Recruiting

Obesity Care

Sponsor:

Washington University School of Medicine

Code:

NCT07049861

Conditions

Weight Management

Obesity Prevention

Obesity and Obesity-related Medical Conditions

Obesity and Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Interventions

Comprehensive Multidisciplinary Obesity Care

Implementation as Usual Control

Study Details

Brief summary:

This project will compare two training approaches for US Preventive Services Task Force recommended obesity care in Federally Qualified Health Centers (FQHC) across four aims. Aim 1 compares patient-level effectiveness \[i.e., patient relative weight change and the proportion of patients who achieve clinically significant weight loss\]. Aim 2 compares reach (patient treatment utilization). Aim 3 compares primary care provider (PCP) referrals to USPSTF-recommended care at 12 (adoption) and 24 months (maintenance) and short- and long-term changes in provider obesity care competencies . Aim 4 compares implementation and service costs.

Conditions

Weight Management

Obesity Prevention

Obesity and Obesity-related Medical Conditions

Obesity and Overweight

Obesity

Study ID

NCT07049861

Start date

Jul 14, 2025

Status verified date

Aug, 2026

Completion date

Dec 15, 2028

Anticipated

Primary completion date

Dec 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Study Eligibility Criteria - Provider Trainees:

  • Provider Trainees must be PCPs, BHPs, RDNs, or CHWs who work at participating clinics.

  • PCPs that are eligible to participate as Provider Trainees can be any of the following: Medical Doctors (MD), Doctor of Osteopathic Medicine (DO), Physician Assistants (PA), or Nurse Practitioners (NP). PCPs must see patients in a primary care setting and be capable of referring patients to IBT and MNT. PCPs must have already completed their residency (when applicable).
  • BHPs that are eligible to participate as Provider Trainees must be at least one of the following categories (listed with typical credentials): Licensed Clinical Social Worker (LCSW), Licensed Professional Counselor (LPC), Licensed Marriage and Family Therapist (LMFT), Psychologist (PhD/PsyD), Psychiatric Nurse Practitioner, Psychiatrist (MD).
  • RDNs that are eligible to participate as Provider Trainees must be Registered Dietitians/Registered Dietitian Nutritionists.
  • CHWs must work as Community Health Workers, or in functionally similar role, within participating clinics

Study Eligibility - EHR Patients: Benefit-Eligible Patients from Participating Clinics

  • Benefit-Eligible Patients from Participating Clinics can either be youth (ages 5-20) or adults (ages 21+) and must be recipients of Medicaid, eligible for the MO Medicaid benefit (i.e., Medicaid recipients with obesity), and have been seen at participating FQHC clinics.

Exclusion Criteria - Provider Trainees:

  • Not at a participating clinic
  • PCPs who do not have the ability to refer to IBT or MNT
  • Resident Doctors
  • A doctor specializing in reproductive health (or related fields)

Exclusion Criteria - Benefit-Eligible Patients from Participating Clinics:

  • Patients without obesity
  • Patients not on Medicaid
  • Youth under the age of 5
  • Not a patient at a participating clinic

Study Design

Enrollment

6200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: CMOC

The Provider Trainees at the Federally Qualified Health Centers (FQHCs) assigned to the Comprehensive Multidisciplinary Obesity Care (CMOC) condition will receive the CMOC Training during the12-month training period (months 0-12) of the trial, followed by a 12-month (month 13-24) sustainability period.

active comparator: IAUC

The Provider Trainees at the Federally Qualified Health Centers (FQHCs) in the implementation as usual control (IAUC) condition will receive the IAUC Training during the12-month training period (months 0-12) of the trial, followed by a 12-month (month 13-24) sustainability period. Following the 12-month sustainability period, Provider Trainees will be offered the CMOC Training.

Interventions

Comprehensive Multidisciplinary Obesity Care

CMOC is an innovative approach to obesity care delivery that leverages policy, clinical and community linkages, and digital technology for scalability. CMOC involves training providers (medical providers, registered dietitians, and behavioral health providers) to deliver guideline-based obesity care for youth and adults with obesity who receive Medicaid. Guidelines-based care involves screening, identification, weight counseling, and referral to intensive behavioral treatment by medical providers, and delivery of multicomponent intensive behavioral treatment by behavioral health providers and registered dietitians.

Implementation as Usual Control

The standard of care implemented in FQHCs in the absence of CMOC training.

Primary outcome measure

  • Change in patient percent overweight [ Time Frame: Months 2-29 post-enrollment ]

Central Contacts and Locations

Central contacts

Aubrie Hampp, MSc

314-662-2005ahampp@wustl.edu

Corinne McMahon, MS, RDN, LD

cnmcmahon@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Aubrie Hampp, MSc

314-273-9184ahampp@wustl.edu

Corinne McMahon, MS, RDN, LD

cnmcmahon@wustl.edu

Principal Investigator:

Denise Wilfley, Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Training
  • Implementation
  • Intensive Behavioral Treatment
  • Family-based Behavioral Treatment
  • Obesity
  • Obesity Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-10.