- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01480466
Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care
April 28, 2014 updated by: Heather J. Baer, Brigham and Women's Hospital
Overweight and obesity are highly significant clinical and public health issues, affecting more than two-thirds of adults in this country; however, primary care clinicians often do not document overweight or obesity or discuss weight management with their patients.
The objectives of the proposed research are to develop and evaluate a set of tools within electronic health records (EHRs) to assist primary care clinicians with the diagnosis and treatment of overweight and obesity and to help patients manage their weight.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65278
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All adult patients (ages >= 20 years) who have a visit at a primary care practice at Brigham and Women's Hospital during the intervention period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Obesity tools in electronic health record
This arm will consist of a new set of tools within the electronic health record to help primary care clinicians address overweight and obesity with their patients.
|
The intervention is a set of new tools within the Partners electronic health record that are designed to assist primary care clinicians with the assessment and management of overweight and obesity in their patients.
|
No Intervention: Standard care
This arm is standard care for overweight/obesity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight change over 6 months
Time Frame: Baseline, 6 months
|
Change in weight from first visit during Stage 2 of intervention period until approximately 6 months later, among patients with BMI >= 25
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Baseline, 6 months
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weight change over 12 months
Time Frame: Baseline, 12 months
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Change in weight from first visit during Stage 2 of intervention period until approximately 12 months later, among patients with BMI >= 25
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Baseline, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Documentation of height
Time Frame: Baseline, 6 months, 12 months
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Percentage of patients with height recorded in the electronic health record
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Baseline, 6 months, 12 months
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Documentation of weight
Time Frame: Baseline, 6 months, 12 months
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Percentage of patients with weight recorded in electronic health record within past year
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Baseline, 6 months, 12 months
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Documentation of body mass index
Time Frame: Baseline, 6 months, 12 months
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Percentage of patients with body mass index calculated in electronic health record within past year
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Baseline, 6 months, 12 months
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Diagnosis of overweight and obesity
Time Frame: Baseline, 6 months, 12 months
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Percentage of patients with BMI >= 25 with Overweight or Obesity on the Problem List in the electronic health record
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Baseline, 6 months, 12 months
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Management of overweight and obesity
Time Frame: Baseline, 6 months, 12 months
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Percentage of patients with BMI >= 25 with evidence of treatment for overweight or obesity in the electronic health record
|
Baseline, 6 months, 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary care clinician attitudes about management of overweight and obesity
Time Frame: baseline, 12 months
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Primary care clinician attitudes about management of overweight and obesity, assessed via an electronic survey
|
baseline, 12 months
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Patient attitudes and behaviors around weight management
Time Frame: baseline, 6 months
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Patient attitudes, beliefs, and behaviors around weight management (including diet, physical activity)
|
baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heather J Baer, ScD, Brigham and Women's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
November 21, 2011
First Submitted That Met QC Criteria
November 28, 2011
First Posted (Estimate)
November 29, 2011
Study Record Updates
Last Update Posted (Estimate)
April 29, 2014
Last Update Submitted That Met QC Criteria
April 28, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01HS019789 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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