Weight Management Counseling in Medical Schools (MSWEIGHT)

Weight Management Counseling in Medical Schools: A Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Multi-Modal Education (MME); Behavioral: Traditional Education (TE)

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.

• Study Type: Interventional
• Enrollment (Actual): 3199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama-Birmingham
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University School of Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Carver College of Medicine
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Creighton University School of Medicine
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Perelman School of Medicine
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: TE

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Cancer Institute (NCI); University of Pennsylvania; University of Alabama at Birmingham; Georgetown University; Brown University; University of Iowa; Oregon Health and Science University; Creighton University; University of Louisville; Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Judith K Ockene, PhD, University of Massachusetts, Worcester

Publications and helpful links

General Publications

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3029-3030.
• Leblanc ES, O'Connor E, Whitlock EP, Patnode CD, Kapka T. Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2011 Oct 4;155(7):434-47. doi: 10.7326/0003-4819-155-7-201110040-00006.
• Block JP, DeSalvo KB, Fisher WP. Are physicians equipped to address the obesity epidemic? Knowledge and attitudes of internal medicine residents. Prev Med. 2003 Jun;36(6):669-75. doi: 10.1016/s0091-7435(03)00055-0.
• Vitolins MZ, Crandall S, Miller D, Ip E, Marion G, Spangler JG. Obesity educational interventions in U.S. medical schools: a systematic review and identified gaps. Teach Learn Med. 2012;24(3):267-72. doi: 10.1080/10401334.2012.692286.
• Forman-Hoffman V, Little A, Wahls T. Barriers to obesity management: a pilot study of primary care clinicians. BMC Fam Pract. 2006 Jun 6;7:35. doi: 10.1186/1471-2296-7-35.
• Kristeller JL, Hoerr RA. Physician attitudes toward managing obesity: differences among six specialty groups. Prev Med. 1997 Jul-Aug;26(4):542-9. doi: 10.1006/pmed.1997.0171.
• Davis NJ, Shishodia H, Taqui B, Dumfeh C, Wylie-Rosett J. Resident physician attitudes and competence about obesity treatment: need for improved education. Med Educ Online. 2008 May 2;13:5. doi: 10.3885/meo.2008.Res00257.
• Adams KM, Kohlmeier M, Zeisel SH. Nutrition education in U.S. medical schools: latest update of a national survey. Acad Med. 2010 Sep;85(9):1537-42. doi: 10.1097/ACM.0b013e3181eab71b.
• Chisholm A, Hart J, Mann KV, Harkness E, Peters S. Preparing medical students to facilitate lifestyle changes with obese patients: a systematic review of the literature. Acad Med. 2012 Jul;87(7):912-23. doi: 10.1097/ACM.0b013e3182580648.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Weight Management Counseling; Medical School Education
• Other Study ID Numbers: 6730; 1R01CA194787-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.