Weight Management CounselingMRWeightNCT06529666
Medical Residents Learning Weight Management Counseling Skills
A study testing Didatic Session 1: Core Foundation Course, The 3Ps Program and Didactic session 2 in people with Weight Management Counseling, run by University of Massachusetts, Worcester at 8 sites in United States.
Trial summary
The goal of this study is to addresses the lack of weight management training physicians receive during their residency training. The main questions it aims to answer are: How affective is the MRWeight curriculum at increasing medical residents weight management counseling (WMC) skills. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Management Counseling
- What is being tested?
- Didatic Session 1: Core Foundation Course, The 3Ps Program and Didactic session 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Jun 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All PGY1 residents in participating sites
- The program is willing and able to incorporate the MRWeight program into the PGY1 core curriculum.
- The residency director will allow PGY1s to complete surveys and curriculum evaluations online or in class and to complete a standardized assessment of their knowledge and use of WMC, and
- The site will allow inclusion of three successive cohorts of PGY1s to ensure more than a sufficient number of residents to adequately test the effect of the intervention
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
Boston University
Boston, Massachusetts, 02118
Juhee McDougal, MD, (617) 414-5951, jcmcd@bu.edu
Juhee McDougal, MD
- Recruiting
Stony Brook
East Setauket, New York, 11733
Patricia NG, MD, 631-444-4630, Patricia.Ng@stonybrookmedicine.edu
Patricia NG, MD
- Recruiting
Penn State University
Hershey, Pennsylvania, 17033
Eliana Hempel, MD, 717-531-5160, ehempel@pennstatehealth.psu.edu
Eliana Hempel, MD
- Recruiting
Houston Methodist
Houston, Texas, 77030
Melina Awar, MD, 713-441-0006, mawar@houstonmethodist.org
Melina Awar, MD
- Recruiting
Stanford University
Palo Alto, California, 94304
Kim Chiang, MD, 650-498-9000, kichiang@stanford.edu
Kim Chiang, MD
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Sharon Herring, MD, MPH, 800-836-7536, sharon.herring@temple.edu
Sharon Herring, MD,MPH
- Recruiting
UC Davis
Sacramento, California, 95820
Stephany Sanchez, MD, 800-282-3284, stesanchez@UCDAVIS.EDU
Stephany Sanchez, MD
- Recruiting
Albert Einstein College of Medicine
The Bronx, New York, 10467
Jing Yu Pan, MD, (718) 920-2273, jpan1@montefiore.org
Jing Yu Pan, MD
About this study
Official title: MRWeight: Medical Residents Learning Weight Management Counseling Skills -- A Multi-Modal, Technology-Assisted, Spaced Education Program
The goal of this study is to addresses the lack of weight management training physicians receive during their residency training. The main questions it aims to answer are:
- How affective is the MRWeight curriculum at increasing medical residents weight management counseling (WMC) skills.
- Evaluate residents' adoption of WMC skills in encounters with their patients
- what would be the best way to get residents to adopt the WMC skills Residents in the comparison group will receive a course on obesity and weight management. The residents in the intervention group will have to attend 2 informational sessions and will receive 6 email modules on WMC. Both groups will also take part in 3 assessments over the course of 18 months to see which group has better WMC skills.
Read the detailed description
Overweight and obesity have reached epidemic proportions in the United States, proving to be a very difficult health challenge for both patients and the physicians who care for them. Excess weight is a major contributor to heart disease, stroke, and type 2 diabetes. Addressing overweight and obesity in clinical visits is critical to treating and preventing these obesity-associated diseases. However, Weight Management Counseling (WMC) uptake is low, and physicians report lack of training as a critical barrier to WMC. Residency training is a crucial time to influence physicians' current and future practice, yet there is no evidence-supported WMC curriculum for residents. Informed by two pilot studies, MRWeight will use spaced-education to train residents to deliver WMC using the 5As framework (Ask, Advise, Assess, Assist, Arrange) and patient-centered counseling. As such, MRWeight will be delivered in short segments and spaced over 12 months using four components: didactic session 1 - a discussion of WMC foundational concepts; 3Ps program (Prepare, Practice, Process) - an email program using the Video-based Communication Assessment (VCA) to facilitate practice of challenging cases; didactic session 2 - a discussion of key barriers to practicing WMC; and email reinforcement of concepts covered in the preceding components. Each component, guided by Social Cognitive Theory (SCT), is designed to build on and reinforce the training provided by the other components. Using a pair-matched group randomized controlled trial (RCT) including 8 Internal Medicine residency programs, we will test the MRWeight intervention with 3 cohorts of postgraduate year 1 residents followed for 18 months. Comparison arm residents will be emailed the PowerPoint of a foundational course on WMC, but unlike those in the Intervention, comparison sites will not include the didactic sessions or the 3Ps program. Our aims are: Aim 1 will evaluate the effectiveness of the MRWeight Intervention for increasing residents' WMC skills at 12 months; Aim 2 will evaluate residents' self-reported adoption of WMC skills in their encounters with patients in clinical practice at 18 months; Aim 3 will explore possible mechanisms (mediators) and moderators of the intervention's effect on Aim 1 and 2 outcomes (residents' WMC skills and adoption). The study will be the first large trial to test a curriculum that has been integrated into Internal Medicine residency programs for teaching WMC skills. The multi-PIs (Drs. Ockene and Sadasivam) will build on 36-years of successfully conducting large randomized trials to evaluate training programs, including those that taught the 5As and patient-centered counseling for WMC, in 18 medical schools, 10 residency sites, and 10 primary care settings. This study is timely, given public health momentum strongly advocating for physician training and involvement in WMC and the dissemination and implementation of clinical guidelines for obesity treatment.
- Conditions
- Weight Management Counseling
- Being tested
- Didatic Session 1: Core Foundation Course, The 3Ps Program, Didactic session 2, Email reinforcement, PowerPoint of the foundational course
- Keywords
- weight management counseling, Internship and Residency, skills and adoption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Didatic Session 1: Core Foundation CourseBehavioural
A 45-minute foundational presentation covering key Weight Management Counseling (WMC) concepts, obesity bias, and cultural humility facilitated by a trained clinician-educator at the residency program delivered at baseline.
The 3Ps ProgramBehavioural
6 email modules delivered over months 2-8). Each 3P module will allow the resident to:
(1) Prepare: Review relevant concepts and demonstration videos sent via an email to prepare for completing the VCA vignettes; (2) Practice: Respond to brief vignettes of various 5As WMC challenging scenarios by audio recording their spoken response on the VCA tool; and (3) Process: Reflect on actionable expert and crowdsourced analogue patient feedback on the quality of their responses to each VCA vignette.
Didactic session 2Behavioural
(months 8-10): This 45-minute session will discuss key barriers to WMC adoption in clinical practice using real-world cases captured from residents facilitated by a trained clinician-educator at the residency program.
Email reinforcementBehavioural
2 emails in months 10-12 covering key concepts in the preceding components.
PowerPoint of the foundational courseBehavioural
Residents will receive a core foundation slides on weight management counselling
| Study group | Role | What they receive |
|---|---|---|
| Comparison Arm | Active comparator | Residents in comparison arm receive a core foundation course and will take part in all 3 assessments (including 3 surveys and 2 video communication assessments) over the course of 18 months. Receives: Behavioral: PowerPoint of the foundational course |
| Intervention Arm | Experimental | Residents in the intervention arm will receive (in addition to the core foundation course) 6 email modules and practice video communication assessments on weight management counseling. They will also attend 2 educational session and take part in all 3 assessments (including 3 surveys and 2 video communication assessments) over the course of 18 months. Receives: Behavioral: Didatic Session 1: Core Foundation Course; Behavioral: The 3Ps Program; Behavioral: Didactic session 2; Behavioral: Email reinforcement; Behavioral: PowerPoint of the foundational course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WMC skills assessment
Description: This measure will be assessed using an online survey administered the end of the first cohort (around the end of the residents' PGY1).
Measured: Completed during month 1 and again at around 9-12 months post recruitment.
WMC skills VCA (video Communications assessment) assessment
Residents in both arms will be asked to complete the assessment VCA vignettes that will include a series of vignettes representing challenging cases. Trained raters blinded to the residents' study arm (intervention vs. comparison) will rate the residents' responses.
Measured: Completed during months 1 and again at around 9-12 months post recruitment.
Secondary outcomes (1)
Change in adoption scale Scores at eighteen months
This measure will be assessed using Adoption scale (7-item checklist assessing resident adoption of WMC skills in their encounters with patients in clinical practice) on a 5-point on a Likert Scale [never (0) to always (4)].
Measured: Completed during months 1, 12 and 18 post recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start10 Jun 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight Management CounselingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Albert Einstein College of Medicine, Penn State University, The Methodist Hospital Research Institute, Boston University, Stanford University, Temple University, University of California, Davis, Stony Brook University
- Responsible party
- Principal investigator, Rajani Sadasivam, University of Massachusetts, Worcester
- Investigators
- RAJANI SADASIVAM, PhD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529666
- Sponsor's protocol ID
- STUDY00000691
- Other IDs
- 1R01DK134372-01
- Acronym
- MRWeight
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRWeight: Medical Residents Learning Weight Management Counseling Skills -- A Multi-Modal, Technology-Assisted, Spaced Education Program
- ClinicalTrials.gov ID
- NCT06529666
- Acronym / sponsor ID
- MRWeight / STUDY00000691
- Conditions
- Weight Management Counseling
- Keywords
- weight management counseling, Internship and Residency, skills and adoption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Albert Einstein College of Medicine, Penn State University, The Methodist Hospital Research Institute, Boston University, Stanford University, Temple University, University of California, Davis, Stony Brook University
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 31 Jul 2024 (actual)
- 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.
The goal of this study is to addresses the lack of weight management training physicians receive during their residency training. The main questions it aims to answer are:
- How affective is the MRWeight curriculum at increasing medical residents weight management counseling (WMC) skills.
- Evaluate residents' adoption of WMC skills in encounters with their patients
- what would be the best way to get residents to adopt the WMC skills Residents in the comparison group will receive a course on obesity and weight management. The residents in the intervention group will have to attend 2 informational sessions and will receive 6 email modules on WMC. Both groups will also take part in 3 assessments over the course of 18 months to see which group has better WMC skills.
Detailed description
Overweight and obesity have reached epidemic proportions in the United States, proving to be a very difficult health challenge for both patients and the physicians who care for them. Excess weight is a major contributor to heart disease, stroke, and type 2 diabetes. Addressing overweight and obesity in clinical visits is critical to treating and preventing these obesity-associated diseases. However, Weight Management Counseling (WMC) uptake is low, and physicians report lack of training as a critical barrier to WMC. Residency training is a crucial time to influence physicians' current and future practice, yet there is no evidence-supported WMC curriculum for residents. Informed by two pilot studies, MRWeight will use spaced-education to train residents to deliver WMC using the 5As framework (Ask, Advise, Assess, Assist, Arrange) and patient-centered counseling. As such, MRWeight will be delivered in short segments and spaced over 12 months using four components: didactic session 1 - a discussion of WMC foundational concepts; 3Ps program (Prepare, Practice, Process) - an email program using the Video-based Communication Assessment (VCA) to facilitate practice of challenging cases; didactic session 2 - a discussion of key barriers to practicing WMC; and email reinforcement of concepts covered in the preceding components. Each component, guided by Social Cognitive Theory (SCT), is designed to build on and reinforce the training provided by the other components. Using a pair-matched group randomized controlled trial (RCT) including 8 Internal Medicine residency programs, we will test the MRWeight intervention with 3 cohorts of postgraduate year 1 residents followed for 18 months. Comparison arm residents will be emailed the PowerPoint of a foundational course on WMC, but unlike those in the Intervention, comparison sites will not include the didactic sessions or the 3Ps program. Our aims are: Aim 1 will evaluate the effectiveness of the MRWeight Intervention for increasing residents' WMC skills at 12 months; Aim 2 will evaluate residents' self-reported adoption of WMC skills in their encounters with patients in clinical practice at 18 months; Aim 3 will explore possible mechanisms (mediators) and moderators of the intervention's effect on Aim 1 and 2 outcomes (residents' WMC skills and adoption). The study will be the first large trial to test a curriculum that has been integrated into Internal Medicine residency programs for teaching WMC skills. The multi-PIs (Drs. Ockene and Sadasivam) will build on 36-years of successfully conducting large randomized trials to evaluate training programs, including those that taught the 5As and patient-centered counseling for WMC, in 18 medical schools, 10 residency sites, and 10 primary care settings. This study is timely, given public health momentum strongly advocating for physician training and involvement in WMC and the dissemination and implementation of clinical guidelines for obesity treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison Arm | Active comparator | Behavioral: PowerPoint of the foundational courseResidents in comparison arm receive a core foundation course and will take part in all 3 assessments (including 3 surveys and 2 video communication assessments) over the course of 18 months. |
| Intervention Arm | Experimental | Behavioral: Didatic Session 1: Core Foundation Course, Behavioral: The 3Ps Program, Behavioral: Didactic session 2, Behavioral: Email reinforcement, Behavioral: PowerPoint of the foundational courseResidents in the intervention arm will receive (in addition to the core foundation course) 6 email modules and practice video communication assessments on weight management counseling. They will also attend 2 educational session and take part in all 3 assessments (including 3 surveys and 2 video communication assessments) over the course of 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All PGY1 residents in participating sites
- The program is willing and able to incorporate the MRWeight program into the PGY1 core curriculum.
- The residency director will allow PGY1s to complete surveys and curriculum evaluations online or in class and to complete a standardized assessment of their knowledge and use of WMC, and
- The site will allow inclusion of three successive cohorts of PGY1s to ensure more than a sufficient number of residents to adequately test the effect of the intervention
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Didatic Session 1: Core Foundation CourseA 45-minute foundational presentation covering key Weight Management Counseling (WMC) concepts, obesity bias, and cultural humility facilitated by a trained clinician-educator at the residency program delivered at baseline. | Behavioural | Intervention Arm |
| The 3Ps Program6 email modules delivered over months 2-8). Each 3P module will allow the resident to: (1) Prepare: Review relevant concepts and demonstration videos sent via an email to prepare for completing the VCA vignettes; (2) Practice: Respond to brief vignettes of various 5As WMC challenging scenarios by audio recording their spoken response on the VCA tool; and (3) Process: Reflect on actionable expert and crowdsourced analogue patient feedback on the quality of their responses to each VCA vignette. | Behavioural | Intervention Arm |
| Didactic session 2(months 8-10): This 45-minute session will discuss key barriers to WMC adoption in clinical practice using real-world cases captured from residents facilitated by a trained clinician-educator at the residency program. | Behavioural | Intervention Arm |
| Email reinforcement2 emails in months 10-12 covering key concepts in the preceding components. | Behavioural | Intervention Arm |
| PowerPoint of the foundational courseResidents will receive a core foundation slides on weight management counselling | Behavioural | Comparison Arm, Intervention Arm |
Primary outcome
Change in WMC skills assessment
Time frame: Completed during month 1 and again at around 9-12 months post recruitment.
Description: This measure will be assessed using an online survey administered the end of the first cohort (around the end of the residents' PGY1).
WMC skills VCA (video Communications assessment) assessment
Time frame: Completed during months 1 and again at around 9-12 months post recruitment.
Residents in both arms will be asked to complete the assessment VCA vignettes that will include a series of vignettes representing challenging cases. Trained raters blinded to the residents' study arm (intervention vs. comparison) will rate the residents' responses.
1 secondary outcome
Change in adoption scale Scores at eighteen months
Time frame: Completed during months 1, 12 and 18 post recruitment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
RAJANI SADASIVAM, PhD principal investigator
UMass Chan Medical School
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Didatic Session 1: Core Foundation Course, The 3Ps Program and Didactic session 2 in people with Weight Management Counseling, 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 4 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RAJANI SADASIVAM, PhD ((508) 856-8989 ext. 68923, Rajani.Sadasivam@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WMC skills assessment (time frame: Completed during month 1 and again at around 9-12 months post recruitment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.