Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-10 @ 3:38 PM
Study NCT ID:
NCT06438003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-08
First Post:
2024-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Healthy Living Opportunities: Laurel HARVEST
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-14', 'size': 330508, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-03T10:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in food security', 'timeFrame': 'Baseline (year 1) and year 3', 'description': "Food Security Status will be measured at each time point by the 10-item United States Department of Agriculture (USDA) Household Food Security Module. The questionnaire includes ten questions pertaining to food security that were designed to assess an individual's ability to obtain food directly to ensure having enough healthy food to eat. The questions include items such as not having enough money to purchase food, inability to afford nutritious food, and skipping meals due to lack of sufficient money. Answer choices include often, sometimes, never, and don't know. Items will be scored Food security status is assigned as follows: raw score zero-High food security among adults, raw score 1-2-Marginal food security, raw score 3-5-Low food security, raw score 6-10-Very low food security. For some reporting purposes, the food security status of the first two categories in combination will be described as food secure and the latter two as food insecure."}, {'measure': 'change in total Healthy Eating Index scores', 'timeFrame': 'Baseline (year 1) and year 3', 'description': 'The Healthy Eating Index is a measurement that can capture changes in the thirteen dietary components outlined in the Dietary Guidelines for Americans. A maximum score-5 or 10 points- can be reached for each dietary component, depending on the component. Points are awarded when the amounts consumed meets the standard for a particular dietary component. Amounts that do not meet the standard get fewer points, with zero being the minimum score, and the maximum total Healthy Eating Index score is 100.'}, {'measure': 'Change in Food and Physical Activity Questionnaire (FPAQ)', 'timeFrame': 'Baseline (year 1) and year 3', 'description': '30 item questionnaire to collect self-reported behaviors pertaining to five domains: diet, physical activity, food safety, food security and food resource management. The response options for each question are based on a Likert scale. Each question is scored with higher scores indicating greater frequency of the behavior in question.'}, {'measure': 'change in carotenoids', 'timeFrame': 'Baseline (year 1) and year 3', 'description': 'the VEGGIE METER™ will be used to measure dermal carotenoids using non-invasive RS Spectroscopy. Carotenoids are a biological marker of fruit and vegetable consumption. This non-invasive measurement of dermal carotenoids has been validated against the standard of serum carotenoids in adults. To obtain the measurement, a subject places their pointer finger into the machine for 20 seconds while their finger is squeezed. Three replicates will be taken per person at 20 seconds per replicate. The VEGGIE METER™ scores dermal carotenoids on a scale of 0-850 with higher scores indicating higher intake.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Equity', 'Food Insecurity', 'Rural'], 'conditions': ['Health Knowledge, Attitudes, Practice', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The goal of this pre-post intervention study is to understand how community-engaged approaches to policy, systems, and environmental approaches can work to improve fruit and vegetable consumption and food security status among an Appalachian Kentucky community. The main approaches taken will be to employ a Community Advisory Board to define our target population of need, and appropriate intervention strategies. The investigators aim to understand if nutrition-based programming and food system approaches for lower-income, single-parent households, and multi-generational households can improve health. Participants will engage in annual data collection to assess dietary quality and food security status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of Laurel of Pike County\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Pregnancy\n* Non-English speaking\n* Plans to move out of the counties within the next three years'}, 'identificationModule': {'nctId': 'NCT06438003', 'briefTitle': 'Improving Healthy Living Opportunities: Laurel HARVEST', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Improving Healthy Living Opportunities: Laurel HARVEST', 'orgStudyIdInfo': {'id': '64602'}, 'secondaryIdInfos': [{'id': '2022-68015-36497', 'type': 'OTHER_GRANT', 'domain': 'USDA NIFA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laurel County', 'description': 'Specialized services', 'interventionNames': ['Behavioral: Special Services']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pike County', 'description': 'Extension services as usual', 'interventionNames': ['Other: Services as Usual']}], 'interventions': [{'name': 'Special Services', 'type': 'BEHAVIORAL', 'description': 'Community members will complete data collection at the extension office or community partner location. Extension cooking classes and helping to make raised bed gardens along with other area happenings will be offered to participants throughout the year with check-ins and reminders. Data will be collected from study participants (regardless of the intervention decided) , at two time points, to include survey, dietary recall, and carotenoid scanner.', 'armGroupLabels': ['Laurel County']}, {'name': 'Services as Usual', 'type': 'OTHER', 'description': 'Community members will receive extension services as usual with Data collection on participants at two time points to assess changes in rates of food insecurity, dietary quality, and overall health conditions.', 'armGroupLabels': ['Pike County']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Makenzie Barr-Porter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makenzie Barr-Porter', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Makenzie Barr-Porter', 'investigatorAffiliation': 'University of Kentucky'}}}}