Trial Outcomes & Findings for Population Effects of MI on Pediatric Obesity in Primary Care (NCT NCT03177148)
NCT ID: NCT03177148
Last Updated: 2024-07-16
Results Overview
Differences between intervention and usual care youth at baseline for distance from the 95th percentile for BMI. BMI data from children seen by Usual Care arm pediatric clinicians were matched (3 to 1) to intervention arm children.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
352 participants
Primary outcome timeframe
Baseline
Results posted on
2024-07-16
Participant Flow
Practices and pediatric clinicians were recruited through the AAP Pediatric Research in Office Settings (PROS) network who used Physician's Computer Company (PCC), an EHR vendor tailored to pediatric practices. Pediatric clinicians were enrolled in intervention arm and usual care arm and completed baseline and follow-up surveys. Parents/caregivers were only enrolled in the intervention arm and completed baseline and follow-up surveys. Parents chose one of their eligible children to enroll.
18 pediatric practices were randomized to the intervention or usual control arm. Parents/caregivers were only enrolled in the intervention arm provided self-report survey data. Children were enrolled by their Parent/Caregiver in the intervention arm ONLY. Childrens data was extracted from the EHR for BOTH the intervention and usual care arm. NO children were enrolled in the usual care arm, only child BMI data from enrolled pediatric clinicians in the usual care arm were used.
Unit of analysis: Pediatric practices
Participant milestones
| Measure |
Intervention by Clinicians
* Pediatric Clinicians complete surveys during enrollment and end of the intervention
* 1-2 clinicians from each practice will receive 2.5 days of in-person MI training, two scored encounters with a standardized patient, and an interactive DVD MI booster training system focusing on pediatric obesity.
* Enroll 35 eligible parents per practice
* Clinicians give up to 4 in-person, MI sessions to enrolled parents over 2 years.
* Dietitians will provide up to 6 telephone counseling sessions.
* Parents will complete surveys after enrollment and at the end of intervention
|
Usual Care
* 1-2 pediatric clinicians per practice will be trained in study procedures, current obesity treatment guidelines, and obesity billing and coding via telephone and webinar.
* NO active enrollment of parents
* Secure extraction of HIPAA limited Electronic Health Record (EHR) and billing data from practices for outcomes analyses.
* At the end of the intervention period, 1-2 pediatric clinicians will be offered the in-person MI training and DVD materials.
|
|---|---|---|
|
Overall Study
STARTED
|
340 9
|
12 9
|
|
Overall Study
COMPLETED
|
289 8
|
11 8
|
|
Overall Study
NOT COMPLETED
|
51 1
|
1 1
|
Reasons for withdrawal
| Measure |
Intervention by Clinicians
* Pediatric Clinicians complete surveys during enrollment and end of the intervention
* 1-2 clinicians from each practice will receive 2.5 days of in-person MI training, two scored encounters with a standardized patient, and an interactive DVD MI booster training system focusing on pediatric obesity.
* Enroll 35 eligible parents per practice
* Clinicians give up to 4 in-person, MI sessions to enrolled parents over 2 years.
* Dietitians will provide up to 6 telephone counseling sessions.
* Parents will complete surveys after enrollment and at the end of intervention
|
Usual Care
* 1-2 pediatric clinicians per practice will be trained in study procedures, current obesity treatment guidelines, and obesity billing and coding via telephone and webinar.
* NO active enrollment of parents
* Secure extraction of HIPAA limited Electronic Health Record (EHR) and billing data from practices for outcomes analyses.
* At the end of the intervention period, 1-2 pediatric clinicians will be offered the in-person MI training and DVD materials.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
50
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
49 participants could not be contacted for follow-up data
Baseline characteristics by cohort
| Measure |
Intervention by Clinicians
n=329 Participants
* Pediatric Clinicians complete surveys during enrollment and end of the intervention
* 1-2 clinicians from each practice will receive 2.5 days of in-person MI training, two scored encounters with a standardized patient, and an interactive DVD MI booster training system focusing on pediatric obesity.
* Enroll 35 eligible parents per practice
* Clinicians give up to 4 in-person, MI sessions to enrolled parents over 2 years.
* Dietitians will provide up to 6 telephone counseling sessions.
* Parents will complete surveys after enrollment and at the end of intervention
|
|---|---|
|
Age, Categorical
<=18 years
|
329 Participants
n=329 Participants • 49 participants could not be contacted for follow-up data
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=329 Participants • 49 participants could not be contacted for follow-up data
|
|
Age, Categorical
>=65 years
|
0 Participants
n=329 Participants • 49 participants could not be contacted for follow-up data
|
|
Age, Continuous
|
6.93 years
STANDARD_DEVIATION 2.54 • n=329 Participants
|
|
Sex/Gender, Customized
He/Him/His
|
131 Participants
n=262 Participants • Collected by survey completed by parent. 67 parents did not complete this baseline survey question leaving 262 as the overall number of baseline participants for this baseline characteristic.
|
|
Sex/Gender, Customized
She/Her/Hers
|
126 Participants
n=262 Participants • Collected by survey completed by parent. 67 parents did not complete this baseline survey question leaving 262 as the overall number of baseline participants for this baseline characteristic.
|
|
Sex/Gender, Customized
They/Them/Their
|
5 Participants
n=262 Participants • Collected by survey completed by parent. 67 parents did not complete this baseline survey question leaving 262 as the overall number of baseline participants for this baseline characteristic.
|
|
Sex: Female, Male
Female
|
146 Participants
n=280 Participants • 49 parents did not provide a response to this survey question.
|
|
Sex: Female, Male
Male
|
134 Participants
n=280 Participants • 49 parents did not provide a response to this survey question.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
110 Participants
n=329 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
151 Participants
n=329 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
68 Participants
n=329 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=329 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=329 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=329 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=329 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=329 Participants
|
|
Race (NIH/OMB)
More than one race
|
34 Participants
n=329 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
67 Participants
n=329 Participants
|
|
Region of Enrollment
United States
|
280 Participants
n=280 Participants • 49 parents did not provide a response to this survey question leaving 280 as the overall number of participants analyzed for this for baseline characteristic.
|
|
Two-level Baseline Body Mass Index Categorical Variable
Low Baseline BMI (Percentile < 120)
|
236 Participants
n=329 Participants
|
|
Two-level Baseline Body Mass Index Categorical Variable
High Baseline BMI (Percentile >= 120)
|
44 Participants
n=329 Participants
|
|
Two-level Baseline Body Mass Index Categorical Variable
Unknown/Missing
|
49 Participants
n=329 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Treatment by time interaction predicted distance above the 95th percentile. The Overall Number of Participants Analyzed reflects data extracted from EHR of children who were seen by the enrolled physicians. The overall number of participants analyzed in the usual care arm represents the BMI data extracted from children seen by the enrolled usual care arm clinicians. These children were not considered enrolled.
Differences between intervention and usual care youth at baseline for distance from the 95th percentile for BMI. BMI data from children seen by Usual Care arm pediatric clinicians were matched (3 to 1) to intervention arm children.
Outcome measures
| Measure |
Intervention by Clinicians
n=280 Participants
* Pediatric Clinicians complete surveys during enrollment and end of the intervention
* 1-2 clinicians from each practice will receive 2.5 days of in-person MI training, two scored encounters with a standardized patient, and an interactive DVD MI booster training system focusing on pediatric obesity.
* Enroll 35 eligible parents per practice
* Clinicians give up to 4 in-person, MI sessions to enrolled parents over 2 years.
* Dietitians will provide up to 6 telephone counseling sessions.
* Parents will complete surveys after enrollment and at the end of intervention
|
Usual Care
n=840 Participants
* 1-2 pediatric clinicians per practice will be trained in study procedures, current obesity treatment guidelines, and obesity billing and coding via telephone and webinar.
* NO active enrollment of parents and children
* Secure extraction of HIPAA limited Electronic Health Record (EHR) and billing data from practices for outcomes analyses.
* At the end of the intervention period, 1-2 pediatric clinicians will be offered the in-person MI training and DVD materials.
* BMI data from children seen by Usual Care arm pediatric clinicians were reviewed and the BMI data in the EHR at baseline and follow up were matched with the intervention arm children after the study.
|
|---|---|---|
|
Percent Distance From the Sex-age Specific 95th Percentile
|
106.4 % distance from 95th percentile
Standard Deviation 15.88
|
102.7 % distance from 95th percentile
Standard Deviation 13.32
|
SECONDARY outcome
Timeframe: BaselinePopulation: 3:1 matched cohort. The Overall Number of Participants Analyzed reflects data extracted from EHR of children who were seen by the enrolled physicians. The overall number of participants analyzed in the usual care arm represents the BMI data extracted from children seen by the enrolled usual care arm clinicians. These children were not considered enrolled.
Differences between intervention and usual care youth at baseline for raw BMI score
Outcome measures
| Measure |
Intervention by Clinicians
n=280 Participants
* Pediatric Clinicians complete surveys during enrollment and end of the intervention
* 1-2 clinicians from each practice will receive 2.5 days of in-person MI training, two scored encounters with a standardized patient, and an interactive DVD MI booster training system focusing on pediatric obesity.
* Enroll 35 eligible parents per practice
* Clinicians give up to 4 in-person, MI sessions to enrolled parents over 2 years.
* Dietitians will provide up to 6 telephone counseling sessions.
* Parents will complete surveys after enrollment and at the end of intervention
|
Usual Care
n=840 Participants
* 1-2 pediatric clinicians per practice will be trained in study procedures, current obesity treatment guidelines, and obesity billing and coding via telephone and webinar.
* NO active enrollment of parents and children
* Secure extraction of HIPAA limited Electronic Health Record (EHR) and billing data from practices for outcomes analyses.
* At the end of the intervention period, 1-2 pediatric clinicians will be offered the in-person MI training and DVD materials.
* BMI data from children seen by Usual Care arm pediatric clinicians were reviewed and the BMI data in the EHR at baseline and follow up were matched with the intervention arm children after the study.
|
|---|---|---|
|
Raw BMI Score
|
21.4 kg/m^2
Standard Deviation 4.39
|
20.5 kg/m^2
Standard Deviation 3.51
|
Adverse Events
Intervention Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Intervention Parents/Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Children
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Clinicians
n=11 participants at risk
* Pediatric Clinicians complete surveys during enrollment and end of the intervention
* 1-2 clinicians from each practice will receive 2.5 days of in-person MI training, two scored encounters with a standardized patient, and an interactive DVD MI booster training system focusing on pediatric obesity.
* Enroll 35 eligible parents per practice
* Clinicians give up to 4 in-person, MI sessions to enrolled parents over 2 years.
* Dietitians will provide up to 6 telephone counseling sessions.
* Parents will complete surveys after enrollment and at the end of intervention
|
Intervention Parents/Caregivers
* Pediatric Clinicians complete surveys during enrollment and end of the intervention
* 1-2 clinicians from each practice will receive 2.5 days of in-person MI training, two scored encounters with a standardized patient, and an interactive DVD MI booster training system focusing on pediatric obesity.
* Enroll 35 eligible parents per practice
* Clinicians give up to 4 in-person, MI sessions to enrolled parents over 2 years.
* Dietitians will provide up to 6 telephone counseling sessions.
* Parents will complete surveys after enrollment and at the end of intervention
|
Intervention Children
n=329 participants at risk
* Pediatric Clinicians complete surveys during enrollment and end of the intervention
* 1-2 clinicians from each practice will receive 2.5 days of in-person MI training, two scored encounters with a standardized patient, and an interactive DVD MI booster training system focusing on pediatric obesity.
* Enroll 35 eligible parents per practice
* Clinicians give up to 4 in-person, MI sessions to enrolled parents over 2 years.
* Dietitians will provide up to 6 telephone counseling sessions.
* Parents will complete surveys after enrollment and at the end of intervention
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Other Adverse Event
|
0.00%
0/11 • 4-years
Only the intervention arm was assessed for adverse events. Adverse events were not monitored/assessed in the parent/caregiver populations; only children were monitored/assessed for adverse events
|
—
0/0 • 4-years
Only the intervention arm was assessed for adverse events. Adverse events were not monitored/assessed in the parent/caregiver populations; only children were monitored/assessed for adverse events
|
0.30%
1/329 • Number of events 1 • 4-years
Only the intervention arm was assessed for adverse events. Adverse events were not monitored/assessed in the parent/caregiver populations; only children were monitored/assessed for adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place