Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT04086420
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2019-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-Based Physical Activity Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D006339', 'term': 'Heart Rate'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Minutes', 'timeFrame': '1-Week Follow-Up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mindfulness', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '33165218', 'type': 'DERIVED', 'citation': 'Sala M, Geary B, Baldwin AS. A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study. Psychosom Med. 2021 Jul-Aug 01;83(6):615-623. doi: 10.1097/PSY.0000000000000885.'}]}, 'descriptionModule': {'briefSummary': 'The aims of this parallel two-arm pilot randomized controlled trial is to assess the feasibility and acceptability of an audio-recorded mindfulness-based intervention and to assess whether the intervention results in a clinically meaningful difference in physical activity compared to the control condition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Reported less than 60-minutes of weekly moderate-to-vigorous physical activity (MVPA, moderate physical activity minutes + vigorous physical activity minutes\\*2)\n* Safe to exercise at moderate intensity without a doctor's approval according to American College of Sports Medicine Criteria\n* Had a smart phone to access the audio-recorded mindfulness-based physical activity intervention"}, 'identificationModule': {'nctId': 'NCT04086420', 'briefTitle': 'Mindfulness-Based Physical Activity Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Southern Methodist University'}, 'officialTitle': 'A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study', 'orgStudyIdInfo': {'id': 'H18-046 SALM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness', 'description': 'Delivered through an audio-recording consisting of a single meditation exercise that lasted for 30 minutes', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heart-Rate', 'description': 'Given a heart rate monitor and instructed to use it to determine the intensity of their exercise', 'interventionNames': ['Behavioral: Heart-Rate']}], 'interventions': [{'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': 'Received instructions to exercise at moderate intensity while listening to an audio-recorded mindfulness-based physical activity intervention', 'armGroupLabels': ['Mindfulness']}, {'name': 'Heart-Rate', 'type': 'BEHAVIORAL', 'description': 'Given a heart rate monitor, told to exercise within the moderate intensity range (64-76% of estimated maximum heart rate)', 'armGroupLabels': ['Heart-Rate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75205', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Southern Methodist University', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Methodist University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}