Weight ManagementABC InitiativeNCT07049861
Advancing Biopsychosocial Care Training Initiative
A study testing Comprehensive Multidisciplinary Obesity Care in people with Weight Management and Obesity Prevention, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Management, Obesity Prevention, Obesity and Obesity-related Medical Conditions
- What is being tested?
- Comprehensive Multidisciplinary Obesity Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 15 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- Patients not on Medicaid
- Youth under the age of 5
- Not a patient at a participating clinic
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Corinne McMahon, MS, RDN, LD contact
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Aubrie Hampp, MSc, 314-273-9184, ahampp@wustl.edu
Corinne McMahon, MS, RDN, LD, cnmcmahon@wustl.edu
About this study
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
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
- Being tested
- Comprehensive Multidisciplinary Obesity Care, Implementation as Usual Control
- Keywords
- Training, Implementation, Intensive Behavioral Treatment, Family-based Behavioral Treatment, Obesity, Obesity Care
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Multidisciplinary Obesity CareOther
Also called Core+
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 ControlOther
Also called Core
The standard of care implemented in FQHCs in the absence of CMOC training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Comprehensive Multidisciplinary Obesity Care; Other: Implementation as Usual Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient percent overweight
Percent over the median body mass index (BMI) for sex and age.
Measured: Months 2-29 post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start14 Jul 2025
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Mercy Hospital Kansas City, University of Missouri-Columbia, Missouri Institute of Mental Health, University of Missouri, Kansas City, The Missouri Department of Social Services, MO HealthNet Division, Office of Transformation
- Responsible party
- Sponsor
- Investigators
- Denise Wilfley, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049861
- Sponsor's protocol ID
- 202406146
- Other IDs
- 5R01DK134961
- Acronym
- ABC Initiative
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07049861
- Acronym / sponsor ID
- ABC Initiative / 202406146
- Conditions
- Weight Management, Obesity Prevention, Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Obesity
- Keywords
- Training, Implementation, Intensive Behavioral Treatment, Family-based Behavioral Treatment, Obesity, Obesity Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,200 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Mercy Hospital Kansas City, University of Missouri-Columbia, Missouri Institute of Mental Health, University of Missouri, Kansas City, The Missouri Department of Social Services, MO HealthNet Division, Office of Transformation
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMOC | Active comparator | Other: Comprehensive Multidisciplinary Obesity CareThe 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. |
| IAUC | Active comparator | Other: Comprehensive Multidisciplinary Obesity Care, Other: Implementation as Usual ControlThe 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Multidisciplinary Obesity CareAlso: Core+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. | Other | CMOC, IAUC |
| Implementation as Usual ControlAlso: CoreThe standard of care implemented in FQHCs in the absence of CMOC training. | Other | IAUC |
Primary outcome
Change in patient percent overweight
Time frame: Months 2-29 post-enrollment
Percent over the median body mass index (BMI) for sex and age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corinne McMahon, MS, RDN, LD contact
Denise Wilfley, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Multidisciplinary Obesity Care in people with Weight Management and Obesity Prevention, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aubrie Hampp, MSc (314-662-2005, ahampp@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient percent overweight (time frame: Months 2-29 post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.