Medical Residents Learning Weight Management Counseling Skills

NCT ID: NCT06529666

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2027-12-30

Brief Summary

The goal of this study is to addresses the lack of weight management training physicians receive during their residency training. The main questions it aims to answer are:

• How affective is the MRWeight curriculum at increasing medical residents weight management counseling (WMC) skills.
• Evaluate residents' adoption of WMC skills in encounters with their patients
• what would be the best way to get residents to adopt the WMC skills Residents in the comparison group will receive a course on obesity and weight management. The residents in the intervention group will have to attend 2 informational sessions and will receive 6 email modules on WMC. Both groups will also take part in 3 assessments over the course of 18 months to see which group has better WMC skills.

Detailed Description

Overweight and obesity have reached epidemic proportions in the United States, proving to be a very difficult health challenge for both patients and the physicians who care for them. Excess weight is a major contributor to heart disease, stroke, and type 2 diabetes. Addressing overweight and obesity in clinical visits is critical to treating and preventing these obesity-associated diseases. However, Weight Management Counseling (WMC) uptake is low, and physicians report lack of training as a critical barrier to WMC. Residency training is a crucial time to influence physicians' current and future practice, yet there is no evidence-supported WMC curriculum for residents. Informed by two pilot studies, MRWeight will use spaced-education to train residents to deliver WMC using the 5As framework (Ask, Advise, Assess, Assist, Arrange) and patient-centered counseling. As such, MRWeight will be delivered in short segments and spaced over 12 months using four components: didactic session 1 - a discussion of WMC foundational concepts; 3Ps program (Prepare, Practice, Process) - an email program using the Video-based Communication Assessment (VCA) to facilitate practice of challenging cases; didactic session 2 - a discussion of key barriers to practicing WMC; and email reinforcement of concepts covered in the preceding components. Each component, guided by Social Cognitive Theory (SCT), is designed to build on and reinforce the training provided by the other components. Using a pair-matched group randomized controlled trial (RCT) including 8 Internal Medicine residency programs, we will test the MRWeight intervention with 3 cohorts of postgraduate year 1 residents followed for 18 months. Comparison arm residents will be emailed the PowerPoint of a foundational course on WMC, but unlike those in the Intervention, comparison sites will not include the didactic sessions or the 3Ps program. Our aims are: Aim 1 will evaluate the effectiveness of the MRWeight Intervention for increasing residents' WMC skills at 12 months; Aim 2 will evaluate residents' self-reported adoption of WMC skills in their encounters with patients in clinical practice at 18 months; Aim 3 will explore possible mechanisms (mediators) and moderators of the intervention's effect on Aim 1 and 2 outcomes (residents' WMC skills and adoption). The study will be the first large trial to test a curriculum that has been integrated into Internal Medicine residency programs for teaching WMC skills. The multi-PIs (Drs. Ockene and Sadasivam) will build on 36-years of successfully conducting large randomized trials to evaluate training programs, including those that taught the 5As and patient-centered counseling for WMC, in 18 medical schools, 10 residency sites, and 10 primary care settings. This study is timely, given public health momentum strongly advocating for physician training and involvement in WMC and the dissemination and implementation of clinical guidelines for obesity treatment.

Conditions

Weight Management Counseling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Comparison Arm

Residents in comparison arm receive a core foundation course and will take part in all 3 assessments (including 3 surveys and 2 video communication assessments) over the course of 18 months.

Group Type: ACTIVE_COMPARATOR

PowerPoint of the foundational course

Intervention Type: BEHAVIORAL

Residents will receive a core foundation slides on weight management counselling

Intervention Arm

Residents in the intervention arm will receive (in addition to the core foundation course) 6 email modules and practice video communication assessments on weight management counseling. They will also attend 2 educational session and take part in all 3 assessments (including 3 surveys and 2 video communication assessments) over the course of 18 months.

Group Type: EXPERIMENTAL

Didatic Session 1: Core Foundation Course

Intervention Type: BEHAVIORAL

A 45-minute foundational presentation covering key Weight Management Counseling (WMC) concepts, obesity bias, and cultural humility facilitated by a trained clinician-educator at the residency program delivered at baseline.

The 3Ps Program

Intervention Type: BEHAVIORAL

6 email modules delivered over months 2-8). Each 3P module will allow the resident to:

(1) Prepare: Review relevant concepts and demonstration videos sent via an email to prepare for completing the VCA vignettes; (2) Practice: Respond to brief vignettes of various 5As WMC challenging scenarios by audio recording their spoken response on the VCA tool; and (3) Process: Reflect on actionable expert and crowdsourced analogue patient feedback on the quality of their responses to each VCA vignette.

Didactic session 2

Intervention Type: BEHAVIORAL

(months 8-10): This 45-minute session will discuss key barriers to WMC adoption in clinical practice using real-world cases captured from residents facilitated by a trained clinician-educator at the residency program.

Email reinforcement

Intervention Type: BEHAVIORAL

2 emails in months 10-12 covering key concepts in the preceding components.

PowerPoint of the foundational course

Intervention Type: BEHAVIORAL

Residents will receive a core foundation slides on weight management counselling

Interventions

Didatic Session 1: Core Foundation Course

A 45-minute foundational presentation covering key Weight Management Counseling (WMC) concepts, obesity bias, and cultural humility facilitated by a trained clinician-educator at the residency program delivered at baseline.

Intervention Type: BEHAVIORAL

The 3Ps Program

6 email modules delivered over months 2-8). Each 3P module will allow the resident to:

(1) Prepare: Review relevant concepts and demonstration videos sent via an email to prepare for completing the VCA vignettes; (2) Practice: Respond to brief vignettes of various 5As WMC challenging scenarios by audio recording their spoken response on the VCA tool; and (3) Process: Reflect on actionable expert and crowdsourced analogue patient feedback on the quality of their responses to each VCA vignette.

Intervention Type: BEHAVIORAL

Didactic session 2

(months 8-10): This 45-minute session will discuss key barriers to WMC adoption in clinical practice using real-world cases captured from residents facilitated by a trained clinician-educator at the residency program.

Intervention Type: BEHAVIORAL

Email reinforcement

2 emails in months 10-12 covering key concepts in the preceding components.

Intervention Type: BEHAVIORAL

PowerPoint of the foundational course

Residents will receive a core foundation slides on weight management counselling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All PGY1 residents in participating sites

• The program is willing and able to incorporate the MRWeight program into the PGY1 core curriculum.
• The residency director will allow PGY1s to complete surveys and curriculum evaluations online or in class and to complete a standardized assessment of their knowledge and use of WMC, and
• The site will allow inclusion of three successive cohorts of PGY1s to ensure more than a sufficient number of residents to adequately test the effect of the intervention

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Rajani Sadasivam

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

RAJANI SADASIVAM, PhD

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

UC Davis

Sacramento, California, United States

Site Status: RECRUITING

Boston University

Boston, Massachusetts, United States

Site Status: NOT_YET_RECRUITING

Stony Brook

East Setauket, New York, United States

Site Status: RECRUITING

Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status: RECRUITING

Penn State University

Hershey, Pennsylvania, United States

Site Status: RECRUITING

Temple University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Houston Methodist

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

RAJANI SADASIVAM, PhD

Role: CONTACT

Rajani.Sadasivam@umassmed.edu

(508) 856-8989 ext. 68923

Facility Contacts

Kim Chiang, MD

Role: primary

kichiang@stanford.edu

650-498-9000

Stephany Sanchez, MD

Role: primary

stesanchez@UCDAVIS.EDU

800-282-3284

Juhee McDougal, MD

Role: primary

jcmcd@bu.edu

617-414-5951

Patricia NG, MD

Role: primary

Patricia.Ng@stonybrookmedicine.edu

631-444-4630

Jing Yu Pan, MD

Role: primary

jpan1@montefiore.org

718-920-2273

Eliana Hempel, MD

Role: primary

ehempel@pennstatehealth.psu.edu

717-531-5160

Sharon Herring, MD, MPH

Role: primary

sharon.herring@temple.edu

800-836-7536

Melina Awar, MD

Role: primary

mawar@houstonmethodist.org

713-441-0006

Other Identifiers

1R01DK134372-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000691

Identifier Type: -

Identifier Source: org_study_id