Clinical trial NCT06529666: Medical Residents Learning Weight Management Counseling Skills
Official title: MRWeight: Medical Residents Learning Weight Management Counseling Skills -- A Multi-Modal, Technology-Assisted, Spaced Education Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Management
Patient Counseling
Video Communication Asssessments
Keywords: counseling
Internship and Residency
Spaced learning
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Albert Einstein College of Medicine
name: Penn State University
name: The Methodist Hospital Research Institute
name: Boston University
name: Stanford University
name: Temple University
name: University of California, Davis
name: Stony Brook University
First posted: 2024-07-31
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* All PGY1 residents in participating sites

Inclusion Criteria for participating site:

* 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

Primary outcomes:
measure: WMC skills VCA (video Communications assessment) assessment
timeFrame: Completed during month 1 and again at month 12 post recruitment.
measure: Change in WMC skills assessment
timeFrame: Completed during months 1, 12 and 18 post recruitment.
Secondary outcomes:
measure: Change in adoption scale Scores at eighteen months
timeFrame: Completed during months 1, 12 and 18 post recruitment.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: East Setauket
country: United States
facility: Stony Brook
state: New York
city: Hershey
country: United States
facility: Penn State University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: UMass Chan Medical School
name: RAJANI SADASIVAM, PhD
role: PRINCIPAL_INVESTIGATOR
References: