Weight Management Counseling in Medical Schools

NCT ID: NCT02725905

Last Updated: 2023-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2022-11-30

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Multi-Modal Education (MME)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Traditional Education (TE)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MME TE

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 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Judith Ockene

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith K Ockene, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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University of Alabama-Birmingham

Birmingham, Alabama, United States

Site Status

Georgetown University School of Medicine

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

Site Status

University of Iowa Carver College of Medicine

Iowa City, Iowa, United States

Site Status

University of Louisville School of Medicine

Louisville, Kentucky, United States

Site Status

Creighton University School of Medicine

Omaha, Nebraska, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Brown University

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21969342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12744909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22775792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16756673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9245677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20165535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20736683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24239920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22622210 (View on PubMed)

Other Identifiers

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1R01CA194787-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6730

Identifier Type: -

Identifier Source: org_study_id

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