NCT02946515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

July 27, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 26, 2019

Completed
Last Updated

August 23, 2023

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

October 25, 2016

Results QC Date

October 1, 2018

Last Update Submit

August 21, 2023

Conditions

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months after baseline

Study Arms (2)

Educational Intervention

EXPERIMENTAL

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.

Behavioral: Educational Intervention

Waitlist Control Group

EXPERIMENTAL

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.

Behavioral: Wait List Control

Interventions

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.

Educational Intervention

Access to the online simulation training after the follow-up measurement visit is complete

Waitlist Control Group

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Institute

Bloomington, Minnesota, 55330, United States

Location

Related Publications (4)

  • 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.

    PMID: 19587253BACKGROUND
  • 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.

    PMID: 18954581BACKGROUND
  • 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.

    PMID: 12093997BACKGROUND
  • 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.

    PMID: 17126634BACKGROUND

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Results Point of Contact

Title
Dr. Nancy E. Sherwood, Associate Professor
Organization
University of Minnesota - Division of Epidemiology and Community Health

Study Officials

  • Nancy E Sherwood, Ph.D

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 27, 2016

Study Start

July 27, 2017

Primary Completion

October 25, 2017

Study Completion

October 25, 2017

Last Updated

August 23, 2023

Results First Posted

August 26, 2019

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations