Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT05472402
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2022-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The R21 phase will use 4 focus groups with 48 black women, and feedback from 12 expert advisors to modify content from our existing evidence-based PA curriculum for online implementation. - This phase has been completed.\n\nThe R33 phase will use a randomized controlled trial design to implement a pilot study to evaluate the feasibility, acceptability, and impact on PA of the online PA curriculum.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily step counts', 'timeFrame': 'Baseline and immediately post intervention', 'description': 'Daily walking over 14 consecutive days'}, {'measure': 'Bouts of moderate-to-vigorous physical activity', 'timeFrame': 'Baseline and immediately post intervention', 'description': 'Daily bouts over 14 consecutive days using a wrist-worn accelerometer'}], 'secondaryOutcomes': [{'measure': 'Sedentary behavior', 'timeFrame': 'Baseline and immediately post intervention', 'description': 'Daily bouts over 14 consecutive days using a wrist-worn accelerometer'}, {'measure': 'Self-reported physical activity', 'timeFrame': 'Baseline and immediately post intervention', 'description': 'Participant reported using the 7-item self-administered modifided International Physical Activity Questionnaire'}, {'measure': 'Clinical measures', 'timeFrame': 'Baseline and immediately post intervention', 'description': 'Height, weight, seated blood pressure, waist circumference'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedentary Behavior', 'Lack of Physical Activity', 'Physical Inactivity']}, 'descriptionModule': {'briefSummary': 'This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation.', 'detailedDescription': 'Research demonstrates the health-related benefits of participation in daily physical activity (PA), including prevention and treatment of chronic diseases. Despite this knowledge, the majority of US adults, particularly black women, do not achieve recommended levels of PA and, consequently, have higher rates of related chronic disease. An efficacy study led by the proposed Principal Investigator developed and tested an in person, 10-month group-based faith-integrated (FI) or secular (SEC) PA intervention, compared with a self-guided control (SG) for black women. Both FI and SEC were superior to SG for increasing daily steps after 10 months, and FI was superior to SG for increasing daily steps 12 months post intervention. Barriers to program participation noted by participants included childcare and work responsibilities and proximity to the group meeting location. The 2018 PA Guidelines Advisory Committee Scientific Report highlighted the need for effective strategies to promote PA, including internet-delivered interventions which have demonstrated strong evidence for effectiveness at increasing PA levels. Limited data exist regarding the efficacy of internet-delivered interventions in racial/ethnic minority groups. Online delivery of our evidence-based program may increase reach and address known barriers to PA program participation in black women. This project will explore strategies for adapting the program for web-based delivery of the existing curriculum. R21 phase aims are: Aim 1: Solicit input from individuals representative of the population of focus to inform the translation of the FI curriculum for online use; Aim 2: Use the knowledge gathered in Aim 1 to adapt existing FI and SG curricula for online use; Aim 3: Assess acceptability of the online curricula in an advisory group similar to the target population. Investigators will conduct focus groups with black women to understand factors that would influence online delivery of the curriculum. A 12-member advisory group will be convened to assist with developing materials/strategies to adapt the curriculum for online delivery. In an iterative approach where material is tested, refined, and retested until complete, investigators will engage the advisory group in feasibility testing of the online curriculum'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-reported female', 'healthyVolunteers': True, 'eligibilityCriteria': '1. self-identified female\n2. black/African American\n3. \\> 18 years of age\n4. self-reported low active (i.e., achieving \\< 150 minutes per week of moderate-to-vigorous physical activity)\n5. no physical limitations or medical conditions that would be impacted by physical activity\n6. own a smartphone or computer with reliable high speed internet access\n7. able to speak and read English fluently; 8) potentially interested in participating in an online health intervention.'}, 'identificationModule': {'nctId': 'NCT05472402', 'acronym': 'LADIES Online', 'briefTitle': 'Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women', 'organization': {'class': 'OTHER', 'fullName': 'Gramercy Research Group'}, 'officialTitle': 'Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women', 'orgStudyIdInfo': {'id': 'R21AG070657', 'link': 'https://reporter.nih.gov/quickSearch/R21AG070657', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LADIES online intervention (R33 phase)', 'description': 'Participants will include 30 women who will be randomized to receive six (6) months of online group-based intervention sessions that teach participants how to increase physical activity levels.', 'interventionNames': ['Behavioral: LADIES online intervention (R33 phase)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LADIES online control (R33 phase)', 'description': 'Participants will include 30 women who will be randomized to receive self-guided materials that teach participants how to increase physical activity levels. Placebo comparator participants will receive their materials via the online platform.', 'interventionNames': ['Behavioral: LADIES online control (R33 phase)']}], 'interventions': [{'name': 'LADIES online intervention (R33 phase)', 'type': 'BEHAVIORAL', 'otherNames': ['LADIES online'], 'description': 'Participants will participate weekly online group sessions over 6 months. Participants will also receive access to written intervention materials, access to an online walking program, and access to weekly podcasts that are aligned with the intervention sessions and that support physical activity lessons with biblical scriptures.', 'armGroupLabels': ['LADIES online intervention (R33 phase)']}, {'name': 'LADIES online control (R33 phase)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive online access to a written self-guided curriculum that is self-paced and teaches participants how to increase physical activity. Participants will be encouraged to complete the self-guided curriculum within 6 months.', 'armGroupLabels': ['LADIES online control (R33 phase)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27545', 'city': 'Knightdale', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Gramercy Research Group', 'geoPoint': {'lat': 35.78765, 'lon': -78.48056}}], 'overallOfficials': [{'name': 'Melicia Whitt-Glover, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gramercy Research Group'}, {'name': 'Robert Newton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gramercy Research Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President & CEO', 'investigatorFullName': 'Melicia Whitt-Glover', 'investigatorAffiliation': 'Gramercy Research Group'}}}}