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Recruiting NCT07049861

Advancing Biopsychosocial Care Training Initiative

No phase Interventional Weight Management Obesity Prevention Obesity and Obesity-related Medical Conditions Obesity and Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Multidisciplinary Obesity Care, Implementation as Usual Control.
Who it may be relevant to
Registry conditions: Weight Management, Obesity Prevention, Obesity and Obesity-related Medical Conditions, Obesity and Overweight. Basic parameters: from 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Increasing Access to USPSTF-Recommended Obesity Care for Youth and Adults Who Are Recipients of Medicaid: Evaluation of a Comprehensive Multidisciplinary Obesity Care Training Program in FQHCs

Overview

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.

Interventions

  • Other 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 provider
  • Other Implementation as Usual Control
    The standard of care implemented in FQHCs in the absence of CMOC training.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT07049861 · 202406146 · 5R01DK134961

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗