Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-10 @ 3:37 PM
Study NCT ID:
NCT06595056
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-31
First Post:
2024-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens: Chicas Fuertes 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Meeting guidelines for physical activity', 'timeFrame': '6 months', 'description': 'Proportion of participants meeting guidelines of 60 min/day of moderate to vigorous physical activity (MVPA) measured by accelerometers'}], 'secondaryOutcomes': [{'measure': 'Maintenance of MVPA', 'timeFrame': '12 months', 'description': 'Proportion of participants meeting guidelines of 60 minutes/day of MVPA measured by accelerometers.'}, {'measure': 'Processes of Change for Physical Activity (POC)', 'timeFrame': '12 months', 'description': 'Questionnaire that tracks cognitive and behavioral processes related to MVPA change'}, {'measure': 'Stages of Change for Physical Activity (SCPA)', 'timeFrame': '12 months', 'description': 'Questionnaire that determines what stage of exercise engagement the participant is currently in (precontemplation, contemplation, preparation, action, maintenance), and is used to stage-match treatment.'}, {'measure': 'Self-Efficacy for Physical Activity (SE)', 'timeFrame': '12 months', 'description': 'Questionnaire that measures self-efficacy to become physically active across diverse contexts'}, {'measure': 'Social Support for Exercise (SSE)', 'timeFrame': '12 months', 'description': 'Questionnaire measuring social support specifically in relation to exercise with three subscales (friends, family, rewards/punishments)'}, {'measure': 'Outcome Expectations Scale', 'timeFrame': '12 months', 'description': 'Questionnaire that measures the beliefs regarding the consequences of physical activity participation'}, {'measure': 'Technology Engagment', 'timeFrame': '12 months', 'description': 'Tracks activity on the study website (logins, goal setting, questionnaires answered), Fitbit activity (days worn, sync frequency), texting activity (% of interactive texts responded to), Instagram activity (views, likes)'}, {'measure': 'Neighborhood Environment Walkability Scale for Youth (NEWS-Y)', 'timeFrame': 'Baseline', 'description': 'Questionnaire that measures perceptions of neighborhood environment including recreation facility availability, pedestrian traffic safety, and walking facilities'}, {'measure': 'Vital Signs', 'timeFrame': '12 months', 'description': 'Height, weight, resting blood pressure'}, {'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': '12 months', 'description': 'Questionnaire used to assess stress levels'}, {'measure': 'Demographics', 'timeFrame': 'Baseline', 'description': 'Age, race, parent education and income, marital status, acculturation'}, {'measure': 'Physical Activity Enjoyment Scale (PACES)', 'timeFrame': '12 months', 'description': 'Questionnaire that assesses level of personal satisfaction from physical activity'}, {'measure': 'Childrens Depression Inventory (CDI)', 'timeFrame': '12 months', 'description': 'Questionnaire that measures affective, cognitive, motivational, and somatic symptoms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescent health', 'Latina', 'teenager', 'mHealth', 'fitness tracker'], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '34128823', 'type': 'BACKGROUND', 'citation': 'Larsen B, Greenstadt ED, Olesen BL, Marcus BH, Godino J, Zive MM. An mHealth Physical Activity Intervention for Latina Adolescents: Iterative Design of the Chicas Fuertes Study. JMIR Form Res. 2021 Jun 15;5(6):e26195. doi: 10.2196/26195.'}]}, 'descriptionModule': {'briefSummary': 'This study will test a physical activity intervention for Latina teenagers. Investigators will recruit 200 Latina adolescents who are currently under-active to participate in this 12-month study. Participants will be referred to the study by their primary care provider. Half of the participants will be randomly selected for the Intervention group, and will receive an individual counseling session and access to a personalized website. These participants will also receive a Fitbit activity tracker to help with goal setting and monitoring, plus weekly text messages and access to the study Instagram account to remind participants to be physically active. Those assigned to the control group will receive the Fitbit activity tracker.', 'detailedDescription': 'This study will conduct a randomized trial to evaluate the efficacy of a theory-based, individually tailored, multi-technology intervention on increasing physical activity in Latina adolescents, compared to a control group receiving only a physical activity tracker (a Fitbit). The study team will recruit adolescent (age 13-17) Latinas (N=200) who are currently under-active to participate in the 12-month trial. Those randomized to the Intervention arm will receive a one-on-one counseling session and access to an individually tailored multi-media website. Key intervention components will be reinforced through text messaging to aid goal setting, a physical activity tracker (Fitbit) to set goals, track and log activity, and access to a study Instagram account to reinforce exposure to web content. The primary outcome will be increases in moderate-to-vigorous activity between baseline and 6 months. Secondary outcomes will include changes in activity at 12 months, potential mediators of the intervention, costs of delivering the intervention, behavior change trajectories from continuous data from Fitbits, potential moderators, and changes in physiological and psychological variables.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self identify as Latina\n* age 13-17\n* read, write, and speak English\n* be a current patient at FHCSD\n* be under-active (engaging in 60 min/day of MVPA on fewer than 5 days per week)\n* regular access (≥2 times/week) to Internet and a smart phone that can receive text messages\n\nExclusion Criteria:\n\n* unwillingness to be randomized to one of the two conditions\n* self-reporting any condition that would impair ability to participate in physical activity for at least 10 minutes at a time'}, 'identificationModule': {'nctId': 'NCT06595056', 'briefTitle': 'Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens: Chicas Fuertes 2', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens: Chicas Fuertes 2', 'orgStudyIdInfo': {'id': '810268'}, 'secondaryIdInfos': [{'id': 'R01HL171807', 'link': 'https://reporter.nih.gov/quickSearch/R01HL171807', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants will receive a one-on-one counseling session and access to an individually tailored multi-media website. Key intervention components will be reinforced through text messaging to aid goal setting, a physical activity tracker (Fitbit) to set goals, track and log activity, and access to a study Instagram account to reinforce exposure to web content.', 'interventionNames': ['Behavioral: Multi-technology MVPA intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will receive a physical activity tracker (Fitbit) only.'}], 'interventions': [{'name': 'Multi-technology MVPA intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a one-on-one counseling session and access to an individually tailored multi-media website. Key intervention components will be reinforced through text messaging to aid goal setting, a physical activity tracker (Fitbit) to set goals, track and log activity, and access to a study Instagram account to reinforce exposure to web content.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California- San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 7 years after the end of the funding period.', 'ipdSharing': 'YES', 'description': 'All quantitative data produced in the course of the project will be preserved and shared. Transcripts from stakeholder interviews will be shared only in the event that they give permission for the entire transcript to be shared; otherwise, summaries and codebooks will be shared.', 'accessCriteria': 'The Larsen USCD data provides metadata, persistent identifiers and long-term access. This repository is supported by USCD and dataset(s) are available through a request process directly with the PI, Dr. Larsen.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Family Health Centers of San Diego', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Britta Larsen', 'investigatorAffiliation': 'University of California, San Diego'}}}}