Pediatric ObesityBMi2+NCT03177148
Population Effects of MI on Pediatric Obesity in Primary Care
A study testing Intervention by Clinicians in people with Pediatric Obesity, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Intervention by Clinicians
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Research in Office Settings
Itasca, Illinois, 60143
About this study
Official title: Population Effects of Motivational Interviewing on Pediatric Obesity in Primary Care
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.
- Conditions
- Pediatric Obesity
- Being tested
- Intervention by Clinicians, Usual Care
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention by CliniciansBehavioural
Also called MI Intervention
•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.
Usual CareBehavioural
Pediatric clinicians provide care as normal
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | * 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 Receives: Behavioral: Usual Care |
| Intervention by Clinicians | Experimental | * 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 Receives: Behavioral: Intervention by Clinicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Raw BMI Score
Differences between intervention and usual care youth at baseline for raw BMI score
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Jul 2017
- Primary completion31 Jan 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After two years of intervention arm study, the usual care arm will receive MI training.
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, Ann & Robert H Lurie Children's Hospital of Chicago, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ken Resnicow, University of Michigan
- Investigators
- Kenneth Resnicow, Ph.D., Principal investigator, University of MichiganEmerson Delacroix, M.A.C.P., Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177148
- Sponsor's protocol ID
- BMi2+
- Other IDs
- 5R01HL128231-05
- Acronym
- BMi2+
- Status last verified
- Jun 2024
- First submitted
- 31 May 2017
- Last updated
- 16 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An external DSMB will be used. They will meet at least once a year, and will convene as needed to review potential adverse events.
Publications
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.
PubMed 32723736
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Effects of Motivational Interviewing on Pediatric Obesity in Primary Care
- ClinicalTrials.gov ID
- NCT03177148
- Acronym / sponsor ID
- BMi2+ / BMi2+
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, Ann & Robert H Lurie Children's Hospital of Chicago, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After two years of intervention arm study, the usual care arm will receive MI training.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: 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 |
| Intervention by Clinicians | Experimental | Behavioral: 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 |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention by CliniciansAlso: MI Intervention•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. | Behavioural | Intervention by Clinicians |
| Usual CarePediatric clinicians provide care as normal | Behavioural | Usual Care |
Primary outcome
Percent Distance From the Sex-age Specific 95th Percentile
Time frame: 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.
1 secondary outcome
Raw BMI Score
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32723736Wright 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.
- Individual participant dataSharing planned: Yes. An external DSMB will be used. They will meet at least once a year, and will convene as needed to review potential adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Resnicow, Ph.D. principal investigator
University of Michigan
Emerson Delacroix, M.A.C.P. study director
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention by Clinicians in people with Pediatric Obesity, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Distance From the Sex-age Specific 95th Percentile (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03177148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.