OverweightCHICA GISNCT01567228
Delivering Geospatial Intelligence to Health Care Providers
A study testing CHICA GIS (enhanced electronic medical record) in people with Overweight, run by Indiana University at 1 site in United States.
Trial summary
Physician counseling for physical activity, dental services, and academic support services such as tutoring could be improved through physician knowledge of local community resources and physician counseling directing patients to such services that are near the patient's residential address. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Overweight
- What is being tested?
- CHICA GIS (enhanced electronic medical record)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,076 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2014
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Referrals to three community resources will be studied: dentists (children older than 1 year), after school tutoring services (children older than 7 years), and physical education programs (children older than 5 years).
Who cannot join
- Inability of parent to complete data collection instruments spoken (via telephone survey) or written in English or Spanish.
- Inability to participate in community based physical activity programs due to health related condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Wishard Health Services
Indianapolis, Indiana, 46202
About this study
Physician counseling for physical activity, dental services, and academic support services such as tutoring could be improved through physician knowledge of local community resources and physician counseling directing patients to such services that are near the patient's residential address. This study will test the hypothesis that an electronic medical record enhanced with geographic information systems can improved physician counseling for physical activity, dental services, and academic support services by identifying services that are near the patient's residential address and informing MD's of such info at the point of care.
- Conditions
- Overweight
- Being tested
- CHICA GIS (enhanced electronic medical record)
- Keywords
- obesity, overweight, dental caries, school problems, school failure, child BMI > 85th percentile, Needing dental preventive services, Needing academic support for school problems
- Medical subject headings
- Overweight, Obesity, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHICA GIS (enhanced electronic medical record)Other
Also called CHICA GIS
An electronic medical record enhanced with geographic information systems will assist physicians in directing patients to community resources for increasing physical activity, preventing dental caries or addressing school problems
| Study group | Role | What they receive |
|---|---|---|
| routine counseling (control group) | No intervention | Children will receive typical counseling for obesity prevention, dental caries prevention, or school problems per routine standards for pediatrician anticipatory guidance |
| CHICA GIS | Experimental | In randomly assigned experimental clinics, physicians will counsel patients to increase physical activity, seek dental care, or seek academic support services such as tutoring; this counseling will be assisted by an experimental intervention which consist of an electronic medical record that prompts specific counseling in conjunction with a geographic information system. The enhanced electronic medical record will map community resources to support physician counseling and lifestyle modification Receives: Other: CHICA GIS (enhanced electronic medical record) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved physician counseling
For the intervention clinics, data gathered by CHICA-GIS on the physician worksheet and just-in-time handouts will also allow us to determine the percentage of children who received behavioral counseling about dentistry, school performance, or physical activity by the physician, as well as the percentage of children who were referred to a community resource.
Measured: 6 months
Secondary outcomes (1)
User experience and satisfaction
Surveys will be administered at baseline and end of the trial (18 months) to the entire staff of each practice, in order to document how each practice is organized and provide detailed information about community referral processes. Staff will also be asked about their satisfaction with the CHICA system, CHICA-GIS (Intervention Clinics only), and the community referral module (Intervention Clinics only).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- None (open label)
- Enrolment
- 1,076 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Sponsor
- Investigators
- Gilbert C Liu, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567228
- Sponsor's protocol ID
- 1R01LM010923-01
- Other IDs
- 1R01LM010923-01
- Acronym
- CHICA GIS
- Status last verified
- Sep 2015
- First submitted
- 18 Jan 2012
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Geospatial Intelligence to Health Care Providers
- ClinicalTrials.gov ID
- NCT01567228
- Acronym / sponsor ID
- CHICA GIS / 1R01LM010923-01
- Conditions
- Overweight
- Keywords
- obesity, overweight, dental caries, school problems, school failure, child BMI > 85th percentile, Needing dental preventive services, Needing academic support for school problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,076 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Mar 2012 (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.
Physician counseling for physical activity, dental services, and academic support services such as tutoring could be improved through physician knowledge of local community resources and physician counseling directing patients to such services that are near the patient's residential address. This study will test the hypothesis that an electronic medical record enhanced with geographic information systems can improved physician counseling for physical activity, dental services, and academic support services by identifying services that are near the patient's residential address and informing MD's of such info at the point of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine counseling (control group) | No intervention | –Children will receive typical counseling for obesity prevention, dental caries prevention, or school problems per routine standards for pediatrician anticipatory guidance |
| CHICA GIS | Experimental | Other: CHICA GIS (enhanced electronic medical record)In randomly assigned experimental clinics, physicians will counsel patients to increase physical activity, seek dental care, or seek academic support services such as tutoring; this counseling will be assisted by an experimental intervention which consist of an electronic medical record that prompts specific counseling in conjunction with a geographic information system. The enhanced electronic medical record will map community resources to support physician counseling and lifestyle modification |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Referrals to three community resources will be studied: dentists (children older than 1 year), after school tutoring services (children older than 7 years), and physical education programs (children older than 5 years).
Key exclusion criteria (2 listed)
- Inability of parent to complete data collection instruments spoken (via telephone survey) or written in English or Spanish.
- Inability to participate in community based physical activity programs due to health related condition
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 |
|---|---|---|
| CHICA GIS (enhanced electronic medical record)Also: CHICA GISAn electronic medical record enhanced with geographic information systems will assist physicians in directing patients to community resources for increasing physical activity, preventing dental caries or addressing school problems | Other | CHICA GIS |
Primary outcome
Improved physician counseling
Time frame: 6 months
For the intervention clinics, data gathered by CHICA-GIS on the physician worksheet and just-in-time handouts will also allow us to determine the percentage of children who received behavioral counseling about dentistry, school performance, or physical activity by the physician, as well as the percentage of children who were referred to a community resource.
1 secondary outcome
User experience and satisfaction
Time frame: 24 months
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 16 Sep 2015.
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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.
Gilbert C Liu, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHICA GIS (enhanced electronic medical record) in people with Overweight, run by Indiana University 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 2 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 Sep 2015. 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?
Improved physician counseling (time frame: 6 months). 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 16 Sep 2015.