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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL128231-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| American Academy of Pediatrics | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator |
At the end of the intervention period, 1-2 pediatric clinicians will be offered the in-person MI training and DVD materials |
|
| Intervention by Clinicians | Experimental |
Dietitians will provide up to 6 telephone counseling sessions. •Parents will complete surveys after enrollment and at the end of intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention by Clinicians | Behavioral | •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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Raw BMI Score | Differences between intervention and usual care youth at baseline for raw BMI score | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Resnicow, Ph.D. | University of Michigan | Principal Investigator |
| Emerson Delacroix, M.A.C.P. | University of Michigan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Research in Office Settings | Itasca | Illinois | 60143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32723736 | Derived | Wright ME, Delacroix E, Sonneville KR, Considine S, Proctor T, Steffes J, Harris D, Shone LP, Woo H, Vaughan R, Grundmeier RW, Fiks AG, Stockwell MS, Resnicow K. Reducing paediatric overweight and obesity through motivational interviewing: study protocol for a randomised controlled trial in the AAP PROS research network. BMJ Open. 2020 Jul 28;10(7):e035720. doi: 10.1136/bmjopen-2019-035720. |
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An external DSMB will be used. They will meet at least once a year, and will convene as needed to review potential adverse events.
The study teams at University of Michigan and the American Academy of Pediatrics disseminate the protocol with any deviations or adverse events to the external DSMB for their annual meeting, and at the conclusion of the study. Data will be de-identified after the intervention phase ends which is planned for May 2021.
DSMB members and study team members have access to the data and results of the study.
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention by Clinicians |
|
| FG001 | Usual Care |
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Parents/caregivers enrolled one child into the intervention. Parents/caregivers completed a baseline survey about the enrolled child. BMI values were extracted from the EHR. Parents/caregivers and intervention pediatric clinicians did not report baseline survey responses for baseline analysis population description. No baseline characteristic data was collected for the Usual Care Arm (clinicians, parents or children).
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention by Clinicians |
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Collected from electronic health record |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | % distance from 95th percentile | Baseline |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Clinicians |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Adverse Event | Metabolism and nutrition disorders | Other Adverse Event | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mx. Emerson Delacroix | University of Michigan | 734-764-2014 | emmed@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jul 1, 2017 | Jul 22, 2022 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2021 | Jan 30, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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After two years of intervention arm study, the usual care arm will receive MI training.
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| Usual Care | Behavioral | Pediatric clinicians provide care as normal |
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49 participants could not be contacted for follow-up data
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | 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. | Count of Participants | Participants |
|
| Sex: Female, Male | Collected by survey completed by parent. | 49 parents did not provide a response to this survey question. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | 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. | Count of Participants | Participants |
|
| Two-level Baseline Body Mass Index Categorical Variable | Count of Participants | Participants |
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| OG001 | Usual Care |
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|
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| Secondary | Raw BMI Score | Differences between intervention and usual care youth at baseline for raw BMI score | 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. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline |
|
|
|
| 1 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Intervention Parents/Caregivers |
| 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Intervention Children |
| 0 | 329 | 0 | 329 | 1 | 329 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |