OverweightNCT00973661
Electronic Tools to Assist With Identification of and Counseling for Overweight Patients
A study testing Electronic tool set for counseling overweight patients in people with Overweight, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to design and assess the impact of an electronic alert and tool set to assist with physician identification and counseling of overweight patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight
- What is being tested?
- Electronic tool set for counseling overweight patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2010
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting physicians from the Northwestern Memorial General Internal Medicine (NMFF GIM) practice
- Adults ages 18-65 seen at the NMFF GIM who are patients of consenting physicians
- Have at least one appointment at the NMFF GIM clinic between 9/1/09-2/28/10
- Body mass index (BMI) 27-29.9 at one or more visits between 9/1/09-2/28/10
Who cannot join
- Study investigators will be excluded from participation (Dr. David Baker, Dr. Joyce Tang)
- Patients without at least one recorded height measurement from any prior visit or without weight information from a visit within the 6 month target window will be excluded due to inability to calculate BMI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Faculty Foundation General Internal Medicine Clinic
Chicago, Illinois, 60611
About this study
The purpose of this study is to design and assess the impact of an electronic alert and tool set to assist with physician identification and counseling of overweight patients.
Read the detailed description
Overweight adults (Body Mass Index [BMI] 25-29.9) are at high risk for developing obesity, but rates of physician identification and counseling of overweight adults are low. Alerts and tools embedded in the electronic medical record have shown promise in enhancing quality improvement efforts.
Our aim is to design and assess the impact of an electronic alert and tool set to assist with identification and counseling of overweight patients with a BMI 27-29.9. Although the category of overweight patients spans BMI 25-29.9, we are including only patients with BMI 27-29.9 in order to focus resources on the most at-risk pre-obese population.
We will develop a tool set including the following components: automatic calculation of BMI, alert for overweight status, counseling template for weight loss goal-setting, linkage to referral options, and access to relevant patient handouts. Physicians in the Northwestern Memorial Faculty Foundation General Internal Medicine (NMFF GIM) practice who consent to participate in the study will be randomized into two groups, with one group of physicians receiving access to these tools. The other group of physicians will continue to provide their usual care for overweight patients. Outcome measures will include the following: tool usage; documentation of overweight in the problem list, encounter diagnosis, or note text; counseling for overweight and documentation of specific behavioral goals. Measures will be obtained via retrospective chart review.
- Conditions
- Overweight
- Being tested
- Electronic tool set for counseling overweight patients
- Keywords
- Overweight, Diagnosis, Counseling, Medical Records Systems, Computerized
- Medical subject headings
- Overweight, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic tool set for counseling overweight patientsBehavioural
Physicians randomized to the "electronic tools" arm will receive access to a tool set to aid with counseling of overweight patients. This tool set includes the following components: automatic calculation of BMI, alert for overweight status, counseling template for weight loss goal-setting, linkage to referral options, and access to relevant patient handouts. Physicians randomized to the "usual care" arm will not receive access to these tools, and will continue to provide their usual care for overweight patients.
| Study group | Role | What they receive |
|---|---|---|
| Electronic tools | Experimental | Not described Receives: Behavioral: Electronic tool set for counseling overweight patients |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented diagnosis of overweight
Measured: September 1, 2009-February 28, 2010
Secondary outcomes (2)
Documented counseling for overweight.
Measured: September 1, 2009-February 28, 2010
Documentation of specific behavior change goals
Measured: September 1, 2009-February 28, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
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 Northwestern 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Joyce W Tang, MD, Principal investigator, Northwestern University, Department of General Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973661
- Sponsor's protocol ID
- STU00013264
- Status last verified
- Jul 2011
- First submitted
- 8 Sep 2009
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Tools to Assist With Identification of and Counseling for Overweight Patients
- ClinicalTrials.gov ID
- NCT00973661
- Acronym / sponsor ID
- STU00013264
- Conditions
- Overweight
- Keywords
- Overweight, Diagnosis, Counseling, Medical Records Systems, Computerized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Sep 2009 (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.
The purpose of this study is to design and assess the impact of an electronic alert and tool set to assist with physician identification and counseling of overweight patients.
Detailed description
Overweight adults (Body Mass Index [BMI] 25-29.9) are at high risk for developing obesity, but rates of physician identification and counseling of overweight adults are low. Alerts and tools embedded in the electronic medical record have shown promise in enhancing quality improvement efforts.
Our aim is to design and assess the impact of an electronic alert and tool set to assist with identification and counseling of overweight patients with a BMI 27-29.9. Although the category of overweight patients spans BMI 25-29.9, we are including only patients with BMI 27-29.9 in order to focus resources on the most at-risk pre-obese population.
We will develop a tool set including the following components: automatic calculation of BMI, alert for overweight status, counseling template for weight loss goal-setting, linkage to referral options, and access to relevant patient handouts. Physicians in the Northwestern Memorial Faculty Foundation General Internal Medicine (NMFF GIM) practice who consent to participate in the study will be randomized into two groups, with one group of physicians receiving access to these tools. The other group of physicians will continue to provide their usual care for overweight patients. Outcome measures will include the following: tool usage; documentation of overweight in the problem list, encounter diagnosis, or note text; counseling for overweight and documentation of specific behavioral goals. Measures will be obtained via retrospective chart review.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic tools | Experimental | Behavioral: Electronic tool set for counseling overweight patients |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consenting physicians from the Northwestern Memorial General Internal Medicine (NMFF GIM) practice
- Adults ages 18-65 seen at the NMFF GIM who are patients of consenting physicians
- Have at least one appointment at the NMFF GIM clinic between 9/1/09-2/28/10
- Body mass index (BMI) 27-29.9 at one or more visits between 9/1/09-2/28/10
Key exclusion criteria (2 listed)
- Study investigators will be excluded from participation (Dr. David Baker, Dr. Joyce Tang)
- Patients without at least one recorded height measurement from any prior visit or without weight information from a visit within the 6 month target window will be excluded due to inability to calculate BMI.
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 |
|---|---|---|
| Electronic tool set for counseling overweight patientsPhysicians randomized to the "electronic tools" arm will receive access to a tool set to aid with counseling of overweight patients. This tool set includes the following components: automatic calculation of BMI, alert for overweight status, counseling template for weight loss goal-setting, linkage to referral options, and access to relevant patient handouts. Physicians randomized to the "usual care" arm will not receive access to these tools, and will continue to provide their usual care for overweight patients. | Behavioural | Electronic tools |
Primary outcome
Documented diagnosis of overweight
Time frame: September 1, 2009-February 28, 2010
2 secondary outcomes
Documented counseling for overweight.
Time frame: September 1, 2009-February 28, 2010
Documentation of specific behavior change goals
Time frame: September 1, 2009-February 28, 2010
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 27 Jul 2011.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Joyce W Tang, MD principal investigator
Northwestern University, Department of General Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic tool set for counseling overweight patients in people with Overweight, run by Northwestern 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 4 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 27 Jul 2011. 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?
Documented diagnosis of overweight (time frame: September 1, 2009-February 28, 2010). 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 27 Jul 2011.