NCT04362280

Brief Summary

This study will evaluate the preliminary efficacy of a school-based weight management program for underserved adolescents. The program was designed with a phased treatment structure to provide more intensive treatment to participants who do not respond to treatment initially. Specifically, this study aims to examine differences in zBMI over time between students who do not respond to the first semester and receive more intensive treatment in the second semester, responders to first semester who receive more intensive treatment in the second semester, non-responders to the first semester who receive usual treatment in the second semester, and responders who receive usual treatment in the second semester at the end of the second semester, 1 year follow-up, and 2 year follow-up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
392

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 20, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

April 22, 2020

Last Update Submit

April 23, 2020

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

  • Standardized BMI

    Examine zBMI over the course of the intervention between study arms

    up to 2 years

Secondary Outcomes (1)

  • Social Network

    up to 6 months

Other Outcomes (1)

  • Carotenoid levels

    up to two years

Study Arms (2)

ReCHARGE

EXPERIMENTAL

intervention intensity is increased through: the creation of family groups, greater involvement of school staff, separate lessons for females, health screeners will be home and families are invited to a nutrition counseling session with a registered dietitian.

Behavioral: ReCHARGE

Treatment as Usual (TAU)

ACTIVE COMPARATOR

PE class as usual which consisted of choice time.

Behavioral: TAU

Interventions

ReCHARGEBEHAVIORAL

During their PE class, all participants (both arms) participate in an intensive lifestyle intervention with established efficacy among this population for the academic fall semester. The following semester, participants are randomized to different treatment arms. ReCHARGE increases the intensity of treatment provided in the first semester by increasing social support and addressing common barriers youth have to adhering to intervention.

ReCHARGE
TAUBEHAVIORAL

PE class as usual led by PE teacher.

Treatment as Usual (TAU)

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 10-17 years old
  • Student enrolled in a Physical Education (PE) class at the YES Prep Brays Oak Campus during either the 2018-2019 or 2019-2020 school year
  • provides written parental consent and student assent

You may not qualify if:

  • Is pregnant or becomes pregnant during the study.
  • Is unable to participate in PE class for more than 5 consecutive school days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

YES Prep Brays Oaks

Houston, Texas, 77031, United States

Location

Related Publications (1)

  • Arlinghaus KR, O'Connor DP, Ledoux TA, Hughes SO, Johnston CA. A staged approach to address youth unresponsive to initial obesity intervention: a randomized clinical trial. Int J Obes (Lond). 2021 Dec;45(12):2585-2590. doi: 10.1038/s41366-021-00940-0. Epub 2021 Aug 20.

    PMID: 34417553DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Craig A Johnston, PhD

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

August 20, 2018

Primary Completion

May 1, 2020

Study Completion

September 1, 2021

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)