NCT02946515: SIM-PLICITY

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

Completed NA Results posted Last updated 23 August 2023

What this trial tests

NA trial testing Educational Intervention in Childhood Obesity in 44 participants. Completed in 25 October 2017.

Timeline

27 July 2017

Primary endpoint
25 October 2017

25 October 2017

Quick facts

Lead sponsor	HealthPartners Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	44
Start date	27 July 2017
Primary completion	25 October 2017
Estimated completion	25 October 2017
Sites	1 location across United States

Drugs / interventions tested

• Educational Intervention
• Wait List Control

Conditions studied

• Childhood Obesity — all drugs for Childhood Obesity →

Sponsor

HealthPartners Institute

Who can join

Adults 21 to 75, any sex, with Childhood Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Simulation Total Role Play Score Primary · 3 months after baseline

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

Baseline Mean

Group	Value	95% CI
Educational Intervention	25.73	± 6.27
Waitlist Control Group	23.73	± 6.71

Follow-up Mean

Group	Value	95% CI
Educational Intervention	33.29	± 4.75
Waitlist Control Group	25.89	± 4.67

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.