Childhood Obesity
Conditions
Keywords
Pediatrics
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.
Interventions
BEHAVIORALEducational Intervention
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.
BEHAVIORALWait List Control
Access to the online simulation training after the follow-up measurement visit is complete
Sponsors
SIMmersion, LLC
University of Minnesota
Northwestern University
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Simulation Total Role Play Score | 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 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. |
Countries
United States
Participant flow
Recruitment details
Medical and nursing students were recruited from a local university, and pediatric primary care practitioners were recruited through a local health system. All participants were recruited by email and invited to participate. Interested participants were contacted by study team members about the study and an in-person baseline visit was scheduled.
Pre-assignment details
At baseline, participants reviewed and signed the consent form in-person and were given a hard copy for their records. After the baseline measurement visit, participants were randomized to either the intervention group or the wait-list control group. Due to the visit occurring in person, all participants who were consented were randomized (N=44).
Participants by arm
| Arm | Count |
|---|---|
| Educational Intervention The educational intervention was an online simulation training program. Participants were taught how to use the simulation during a brief phone orientation session with a research staff person. A mastery based approach was used, rather than prescribing an absolute number of hours participants need to play. The criteria were 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 were completed by participants on their own. The research team confirmed remote usage and contacted participants by email and phone to prompt usage as needed.
The intervention group participated in pre- and post-test assessments of their conversational skills with a trained actor. | 22 |
| Waitlist Control Group The control group participated in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the wait-list control group were allowed to access to the simulation. Access was provided by the study team to all participants in the control group after completion of their post-test assessment. | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Educational Intervention | Waitlist Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 22 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Female | 14 Participants | 19 Participants | 33 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
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.
Time frame: 3 months after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Educational Intervention | Simulation Total Role Play Score | Baseline Mean | 25.73 score on a scale | Standard Deviation 6.27 |
| Educational Intervention | Simulation Total Role Play Score | Follow-up Mean | 33.29 score on a scale | Standard Deviation 4.75 |
| Waitlist Control Group | Simulation Total Role Play Score | Baseline Mean | 23.73 score on a scale | Standard Deviation 6.71 |
| Waitlist Control Group | Simulation Total Role Play Score | Follow-up Mean | 25.89 score on a scale | Standard Deviation 4.67 |