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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Brown University
Creighton University
Georgetown University
Harvard School of Public Health
Oregon Health and Science University
University of Alabama at Birmingham
University of Iowa
University of Louisville
University of Pennsylvania
Information provided by (Responsible Party):
Judith Ockene, University of Massachusetts, Worcester

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
University of Massachusetts, Worcester
National Cancer Institute (NCI)
Brown University
Creighton University
Georgetown University
Harvard School of Public Health
Oregon Health and Science University
University of Alabama at Birmingham
University of Iowa
University of Louisville
University of Pennsylvania
Investigators
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Principal Investigator: Judith K Ockene, PhD University of Massachusetts, Worcester
Publications:

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Responsible Party: Judith Ockene, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02725905    
Other Study ID Numbers: 6730
1R01CA194787-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators plan to share data through the project website, publications, and presentations to key organizations. The plan is also to share the use of research tools, such as surveys, OSCE cases, and curricula materials, developed over the course of the study. At this time there is no plan to make individual participant data (IPD) available.
Keywords provided by Judith Ockene, University of Massachusetts, Worcester:
Weight Management Counseling
Medical School Education