NCT02580162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

5.1 years

First QC Date

October 14, 2015

Last Update Submit

March 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment

Secondary Outcomes (2)

  • Costs of Peer Versus Professional Treatment

    20 weeks

  • Change in Parent BMI

    Baseline, 20 Weeks (post treatment), 6 and 12 months post treatment

Study Arms (4)

Pro.Treatment, Not a Peer

ACTIVE COMPARATOR

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

Behavioral: FBT for Pediatric Weight Management by Professionals

Pro.Treatment, Peer

EXPERIMENTAL

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

Behavioral: FBT for Pediatric Weight Management by ProfessionalsBehavioral: Peer Interventionists

Peer Treatment, Not a Peer

EXPERIMENTAL

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

Behavioral: FBT for Pediatric Weight Management by Peers

Peer Treatment, Peer

EXPERIMENTAL

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

Behavioral: FBT for Pediatric Weight Management by PeersBehavioral: Peer Interventionists

Interventions

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.

Pro.Treatment, Not a PeerPro.Treatment, Peer

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.

Peer Treatment, Not a PeerPeer Treatment, Peer

Parents who receive FBT complete 6 weeks of training and then serve as peer interventionists to a new group of families.

Peer Treatment, PeerPro.Treatment, Peer

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's

Seattle, Washington, 98121, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian E Saelens, PhD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 20, 2015

Study Start

December 1, 2015

Primary Completion

December 20, 2020

Study Completion

December 20, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations