Pediatric Obesity
Conditions
Brief summary
In this cluster randomized effectiveness trial, pediatric primary care practices will be recruited from the American Academy of Pediatrics' national Pediatric Research in Office Settings (PROS) practice-based research network, as well as the client database of the Physician's Computer Company (PCC) - an Electronic Health Record (EHR) vendor. We will recruit 18 practices. 9 practices will be randomized to the Intervention arm and 9 practices to Usual Care. Intervention arm practices will select 1-2 pediatric clinicians, including pediatricians (PED) and nurse practitioners (NP), to receive in-person training in Motivational Interviewing (MI), behavioral therapy, billing and coding, and study procedures. Usual Care practices will select 1-2 pediatric clinicians to receive billing / coding and study protocol training only, via telephone and webinar; they will be offered in-person MI training at the close of the trial. Around 316 parents of overweight or obese children (BMI \> 85th percentile for age and gender) between 3 and 11 years of age at baseline that are patients of participating Intervention arm clinicians will be enrolled. Over 24 months, these parents may receive up to 4 in-person, MI-based counseling sessions with a trained pediatric clinician and up to 6 telephone counseling sessions with an MI-trained Registered Dietician (RD). There will be no study-specific contact with parents or their children in Usual Care practices during the trial - they will continue to receive usual care. EHR and billing data for all 3-11 year old children within all participating practices will be extracted by PCC to permit determination of the effectiveness of the intervention versus usual care on change in BMI z-score among 3 groups: 1) all eligible children in the Intervention arm), 2) all eligible children whose parent actively participates in the trial , and 3) all 3-11 year old children in all participating practices.
Interventions
BEHAVIORALIntervention by Clinicians
•Parents will complete surveys after enrollment and at the end of intervention and participate in intervention visits by pediatric clinicians and telephonic counseling with Registered Dietitians (RDs). Intervention by pediatric clinicians: up to 4 sessions of MI, in-person Intervention by RDs: up to 6 sessions of MI via telephone.
BEHAVIORALUsual Care
Pediatric clinicians provide care as normal
Sponsors
American Academy of Pediatrics
Ann & Robert H Lurie Children's Hospital of Chicago
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After two years of intervention arm study, the usual care arm will receive MI training.
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* For Practices: Currently use Physician's Computer Company (PCC) as their Electronic Health Record (EHR) vendor * For Clinicians: Have been employed by the practice for at least 1 year on or before July 1, 2017 Work \> half time (at least 6 sessions per week) * For Parents: Parent or legal guardian of a child that meets the following criteria: At least 3 but not yet 12 years of age on the date of the baseline data pull (estimated to occur in the summer or fall of 2017). BMI for age and gender \> 85th percentile - documented at an office visit that occurred during the 12 months prior to the baseline data pull. Most recent well-child visit was with a participating study clinician during the 24 months prior to the baseline data pull
Exclusion criteria
* For Practices: Offer a comprehensive weight loss program or access to a RD at or through the practice. Unable or unwilling to send all participating study clinicians to in-person training.Unable or unwilling to identify and assign a study coordinator for the study * For Clinicians: \> 1 day of prior training in MI within the past 10 years. Prior participation in the AAP/PROS Healthy Lifestyles Pilot Study (HLS; AAP IRB protocol # 01SC01) or Brief Motivational Interviewing to Reduce Body Mass Index (BMI2) Study (AAP IRB protocol # 07RE01). * For Parents: Does not speak either English or Spanish. Parent or legal guardian of a child who has any of the following documented in their EHR: Type I or Type II diabetes. Daily or chronic use of medications known to affect growth and mood / behavior (growth hormones, SSRIs, stimulants).Use of atypical antipsychotics. A chronic, limiting, severe medical disorder, syndrome, or other condition (e.g., Downs syndrome, cerebral palsy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Distance From the Sex-age Specific 95th Percentile | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Raw BMI Score | Baseline | Differences between intervention and usual care youth at baseline for raw BMI score |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 329 |
| Total | 329 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 50 | 1 |
Baseline characteristics
| Characteristic | Intervention by Clinicians |
|---|---|
| Age, Categorical <=18 years | 329 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 6.93 years STANDARD_DEVIATION 2.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 110 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 151 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 68 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants |
| Race (NIH/OMB) More than one race | 34 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 67 Participants |
| Race (NIH/OMB) White | 161 Participants |
| Region of Enrollment United States | 280 Participants |
| Sex: Female, Male Female | 146 Participants |
| Sex: Female, Male Male | 134 Participants |
| Sex/Gender, Customized He/Him/His | 131 Participants |
| Sex/Gender, Customized She/Her/Hers | 126 Participants |
| Sex/Gender, Customized They/Them/Their | 5 Participants |
| Two-level Baseline Body Mass Index Categorical Variable High Baseline BMI (Percentile >= 120) | 44 Participants |
| Two-level Baseline Body Mass Index Categorical Variable Low Baseline BMI (Percentile < 120) | 236 Participants |
| Two-level Baseline Body Mass Index Categorical Variable Unknown/Missing | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 11 | 0 / 0 | 0 / 329 |
| other Total, other adverse events | 0 / 11 | 0 / 0 | 1 / 329 |
| serious Total, serious adverse events | 0 / 11 | 0 / 0 | 0 / 329 |
Outcome results
Primary
Percent Distance From the Sex-age Specific 95th Percentile
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention by Clinicians | Percent Distance From the Sex-age Specific 95th Percentile | 106.4 % distance from 95th percentile | Standard Deviation 15.88 |
| Usual Care | Percent Distance From the Sex-age Specific 95th Percentile | 102.7 % distance from 95th percentile | Standard Deviation 13.32 |
Secondary
Raw BMI Score
Differences between intervention and usual care youth at baseline for raw BMI score
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention by Clinicians | Raw BMI Score | 21.4 kg/m^2 | Standard Deviation 4.39 |
| Usual Care | Raw BMI Score | 20.5 kg/m^2 | Standard Deviation 3.51 |