Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-07 @ 9:05 AM
Study NCT ID:
NCT03095768
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Education and Nutrition Demonstration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavior Change from Baseline to 2 Months', 'timeFrame': '2 months', 'description': 'Food Frequency Surveys'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline BMI at 2 Months', 'timeFrame': '2 months', 'description': 'Body Mass Index (kg/m\\^2)'}, {'measure': 'Change from Baseline Waist Circumference at 2 Months', 'timeFrame': '2 months', 'description': 'Waist Circumference (cm)'}, {'measure': 'Change from Baseline Blood Pressure at 2 Months', 'timeFrame': '2 months', 'description': 'Blood Pressure (mmHg)'}, {'measure': 'Change from Baseline Glucose at 2 Months', 'timeFrame': '2 months', 'description': 'Point-of-care Glucose (mg/dL)'}, {'measure': 'Change from Baseline Cholesterol at 2 Months', 'timeFrame': '2 months', 'description': 'Point-of-care Cholesterol (mmol/L)'}, {'measure': 'Change in Quality of Life from Baseline to 2 Months', 'timeFrame': '2 months', 'description': 'SF-36 Survey'}, {'measure': 'Program Evaluation Survey', 'timeFrame': '2 months', 'description': 'Investigator-created Survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lifestyle', 'Nutrition', 'Cooking'], 'conditions': ['Chronic Disease']}, 'descriptionModule': {'briefSummary': 'The Center for Lifestyle Medicine at the Cleveland Clinic Wellness Institute has a proven track record of engaging patients in healthy living and eating through education, live cooking demonstrations / hands-on cooking classes, exercise and stress management programs.\n\nAs a result of the Community Health Needs Assessment, we are collaborating with Cleveland Clinic Community Outreach and 12th District Representative, John E. Barnes, Jr., to extend our expertise to the community of Warrensville Heights, Ohio.', 'detailedDescription': "The City of Warrensville Heights and The Cleveland Clinic are combining efforts to address the paucity of fresh and nutritious foods accessible to seniors in the Warrensville Heights community through a new program at the city's Civic and Senior Center. This program will combine healthy lifestyle education with nutrition demonstration using recipes that can be prepared in a blender. These recipes have been designed to be simple, delicious and easy to eat, and include smoothies, soups and even a few desserts! Our ultimate goal is to use both education and demonstration to promote a mindset change regarding community members' abilities to eat healthy.\n\nThe population in the Warrensville Heights community is aging, and there is a high prevalence of chronic diseases including hypertension, diabetes, obesity and kidney disease. A recent Community Health Needs Assessment (CHNA) identified engagement and participation in the promotion and maintenance of a healthy lifestyle as a major area for improvement. Currently there is very limited access to healthy foods in the immediate community of Warrensville Heights, and in many cases, the transportation costs required for residents to access those healthy foods is often financially unfeasible. It is clear from this CHNA that both access to and education about healthy food options is sorely needed in this community.\n\nThe Center for Lifestyle Medicine at the Cleveland Clinic Wellness Institute has a proven track record of engaging patients in healthy living and eating through education, live cooking demonstrations / hands-on cooking classes, exercise and stress management programs. In response to the CHNA and in collaboration with 12th District Representative, John E. Barnes, Jr., the BLENDS study will extend our expertise to the Warrensville Heights community."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Adults 55 years of age or older living in the neighborhoods of Warrensville Heights\n\nExclusion Criteria:\n\n1. Food allergies\n2. Celiac or non-Celiac gluten intolerance\n3. Travel plans that do not permit full participation in the intervention\n4. Recent unexplained weight loss (10 pounds or more in past 3 months)'}, 'identificationModule': {'nctId': 'NCT03095768', 'acronym': 'BLENDS', 'briefTitle': 'Lifestyle Education and Nutrition Demonstration', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Blending Lifestyle Education and Nutrition Demonstration for Seniors in the Warrensville Heights Community', 'orgStudyIdInfo': {'id': '17-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Lifestyle Education and Cooking Demonstration', 'interventionNames': ['Other: Lifestyle Education and Cooking Demonstration']}], 'interventions': [{'name': 'Lifestyle Education and Cooking Demonstration', 'type': 'OTHER', 'description': 'Participants will receive an interactive cooking demonstration as well as healthy lifestyle education', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44128', 'city': 'Warrensville Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Warrensville Heights Senior Center', 'geoPoint': {'lat': 41.43505, 'lon': -81.53623}}], 'overallOfficials': [{'name': 'Dana L Schneeberger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'City of Warrensville Heights', 'class': 'UNKNOWN'}, {'name': 'Ohio Department of Aging', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator', 'investigatorFullName': 'Linda Libertini', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}