for Pediatric Weight Management by Professionals and parents ARE Peer Interventionists
Arm Title
Peer Treatment, Not a Peer
Arm Type
Experimental
Arm Description
Families receive FBT for Pediatric Weight Management by Peers and parents are NOT Peer Interventionists
Arm Title
Peer Treatment, Peer
Arm Type
Experimental
Arm Description
Families receive FBT for Pediatric Weight Management by Peers and parents ARE Peer Interventionists
Intervention Type
Behavioral
Intervention Name(s)
FBT for Pediatric Weight Management by Professionals
Intervention Description
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is delivered by PROFESSIONAL interventionists.
Intervention Type
Behavioral
Intervention Name(s)
FBT for Pediatric Weight Management by Peers
Intervention Description
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is provided by PEER interventionists.
Intervention Type
Behavioral
Intervention Name(s)
Peer Interventionists
Intervention Description
Parents who receive FBT complete 6 weeks of training and then serve as peer interventionists to a new group of families.
Primary Outcome Measure Information:
Title
Change in Child BMI z-score
Description
BMI will be calculated as kg/m2 and children's BMI z-scores will be calculated using CDC growth charts.
Time Frame
Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment
Secondary Outcome Measure Information:
Title
Costs of Peer Versus Professional Treatment
Description
Direct and indirect costs of associated with intervention using peer or professional interventionists. Direct costs will be estimated using hours spent providing treatment of both peers and professionals who will track their time using an online application. Costs associated with hours spent will be based on professional salaries or stipends provided to peer interventionists.
Time Frame
20 weeks
Title
Change in Parent BMI
Description
BMI of parent will be calculated as kg/m2.
Time Frame
Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment

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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Success in Health: Impacting Families Together

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