Weight Management Counseling in Medical Schools

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Weight Management Counseling in Medical Schools: A Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Multi-Modal Education (MME)
* Behavioral: Traditional Education (TE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The medical school has: Interest in WMC medical education reform. Curricula resources (e.g. academic computing) to facilitate web-course training and a system to maintain student contact. The willingness and ability to incorporate all components of MSWEIGHT into the medical school curriculum, require or strongly encourage students to participate, and award credit for completion. The willingness and ability to offer the WMC OSCE for third year medical students upon completion of the Family or Internal Medicine clerkship rotation. Exclusion Criteria: The medical school does not have: The ability to incorporate all components of MSWEIGHT into the medical school curriculum. The ability to offer the WMC OSCE for third year medical students upon completion of the Family or Internal Medicine clerkship rotation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-Modal Education (MME)<br>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)<br>* 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.<br>* Other names: MME;|
| Active Comparator: Traditional Education (TE)<br>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)<br>* 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.<br>* Other names: TE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Score on Objective Structured Clinical Exam (OSCE); MME and TE students will be compared regarding the mean score. | 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. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to Three Years | 
| Percentage of students reporting 3 = moderately skilled or 4 = very skilled will be calculated on 7 items regarding patient counseling skills. | 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. | Upto Three Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Management Counseling, Medical School Education