ObesityMSWEIGHTNCT02725905
Weight Management Counseling in Medical Schools
A study testing Multi-Modal Education (MME) and Traditional Education (TE) in people with Obesity, run by University of Massachusetts, Worcester at 8 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Multi-Modal Education (MME) and Traditional Education (TE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,199 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Dec 2015to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama-Birmingham
Birmingham, Alabama, 35294
University of Iowa Carver College of Medicine
Iowa City, Iowa, 52242
University of Louisville School of Medicine
Louisville, Kentucky, 40202
Creighton University School of Medicine
Omaha, Nebraska, 68178
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
Brown University
Providence, Rhode Island, 02912
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20007
About this study
Official title: 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).
Read the 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.
- Conditions
- Obesity
- Being tested
- Multi-Modal Education (MME), Traditional Education (TE)
- Keywords
- Weight Management Counseling, Medical School Education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Modal Education (MME)Behavioural
Also called 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.
Traditional Education (TE)Behavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional Education (TE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: Upto Three Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start1 Dec 2015
- Primary completion30 Nov 2020
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Brown University, Creighton University, Georgetown University, Harvard School of Public Health (HSPH), Oregon Health and Science University, University of Alabama at Birmingham, University of Iowa, University of Louisville, University of Pennsylvania
- Responsible party
- Principal investigator, Judith Ockene, University of Massachusetts, Worcester
- Investigators
- Judith K Ockene, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725905
- Sponsor's protocol ID
- 6730
- Other IDs
- 1R01CA194787-01A1
- Acronym
- MSWEIGHT
- Status last verified
- May 2023
- First submitted
- 3 Mar 2016
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 21969342Block 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.
PubMed 12744909Vitolins 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.
PubMed 22775792Forman-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.
PubMed 16756673Kristeller 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.
PubMed 9245677Davis 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.
PubMed 20165535Adams 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.
PubMed 20736683Jensen 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.
PubMed 24239920Chisholm 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.
PubMed 22622210
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management Counseling in Medical Schools: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02725905
- Acronym / sponsor ID
- MSWEIGHT / 6730
- Conditions
- Obesity
- Keywords
- Weight Management Counseling, Medical School Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,199 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Brown University, Creighton University, Georgetown University, Harvard School of Public Health (HSPH), Oregon Health and Science University, University of Alabama at Birmingham, University of Iowa, University of Louisville, University of Pennsylvania
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Modal Education (MME) | Experimental | Behavioral: 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. |
| Traditional Education (TE) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Modal Education (MME)Also: MMEThe 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. | Behavioural | Multi-Modal Education (MME) |
| Traditional Education (TE)Also: TECurrent 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. | Behavioural | Traditional Education (TE) |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Background: PubMed 21969342Leblanc 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.
- Background: PubMed 12744909Block 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.
- Background: PubMed 22775792Vitolins 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.
- Background: PubMed 16756673Forman-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.
- Background: PubMed 9245677Kristeller 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.
- Background: PubMed 20165535Davis 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.
- Background: PubMed 20736683Adams 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.
- Background: PubMed 24239920Jensen 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.
- Background: PubMed 22622210Chisholm 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith K Ockene, PhD principal investigator
University of Massachusetts, Worcester
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Modal Education (MME) and Traditional Education (TE) in people with Obesity, run by University of Massachusetts, Worcester at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725905, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.