Self-regulationPCONNCT02206191
The Primary Care Obesity Network (PCON): Incorporating Principles of Self-regulation of Intake
An observational study of Self-regulation, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
In response to the high prevalence rates of childhood obesity in central Ohio, the Center for Healthy Weight and Nutrition (CHWN) established the Primary Care Obesity Network (PCON); a partnership between primary care physicians and Nationwide Children's Hospital's Center for Healthy Weight and Nutrition, a tertiary… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Self-regulation
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 30 Jan 2017
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mothers of 6-11 year olds being seen in primary care offices throughout Columbus, OH.
Who may be able to join
- Mother of a 6-11 year old child
Who cannot join
- Unable to speak and read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
In response to the high prevalence rates of childhood obesity in central Ohio, the Center for Healthy Weight and Nutrition (CHWN) established the Primary Care Obesity Network (PCON); a partnership between primary care physicians and Nationwide Children's Hospital's Center for Healthy Weight and Nutrition, a tertiary care obesity center, the first of its kind in Ohio. The overall goal of PCON is to bring an effective and user friendly obesity management program to the community physician's office to prevent and treat the growing number of obese children in the setting of the private office. The predominant nutrition messaging approach to tackling childhood obesity has revolved around the food choices and portion sizes. While this is relevant, an area with significant potential for impact for maintaining optimal growth and a healthy weight for young children is addressing feeding behaviors and self-regulation of intake;. - the "how" of eating. The investigators objective it to investigate whether this self-regulation approach can be employed for an older age group of 6-11 years old.
- Conditions
- Self-regulation
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mothers of 6-11 year olds | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examining use of disordered self-regulatory feeding behaviors, at survey completion
Measured: At survey completion, which will occur about 30 minutes after the survey is administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJul 2013
- Primary completion30 Jan 2017
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-regulationStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Ihuoma Eneli, Nationwide Children's Hospital
- Investigators
- ihuoma Eneli, MD, Principal investigator, Nationwide Childrens Hospital, Columbus, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206191
- Sponsor's protocol ID
- IRB13-00262
- Other IDs
- Food Innovation Center
- Acronym
- PCON
- Status last verified
- Mar 2018
- First submitted
- 21 Jul 2014
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Primary Care Obesity Network (PCON): Incorporating Principles of Self-regulation of Intake
- ClinicalTrials.gov ID
- NCT02206191
- Acronym / sponsor ID
- PCON / IRB13-00262
- Conditions
- Self-regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- Jul 2013
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 1 Aug 2014 (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 response to the high prevalence rates of childhood obesity in central Ohio, the Center for Healthy Weight and Nutrition (CHWN) established the Primary Care Obesity Network (PCON); a partnership between primary care physicians and Nationwide Children's Hospital's Center for Healthy Weight and Nutrition, a tertiary care obesity center, the first of its kind in Ohio. The overall goal of PCON is to bring an effective and user friendly obesity management program to the community physician's office to prevent and treat the growing number of obese children in the setting of the private office. The predominant nutrition messaging approach to tackling childhood obesity has revolved around the food choices and portion sizes. While this is relevant, an area with significant potential for impact for maintaining optimal growth and a healthy weight for young children is addressing feeding behaviors and self-regulation of intake;. - the "how" of eating. The investigators objective it to investigate whether this self-regulation approach can be employed for an older age group of 6-11 years old.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mothers of 6-11 year olds | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers of 6-11 year olds being seen in primary care offices throughout Columbus, OH.
Key inclusion criteria (1 listed)
- Mother of a 6-11 year old child
Key exclusion criteria (1 listed)
- Unable to speak and read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Examining use of disordered self-regulatory feeding behaviors, at survey completion
Time frame: At survey completion, which will occur about 30 minutes after the survey is administered
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 30 Mar 2018.
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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.
ihuoma Eneli, MD principal investigator
Nationwide Childrens Hospital, Columbus, Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self-regulation, run by Nationwide Children's Hospital 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 1 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 30 Mar 2018. 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?
Examining use of disordered self-regulatory feeding behaviors, at survey completion (time frame: At survey completion, which will occur about 30 minutes after the survey is administered). 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 30 Mar 2018.