Weight Management Counseling in Medical Schools (MSWEIGHT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02725905|
Recruitment Status : Active, not recruiting
First Posted : April 1, 2016
Last Update Posted : January 22, 2021
Eight U.S. medical schools will be participating in the study: Weight Management Counseling in Medical Schools, also known as MSWEIGHT. This is a five-year randomized controlled trial (RCT) designed to compare the efficacy of two approaches to learning weight management counseling: 1)traditional education (TE) and; 2) multi-modal educational intervention (MME).
The study aims are to refine and compare the efficacy of MME to TE on observed student weight management counseling skills measured through the primary outcome, the Objective Structured Clinical Examination (OSCE).
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Multi-Modal Education (MME) Behavioral: Traditional Education (TE)||Not Applicable|
Eight U.S. medical schools are matched and then randomized to one of two educational interventions, MME or TE.
Schools randomized to TE represent "usual care" and will continue the current curriculum. The MME arm will build upon the traditional usual curriculum at the medical school. The MME is a multi-modal educational intervention of a series of interactive learning components focused on integrated weight management counseling. This MME intervention for weight management counseling uses the 5As model based on the updated American Heart Association (AHA) /American College of Cardiology (ACC) /The Obesity Society (TOS) and updated NHLBI guidelines.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3199 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Weight Management Counseling in Medical Schools: A Randomized Controlled Trial|
|Actual Study Start Date :||December 1, 2015|
|Actual Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2021|
Experimental: Multi-Modal Education (MME)
1) The MME is a three year multi-modal educational intervention including a series of interactive learning components and interventions focused on integrated weight management counseling. Prior to its launch, each component of the curriculum will be refined using a school participatory approach to help ensure feasibility and acceptability.
Behavioral: Multi-Modal Education (MME)
The MME curriculum focuses on developing weight management counseling (WMC) skills through several components: 1) a web course focused on WMC knowledge and clinical skill competencies; 2) WMC role-play exercises for an opportunity to use an algorithm to practice patient-centered WMC; 3) personal weight management exercises to increase awareness of "Assist" activities (e.g. daily food monitoring using mobile apps, etc); 4) obesity bias assessments, video, and discussions to modify attitudes of implicit weight bias; 5) a formative web-based encounter to interact with and receive feedback from a standardized patient; and 6) an enhanced clerkship rotation focusing on providing learning to preceptors and allowing students to observe preceptors counseling patients who are overweight or obese.
Other Name: MME
Active Comparator: Traditional Education (TE)
2) The TE arm of the study includes the school's current curriculum which may include topics related to the treatment of weight management and obesity.
Behavioral: Traditional Education (TE)
Current curriculum may consist of topics related to biology, population health, or counseling skills. TE also may include sporadic stand-alone lectures or small group discussions conducted separately or as a part of a patient interviewing or behavioral course.
Other Name: TE
- Mean Score on Objective Structured Clinical Exam (OSCE); MME and TE students will be compared regarding the mean score. [ Time Frame: Up to 2 years ]The primary outcome is the OSCE, the standard method for evaluating medical students' skill level at U.S. medical schools. The investigators will compare the efficacy of MME to TE on weight management counseling skills assessed among two separate 3rd year student classes (pre and post MSWeight implementation). MME and TE students will be compared regarding the mean score.
- Mean self-efficacy score on 5As will be calculated as the mean of student's self-reported skill level (1=not at all skilled through 4=very skilled) on 7 items regarding patient counseling skills. [ Time Frame: Up to Three Years ]Perceived self-efficacy skill on 5As (Ask, Advise, Assess, Assist, Arrange) will be assessed longitudinally as 1st Year medical students and then again as 3rd Year medical students. The investigators will compare the difference in self-efficacy between MME and TE. Mean self-efficacy score on 5As will be calculated as the mean of student's self-reported skill level on 7 items about patient counseling skills.
- Percentage of students reporting 3 = moderately skilled or 4 = very skilled will be calculated on 7 items regarding patient counseling skills. [ Time Frame: Upto Three Years ]Perceived self-efficacy skill on 5As (Ask, Advise, Assess, Assist, Arrange) will be assessed longitudinally as 1st Year medical students and then again as 3rd Year medical students. The investigators will compare the percentage of students reporting moderately skilled to very skilled in patient counseling skills in MME and in TE. Percentage of students reporting on self-efficacy will be calculated on 7 items about patient counseling skills.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725905
|United States, Alabama|
|University of Alabama-Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, District of Columbia|
|Georgetown University School of Medicine|
|Washington, District of Columbia, United States, 20007|
|United States, Iowa|
|University of Iowa Carver College of Medicine|
|Iowa City, Iowa, United States, 52242|
|United States, Kentucky|
|University of Louisville School of Medicine|
|Louisville, Kentucky, United States, 40202|
|United States, Nebraska|
|Creighton University School of Medicine|
|Omaha, Nebraska, United States, 68178|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pennsylvania Perelman School of Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02912|
|Principal Investigator:||Judith K Ockene, PhD||University of Massachusetts, Worcester|