Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-27 @ 7:27 AM
Study NCT ID:
NCT01708135
Status:
COMPLETED
Last Update Posted:
2014-09-16
First Post:
2012-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Use of BariCare App in Pre-bariatric Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-15', 'studyFirstSubmitDate': '2012-10-08', 'studyFirstSubmitQcDate': '2012-10-15', 'lastUpdatePostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smart phone app feasibility', 'timeFrame': '3 months', 'description': 'All subjects will complete a Bariatric Surgery Questionnaire consisting of 30 questions that assess their knowldege in areas of nutrition, physical activity, and bariatric surgery. They will also be given a questionnaire on physical activity (International physical activity questionnaire or IPAQ). The primary objective is to assess improvement on both of these questionnaires with use of app.'}], 'secondaryOutcomes': [{'measure': 'Ease of use of app', 'timeFrame': '3 months', 'description': 'Through a questionnaire provided at the end of study, we will be gathering input from participants regarding ease of use of app, things they would like added or removed, as well as if they found modules helpful.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This current study aims to evaluate the efficacy of engagement modules in preparing patients for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app (Android and Apple compatible) has been created that will assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged during the lengthy pre-bariatric surgery process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients, who upon completion of an evaluation by Endocrinology, are considered appropriate to pursue a primary, laparoscopic bariatric surgery.\n2. Patients who are 18 years of age or greater.\n3. Patients who own a smartphone.\n\nExclusion Criteria:\n\n1. Patients with a history of a prior bariatric surgery.\n2. Patients with active psychiatric disorder(s).\n3. Patients with active tobacco use.\n4. Patients with active substance use (alcohol, illicit drugs, etc.)'}, 'identificationModule': {'nctId': 'NCT01708135', 'briefTitle': 'Feasibility of Use of BariCare App in Pre-bariatric Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Feasibility and Efficacy of Engagement Modules for Pre-Bariatric Surgery Patients.', 'orgStudyIdInfo': {'id': '12-005535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Smartphone Arm', 'description': 'This is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in preparing for bariatric surgery.', 'interventionNames': ['Behavioral: Use of smartphone app']}], 'interventions': [{'name': 'Use of smartphone app', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Smartphone Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Manpreet Mundi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Manpreet S. Mundi', 'investigatorAffiliation': 'Mayo Clinic'}}}}