Advancing Biopsychosocial Care Training Initiative (ABC Initiative)

The Washington University

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07049861

5R01DK134961 (U.S. NIH Grant/Contract)

202406146

Details and patient eligibility

About

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.

Enrollment: 6,200 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,200 participants in 2 patient groups

CMOC

Active Comparator group

Description:

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.

Treatment:

Other: Comprehensive Multidisciplinary Obesity Care

IAUC

Active Comparator group

Description:

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.

Treatment:

Other: Comprehensive Multidisciplinary Obesity Care

Other: Implementation as Usual Control