Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT04651751
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2020-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Habit & MPAC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-11-25', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Environmental Cues (self report, survey question)', 'timeFrame': 'Baseline, week four, week eight', 'description': 'The following item was used to assess if participants implemented the use of cues: "I use cues at home to remind me to exercise (e.g. placing a water bottle on my desk or gym clothes on the bed). The item was rated on a five point Likert scale which ranged from "1=strongly disagree" to "5= strongly agree".'}, {'measure': 'Temporal Consistency (self report, survey question)', 'timeFrame': 'Baseline, week four, week eight', 'description': 'The item was worded "How consistently do you exercise at the same time each day? (e.g., exercising every morning at 7 am, or exercising daily after supper)". The question was asked on a five point Likert scale which range from "1=not consistent at all" to "5=very consistent".'}], 'primaryOutcomes': [{'measure': 'GT3X+ Actigraph Activity Monitors (for measuring physical activity)', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Participants wear accelerometers for one week at baseline and at week eight to record their physical activity.'}], 'secondaryOutcomes': [{'measure': '1.Self-Report Behavioural Automaticity Index (self report, survey question', 'timeFrame': 'Baseline, week four, week eight', 'description': "The Self-Report Behavioral Automaticity Index (SRBAI) was used to assess preparatory habit. The SRBAI consists of 4 items on a 5-point Likert scale with 1 being strongly disagree to 5 being strongly agree. The question stem stated ''When I prepare to exercise…'' which was then followed by four items on the scale: ''I do it without having to consciously remember'', ''I do it automatically'', ''I do it without thinking'', and ''I start before I realize I am doing it''."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Public Health']}, 'descriptionModule': {'briefSummary': 'The limitations of applying social cognitive models to understand physical activity (PA) have led to the emergence of several new PA models within the past decade. The Multi-Process Action Control (M-PAC) is a comprehensive PA model that proposes intention is established from outcome expectations, perceived capability, and opportunity, then the success of translating this to behavior depends on affective judgments and behavioral-regulation. Over time, M-PAC proposes that behavior is can become maintained through the formation of identity and habit. The purpose of this study was to investigate the trajectory of change of these M-PAC constructs across time in a randomized controlled trial. Participants (n=85) were inactive new gym members and were randomized into a control (n=41) or intervention (n=44) group. The intervention group attended a workshop and received a booster phone call follow-up at week four. Measures for both groups included accelerometry and M-PAC at baseline and eight week follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults 18-65\n* new gym members\n* exercising \\< 150 minutes/week at a moderate to vigorous level\n\nExclusion Criteria:\n\n* not affiliated with a gym or recreation center\n* exercising \\> 150 minutes/week at a moderate to vigorous level\n* clinical health conditions (assessed by the PAR-Q)'}, 'identificationModule': {'nctId': 'NCT04651751', 'briefTitle': 'Exercise Habit & MPAC', 'organization': {'class': 'OTHER', 'fullName': 'University of Victoria'}, 'officialTitle': 'Facilitating an Exercise Habit and Identity Via the Multi-Process Action Control Model- A Randomized-Controlled Trial', 'orgStudyIdInfo': {'id': 'AT956'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No Intervention: Control Participants exercised on their own without receiving any instructions.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Those who were randomized into the intervention group attended a workshop where the PI delivered a presentation that focused on establishing a preparatory exercise habit by using the M-PAC approach and proposed habit model. Participants were then provided with instructions on completing their exercise plan sheet.', 'interventionNames': ['Behavioral: Facilitating an Exercise Habit and Identity via the Multi-Process Action Control Model- A Randomized-Controlled Trial']}], 'interventions': [{'name': 'Facilitating an Exercise Habit and Identity via the Multi-Process Action Control Model- A Randomized-Controlled Trial', 'type': 'BEHAVIORAL', 'description': 'Participants attended a workshop which consisted of a presentation and an exercise planning exercise.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ryan E Rhodes, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Victoria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Victoria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ryan Rhodes', 'investigatorAffiliation': 'University of Victoria'}}}}