Weight Management Counseling in Medical Schools

NCT02725905 | Completed DMC

• 2 other identifiers: 67301R01CA194787-01A1
• Study Type: interventional
• Target: 3,199
• Locations: 1 country
• Sites: 8

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).

Conditions

Obesity

Keywords

Weight Management Counseling; Medical School Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  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.

  Upto Three Years

Study Arms (2)

Multi-Modal Education (MME)

EXPERIMENTAL

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)

Traditional Education (TE)

ACTIVE COMPARATOR

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)

Interventions

Multi-Modal Education (MME) BEHAVIORAL

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.

Also known as: MME

Multi-Modal Education (MME)

Traditional Education (TE) BEHAVIORAL

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.

Also known as: TE

Traditional Education (TE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Cancer Institute (NCI): collaborator
• Brown University: collaborator
• Creighton University: collaborator
• Georgetown University: collaborator
• Harvard School of Public Health (HSPH): collaborator
• Oregon Health and Science University: collaborator
• University of Alabama at Birmingham: collaborator
• University of Iowa: collaborator
• University of Louisville: collaborator
• University of Pennsylvania: collaborator

Study Sites (8)

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Georgetown University School of Medicine

Washington D.C., District of Columbia, 20007, United States

Location

University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

University of Louisville School of Medicine

Louisville, Kentucky, 40202, United States

Location

Creighton University School of Medicine

Omaha, Nebraska, 68178, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (9)

• 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.

  PMID: 21969342 BACKGROUND

• 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.

  PMID: 12744909 BACKGROUND

• 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.

  PMID: 22775792 BACKGROUND

• 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.

  PMID: 16756673 BACKGROUND

• 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.

  PMID: 9245677 BACKGROUND

• 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.

  PMID: 20165535 BACKGROUND

• 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.

  PMID: 20736683 BACKGROUND

• 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.

  PMID: 24239920 BACKGROUND

• 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.

  PMID: 22622210 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

MME

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith K Ockene, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 1, 2016
• Study Start: December 1, 2015
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)