Advancing Biopsychosocial Care Training Initiative

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07049861
Status
Recruiting
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Conditions

  • Obesity
  • Obesity Prevention
  • Obesity and Obesity-related Medical Conditions
  • Obesity and Overweight
  • Weight Management

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Comprehensive Multidisciplinary Obesity Care — OTHER
    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 — OTHER
    The standard of care implemented in FQHCs in the absence of CMOC training.

Study Details

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.

Key Dates

Start date
Jul 14, 2025
Status verified
May 2026
Primary completion
Dec 15, 2028
Completion
Dec 15, 2028

Study Design

Enrollment
6,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Aubrie Hampp, MSc
[email protected]
314-662-2005
Corinne McMahon, MS, RDN, LD
[email protected]
Denise Wilfley, Ph.D. (PRINCIPAL_INVESTIGATOR)

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