Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2026-01-29 @ 3:48 AM
Study NCT ID:
NCT01480466
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2011-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2011-11-21', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Primary care clinician attitudes about management of overweight and obesity', 'timeFrame': 'baseline, 12 months', 'description': 'Primary care clinician attitudes about management of overweight and obesity, assessed via an electronic survey'}, {'measure': 'Patient attitudes and behaviors around weight management', 'timeFrame': 'baseline, 6 months', 'description': 'Patient attitudes, beliefs, and behaviors around weight management (including diet, physical activity)'}], 'primaryOutcomes': [{'measure': 'weight change over 6 months', 'timeFrame': 'Baseline, 6 months', 'description': 'Change in weight from first visit during Stage 2 of intervention period until approximately 6 months later, among patients with BMI \\>= 25'}, {'measure': 'weight change over 12 months', 'timeFrame': 'Baseline, 12 months', 'description': 'Change in weight from first visit during Stage 2 of intervention period until approximately 12 months later, among patients with BMI \\>= 25'}], 'secondaryOutcomes': [{'measure': 'Documentation of height', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Percentage of patients with height recorded in the electronic health record'}, {'measure': 'Documentation of weight', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Percentage of patients with weight recorded in electronic health record within past year'}, {'measure': 'Documentation of body mass index', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Percentage of patients with body mass index calculated in electronic health record within past year'}, {'measure': 'Diagnosis of overweight and obesity', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Percentage of patients with BMI \\>= 25 with Overweight or Obesity on the Problem List in the electronic health record'}, {'measure': 'Management of overweight and obesity', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Percentage of patients with BMI \\>= 25 with evidence of treatment for overweight or obesity in the electronic health record'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Body mass index', 'Weight', 'Primary care'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '25810449', 'type': 'DERIVED', 'citation': 'Baer HJ, Wee CC, DeVito K, Orav EJ, Frolkis JP, Williams DH, Wright A, Bates DW. Design of a cluster-randomized trial of electronic health record-based tools to address overweight and obesity in primary care. Clin Trials. 2015 Aug;12(4):374-83. doi: 10.1177/1740774515578132. Epub 2015 Mar 25.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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"}, 'identificationModule': {'nctId': 'NCT01480466', 'briefTitle': 'Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care', 'orgStudyIdInfo': {'id': 'K01HS019789', 'link': 'https://reporter.nih.gov/quickSearch/K01HS019789', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obesity tools in electronic health record', 'description': '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.', 'interventionNames': ['Other: Obesity tools in the electronic health record']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'This arm is standard care for overweight/obesity.'}], 'interventions': [{'name': 'Obesity tools in the electronic health record', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Obesity tools in electronic health record']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Heather J Baer, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, {'name': 'Boston Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Epidemiologist', 'investigatorFullName': 'Heather J. Baer', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}