Advancing Biopsychosocial Care Training Initiative

NCT07049861 | Recruiting

• 2 other identifiers: 2024061465R01DK134961
• Study Type: interventional
• Target: 6,200
• Locations: 1 country
• Sites: 1

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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in patient percent overweight

  Percent over the median body mass index (BMI) for sex and age.

  Months 2-29 post-enrollment

Study Arms (2)

CMOC

ACTIVE COMPARATOR

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.

Other: Comprehensive Multidisciplinary Obesity Care

IAUC

ACTIVE COMPARATOR

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.

Other: Comprehensive Multidisciplinary Obesity Care; Other: Implementation as Usual Control

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.

Also known as: Core+

CMOC; IAUC

Implementation as Usual Control OTHER

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

Also known as: Core

IAUC

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Missouri Department of Social Services, MO HealthNet Division, Office of Transformation: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Children's Mercy Hospital Kansas City: collaborator
• University of Missouri-Columbia: collaborator
• Missouri Institute of Mental Health: collaborator
• University of Missouri, Kansas City: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Denise Wilfley, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aubrie Hampp, MSc

CONTACT

314-662-2005; ahampp@wustl.edu

Corinne McMahon, MS, RDN, LD

CONTACT

cnmcmahon@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)