ObesityNCT02850224
Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes
A study testing Motivational interviewing to elicit PCO in pediatrics in people with Obesity and Overweight, run by Henry Ford Health System at 1 site in United States.
Trial summary
In 2012, an Expert Panel of the National Heart Lung and Blood Institute published guidelines on cardiovascular health and risk reduction in children; among these guidelines were screening recommendations for obesity and obesity-related conditions. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Blood Pressure
- What is being tested?
- Motivational interviewing to elicit PCO in pediatrics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 703 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to 27 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between the ages of 2 and 18
- Henry Ford Health System Patient
- Well-child visit with participating provider
- Fluent in English
Who cannot join
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Preventative Health Screenings - Obesity and Family-Centered
In 2012, an Expert Panel of the National Heart Lung and Blood Institute published guidelines on cardiovascular health and risk reduction in children; among these guidelines were screening recommendations for obesity and obesity-related conditions. Following publication of this report there was a call for caution and for increased patient (parent, child) input on implementing these guidelines. There are limited current studies evaluating patient-centered outcomes (PCO) in the well-child setting, however, given the childhood obesity epidemic, there is a clear need for such an evaluation. The city of Detroit, MI ranks first among 22 cities with data for the prevalence of overweight and obese youth (39.7%), making Henry Ford Health System, which is located in Detroit, MI, an ideal setting to study childhood obesity related research questions.
Read the detailed description
Within this patient population, our specific aims therefore are to (1) examine current trends in screening and management of obesity and obesity-related conditions in a real-world urban practice setting; (2) examine the family (patient and parent/guardian) and clinician preferences for the identification and management of obesity and obesity-related conditions; and (3) design and conduct a Phase II pragmatic cluster randomized trial (PCRT) of an educational intervention in providers for guiding screening for obesity and obesity-related conditions during the well-child visit that incorporates and leverages PCO. Staff dedicated solely to this project will partner with the Henry Ford Health System's proposed Patient-Centered Outcomes Research Center's Cores staff members to design, execute and disseminate study results in order to affect clinical care. By seeking to understand the current screening patterns in pediatrics and by creating an education intervention for providers aimed at taking a patient/family centered approach to these preventative health screenings, we may increase PCOs which in turn may have meaningful implications for future adult health.
- Conditions
- Obesity, Overweight, Blood Pressure, Hypercholesteremia, Diabetes
- Being tested
- Motivational interviewing to elicit PCO in pediatrics
- Medical subject headings
- Obesity, Overweight, Hypercholesterolemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing to elicit PCO in pediatricsBehavioural
Also called Motivational Interviewing, Patient-Centered Outcomes
A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing to elicit PCO in pediatrics | Experimental | Providers will be randomized into a patient-centered outcomes (PCO) education course or standard of care. The PCO education course will educate and test providers on patient-centered outcomes of interest and appropriate methods to deliver PCO care.
Providers randomized into the intervention arm will be required to take a brief, one-hour, webinar describing the background, problem, results from focus groups we conducted, and a training program on motivational interviewing. After completing the course, providers will be required to complete an evaluation. Receives: Behavioral: Motivational interviewing to elicit PCO in pediatrics |
| No Intervention | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with improved patient-centered outcomes (physical, social, and emotional health) as assessed by the PROMIS 25.
Measured: 6 weeks
Number of participants with improved health-related quality of life as assessed by the PEDsQL.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start20 Apr 2017
- Primary completion19 Feb 2018
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Cassidy-Bushrow, PhD, Henry Ford Health System
- Investigators
- Andrea E Cassidy-Bushrow, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850224
- Sponsor's protocol ID
- B21201
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2016
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Preventative Health Screenings - Obesity and Family-Centered
- ClinicalTrials.gov ID
- NCT02850224
- Acronym / sponsor ID
- B21201
- Conditions
- Obesity, Overweight, Blood Pressure, Hypercholesteremia, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2012, an Expert Panel of the National Heart Lung and Blood Institute published guidelines on cardiovascular health and risk reduction in children; among these guidelines were screening recommendations for obesity and obesity-related conditions. Following publication of this report there was a call for caution and for increased patient (parent, child) input on implementing these guidelines. There are limited current studies evaluating patient-centered outcomes (PCO) in the well-child setting, however, given the childhood obesity epidemic, there is a clear need for such an evaluation. The city of Detroit, MI ranks first among 22 cities with data for the prevalence of overweight and obese youth (39.7%), making Henry Ford Health System, which is located in Detroit, MI, an ideal setting to study childhood obesity related research questions.
Detailed description
Within this patient population, our specific aims therefore are to (1) examine current trends in screening and management of obesity and obesity-related conditions in a real-world urban practice setting; (2) examine the family (patient and parent/guardian) and clinician preferences for the identification and management of obesity and obesity-related conditions; and (3) design and conduct a Phase II pragmatic cluster randomized trial (PCRT) of an educational intervention in providers for guiding screening for obesity and obesity-related conditions during the well-child visit that incorporates and leverages PCO. Staff dedicated solely to this project will partner with the Henry Ford Health System's proposed Patient-Centered Outcomes Research Center's Cores staff members to design, execute and disseminate study results in order to affect clinical care. By seeking to understand the current screening patterns in pediatrics and by creating an education intervention for providers aimed at taking a patient/family centered approach to these preventative health screenings, we may increase PCOs which in turn may have meaningful implications for future adult health.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing to elicit PCO in pediatrics | Experimental | Behavioral: Motivational interviewing to elicit PCO in pediatricsProviders will be randomized into a patient-centered outcomes (PCO) education course or standard of care. The PCO education course will educate and test providers on patient-centered outcomes of interest and appropriate methods to deliver PCO care. Providers randomized into the intervention arm will be required to take a brief, one-hour, webinar describing the background, problem, results from focus groups we conducted, and a training program on motivational interviewing. After completing the course, providers will be required to complete an evaluation. |
| No Intervention | No intervention | –Standard care |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between the ages of 2 and 18
- Henry Ford Health System Patient
- Well-child visit with participating provider
- Fluent in English
Key exclusion criteria (1 listed)
- Unable to provide consent
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 |
|---|---|---|
| Motivational interviewing to elicit PCO in pediatricsAlso: Motivational Interviewing, Patient-Centered OutcomesA motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques. | Behavioural | Motivational interviewing to elicit PCO in pediatrics |
Primary outcome
Number of participants with improved patient-centered outcomes (physical, social, and emotional health) as assessed by the PROMIS 25.
Time frame: 6 weeks
Number of participants with improved health-related quality of life as assessed by the PEDsQL.
Time frame: 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Andrea E Cassidy-Bushrow, PhD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing to elicit PCO in pediatrics in people with Obesity and Overweight, run by Henry Ford Health System 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 4 inclusion and 1 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 28 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with improved patient-centered outcomes (physical, social, and emotional health) as assessed by the PROMIS 25. (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020.