Recruiting

Weight Management

Sponsor:

Oregon Health and Science University

Code:

NCT05950620

Conditions

Obesity, Childhood

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Medical obesity management.

Study Details

Brief summary:

This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.

Conditions

Obesity, Childhood

Study ID

NCT05950620

Start date

Jul 1, 2022

Status verified date

Jul, 2023

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

Children with obesity (BMI > 30 kg/m2 or > 95th percentile) or in need of weight management of unwanted weight gain.

Exclusion Criteria:

None.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Intervention

Pediatric patients with obesity or in need of weight management for unwanted weight gain.

Controls

Historic controls matched to the Intervention group on age, sex, and BMI percentile.

Interventions

Medical obesity management.

Dietician visits, education, anti-obesity medications, and/or referral for metabolic-bariatric surgery as indicated by American Academy of Pediatrics guidelines for obesity management.

Primary outcome measure

  • Change in body weight [ Time Frame: Baseline to follow-up (1-3 years) ]
  • Change in body height [ Time Frame: Baseline to follow-up (1-3 years) ]
  • Change in BMI [ Time Frame: Baseline to follow-up (1-3 years) ]
  • Impact on glucose control [ Time Frame: Baseline to follow-up (1-3 years) ]
  • Impact on fatty liver [ Time Frame: Baseline to follow-up (1-3 years) ]
  • Impact on lipid levels [ Time Frame: Baseline to follow-up (1-3 years) ]

Central Contacts and Locations

Central contacts

Jonathan Q Purnell, MD

503-494-1056purnellj@ohsu.edu

Locations

The Children's Clinic

Recruiting

Portland, Oregon, United States, 97225

Contacts

Susanne Purnell

503-297-3371spurnell@childrens-clinic.com

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jul 19, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2023-07-19.