NCT04364282

Brief Summary

Attrition from pediatric weight management programs is unacceptably high, with dropout ranging from 27-73%. This project will utilize a model that predicts dropout from treatment, increasing its power and accuracy through a multi-site observational study. This will result in a powerful tool that will be used to decrease attrition from pediatric weight management, with the potential for widespread dissemination to improve treatment outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 6, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

April 21, 2020

Last Update Submit

March 25, 2026

Conditions

Pediatric ObesityAttritionFamily ResearchWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Attrition from weight management

    Completion of treatment is defined as completing 6 months of participation in weight-management program (attending the recommended number of visits, and still considered active after 6 months)

    6 months

Secondary Outcomes (14)

  • Body mass index (BMI) z score

    6 months

  • Percent of the 95th percentile BMI

    6 months

  • Body weight

    6 months

  • Family Health Habits

    6 months

  • General and psychosocial health (Parent)

    6 months

  • +9 more secondary outcomes

Study Arms (2)

Care team informed

ACTIVE COMPARATOR

Participants in this study will be children and their parents taking part in existing pediatric weight-management programs at participating sites. In this group, members of the weight-management care team will be informed of the family's risk profile for attrition.

Other: Care team informed

Control

PLACEBO COMPARATOR

Participants in this study will be children and their parents taking part in existing pediatric weight-management programs at participating sites. In this group, members of the weight-management care team will not be informed of the family's risk profile for attrition.

Other: Control

Interventions

Care team informedOTHER

Members of the weight-management care team will be informed of the family's risk profile for attrition and may employ additional contacts to enhance chances of retention.

Care team informed
ControlOTHER

Members of the weight-management care team will not be aware of the family's risk profile for attrition.

Control

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Child is 7-18 years of age
  • Participating child has been referred to one of the participating weight management programs, and the family (child-parent dyad) has chosen to participate in said program.
  • Participating child is obese (BMI ≥95th percentile for age and sex).
  • Participating child provides assent to participation in the research study.
  • At least one parent/guardian consents to participate (and consent to child participation).
  • The parent should be the primary parent accompanying the child to treatment, and the child's primary residence must be with that parent.
  • \- Both members of the parent-child dyad must speak either English or Spanish.

You may not qualify if:

  • Participating child cannot complete measures and study activities (non-verbal, significant developmental and behavioral challenges).
  • Participating child has a chronic illness that impacts weight (i.e. cancer).
  • Participating child with a genetic condition (i.e. Prader-Willi) that is associated with excessive weight.
  • One member of the parent-child dyad refuses to participate in the study or does not wish to complete 6 months of treatment.
  • One member of the parent-child dyad is unable to participate in 6 month follow-up data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Brenner Children's Hospital

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (3)

  • Skelton JA, Rhodes ET, Hampl SE, Eneli I, Ip EH; SIT Study Research Group. Proximal and Distal Factors Associated With Obesity in Childhood: An Exploratory Structural Equation Model. Obes Sci Pract. 2026 Feb 27;12(2):e70124. doi: 10.1002/osp4.70124. eCollection 2026 Apr.

    PMID: 41767161BACKGROUND

  • Fleischman A, Hampl S, Rhodes ET, Sweeney B, Eneli I, Skelton JA. Implementation of recommended treatment for children in weight management programs: Lessons from the stay in treatment study sites. Prev Med. 2024 May;182:107949. doi: 10.1016/j.ypmed.2024.107949. Epub 2024 Apr 5.

    PMID: 38583602BACKGROUND

  • Berry DC, Rhodes ET, Hampl S, Young CB, Cohen G, Eneli I, Fleischman A, Ip E, Sweeney B, Houle TT, Skelton J. Stay in treatment: Predicting dropout from pediatric weight management study protocol. Contemp Clin Trials Commun. 2021 Jun 9;22:100799. doi: 10.1016/j.conctc.2021.100799. eCollection 2021 Jun.

    PMID: 34169176BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityTooth WearWeight Loss

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic DiseasesBody Weight Changes

Study Officials

  • Joseph A Skelton, MD, MS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 28, 2020

Study Start

July 6, 2020

Primary Completion

March 26, 2025

Study Completion

March 26, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)