search
Back to results

The SIM-PLICITY Study: The SIMulation Project - LIstening & Intervention in Pediatric obeSITY (SIM-PLICITY)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Wait List Control
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Pediatrics

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 21 years of age or older
  • A health care provider within the HealthPartners Medical Group system or Park Nicollet clinic system OR a resident in the University of Minnesota pediatrics and family medicine residency program OR a student in the University of Minnesota nursing program or medical school
  • Willing and able to participate in measurement visits and intervention activities
  • See pediatric patients greater than or equal to 1/3 of their practice time

Exclusion Criteria:

  • < 21 years of age
  • Unable to ensure commitment to study measurement and intervention activities
  • See pediatric patients less than 1/3 of their practice time

Sites / Locations

  • HealthPartners Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Educational Intervention

Waitlist Control Group

Arm Description

The educational intervention will be the online simulation training program. Participants will be taught how to use the simulation during a 30 minute orientation session with a research staff person. We will use a mastery based approach rather than prescribing an absolute number of hours participants need to play. The criteria are as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions will be completed by participants on their own. The research team will confirm remote usage, and contact participants by email and phone to prompt usage as needed. The research team anticipates that the proposed method will accommodate for participant schedules while still ensuring intervention compliance.

The control group will participate in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the waitlist control group will be allowed to access to the simulation and the study team will provide training to participants upon request.

Outcomes

Primary Outcome Measures

Simulation Total Role Play Score
Change from baseline in simulation total role-play score with a trained actor to evaluate the simulation's efficacy. The role-play scale measured the clinical skills of the participants assessed using standardized patients (SPs), blind to study condition, who acted as parents of a child with overweight during a well-child visit. Immediately following each 15-minute interaction with a study participant, the SP completed a checklist that assessed whether the participant 1) completed the skill correctly, 2) completed the skill incorrectly; or 3) did not complete the skill. Participants received a score of 1 if they completed the skill correctly in both Case A and Case B. The minimum score on the scale is 0 and the maximum score is 60, with higher scores indicating a better outcome.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2016
Last Updated
August 21, 2023
Sponsor
HealthPartners Institute
Collaborators
SIMmersion, LLC, University of Minnesota, Northwestern University
search

1. Study Identification

Unique Protocol Identification Number
NCT02946515
Brief Title
The SIM-PLICITY Study: The SIMulation Project - LIstening & Intervention in Pediatric obeSITY
Acronym
SIM-PLICITY
Official Title
Virtual Role-Plays to Reduce the Occurrence of Childhood Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 27, 2017 (Actual)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
SIMmersion, LLC, University of Minnesota, Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is looking at the feasibility and efficacy of using SIMmersion's PeopleSim technology to train providers through role playing simulations to effectively conduct discussions with parents to provide intervention for, and reduce the likelihood of progression to childhood obesity.
Detailed Description
The prevalence of childhood obesity has tripled within the last twenty-five years (Skelton et al., 2009). Interventions targeting children are a high priority because children bear the greatest lifetime health risk from overweight and obesity (Ogden et al., 2007; Franks et al., 2010). Health professionals in primary care settings have the potential to reach large numbers of parents and children and address obesity because they have regular interactions with and are influential in the lives of families. Studies show that even brief advice delivered well can have a meaningful impact. To support providers in this important role, the Centers for Disease Control and Prevention collaborated with other health organizations to develop recommendations for assessment, prevention, and treatment of childhood and adolescent overweight and obesity. Despite the 2007 publication of these recommendations and increasing recognition of childhood obesity as a public health problem, rates of provision of obesity-related guidance and counseling remain low (Tanda & Salsberry, 2013), and research indicates that health care providers could use additional education, training, and support related to obesity prevention and treatment. Thus, effective strategies to support pediatric primary care providers in their efforts to intervene against address childhood obesity are needed. Building off the successes achieved in their Phase I study, SIMmersion LLC, in collaboration with Dr. Nancy Sherwood from HealthPartners Institute , Dr. Jayne Fulkerson from the University of Minnesota, and Dr. Michael Fleming from Northwestern University, will expand the Phase I simulation prototype, utilizing feedback provided by a team of independent experts. The innovative computer-based training system with interactive role-play simulations will provide health care providers with much needed experiential opportunities to develop skills in conducting discussions with parents and children about obesity. The product's efficacy will be evaluated in a randomized controlled trial (RCT); 100 pediatric, family practice, and nursing clinicians and trainees at various levels of experience will be recruited to participate. Half of the participants will be randomly assigned to the intervention group during which they will use the newly developed simulation product to develop their skills and half of participants will be randomly assigned to the wait-list control group; the primary outcome is performance in a role play with trained actors at 2 month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Pediatrics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational Intervention
Arm Type
Experimental
Arm Description
The educational intervention will be the online simulation training program. Participants will be taught how to use the simulation during a 30 minute orientation session with a research staff person. We will use a mastery based approach rather than prescribing an absolute number of hours participants need to play. The criteria are as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions will be completed by participants on their own. The research team will confirm remote usage, and contact participants by email and phone to prompt usage as needed. The research team anticipates that the proposed method will accommodate for participant schedules while still ensuring intervention compliance.
Arm Title
Waitlist Control Group
Arm Type
Experimental
Arm Description
The control group will participate in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the waitlist control group will be allowed to access to the simulation and the study team will provide training to participants upon request.
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention
Intervention Description
The educational intervention will be the online simulation training program. Participants will be taught how to use the simulation during a 30 minute orientation session with a research staff person. We will use a mastery based approach rather than prescribing an absolute number of hours participants need to play. The criteria are as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions will be completed by participants on their own. The research team will confirm remote usage, and contact participants by email and phone to prompt usage as needed. The research team anticipates that the proposed method will accommodate for participant schedules while still ensuring intervention compliance.
Intervention Type
Behavioral
Intervention Name(s)
Wait List Control
Intervention Description
Access to the online simulation training after the follow-up measurement visit is complete
Primary Outcome Measure Information:
Title
Simulation Total Role Play Score
Description
Change from baseline in simulation total role-play score with a trained actor to evaluate the simulation's efficacy. The role-play scale measured the clinical skills of the participants assessed using standardized patients (SPs), blind to study condition, who acted as parents of a child with overweight during a well-child visit. Immediately following each 15-minute interaction with a study participant, the SP completed a checklist that assessed whether the participant 1) completed the skill correctly, 2) completed the skill incorrectly; or 3) did not complete the skill. Participants received a score of 1 if they completed the skill correctly in both Case A and Case B. The minimum score on the scale is 0 and the maximum score is 60, with higher scores indicating a better outcome.
Time Frame
3 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21 years of age or older A health care provider within the HealthPartners Medical Group system or Park Nicollet clinic system OR a resident in the University of Minnesota pediatrics and family medicine residency program OR a student in the University of Minnesota nursing program or medical school Willing and able to participate in measurement visits and intervention activities See pediatric patients greater than or equal to 1/3 of their practice time Exclusion Criteria: < 21 years of age Unable to ensure commitment to study measurement and intervention activities See pediatric patients less than 1/3 of their practice time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy E Sherwood, Ph.D
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55330
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19587253
Citation
Fleming M, Olsen D, Stathes H, Boteler L, Grossberg P, Pfeifer J, Schiro S, Banning J, Skochelak S. Virtual reality skills training for health care professionals in alcohol screening and brief intervention. J Am Board Fam Med. 2009 Jul-Aug;22(4):387-98. doi: 10.3122/jabfm.2009.04.080208.
Results Reference
background
PubMed Identifier
18954581
Citation
Kubik MY, Story M, Davey C, Dudovitz B, Zuehlke EU. Providing obesity prevention counseling to children during a primary care clinic visit: results from a pilot study. J Am Diet Assoc. 2008 Nov;108(11):1902-6. doi: 10.1016/j.jada.2008.08.017.
Results Reference
background
PubMed Identifier
12093997
Citation
Story MT, Neumark-Stzainer DR, Sherwood NE, Holt K, Sofka D, Trowbridge FL, Barlow SE. Management of child and adolescent obesity: attitudes, barriers, skills, and training needs among health care professionals. Pediatrics. 2002 Jul;110(1 Pt 2):210-4.
Results Reference
background
PubMed Identifier
17126634
Citation
Resnicow K, Davis R, Rollnick S. Motivational interviewing for pediatric obesity: Conceptual issues and evidence review. J Am Diet Assoc. 2006 Dec;106(12):2024-33. doi: 10.1016/j.jada.2006.09.015.
Results Reference
background
Links:
URL
http://www.healthpartners.com/institute/index.html
Description
Institutional Organization Website

Learn more about this trial

The SIM-PLICITY Study: The SIMulation Project - LIstening & Intervention in Pediatric obeSITY

We'll reach out to this number within 24 hrs