Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-01-31 @ 10:22 AM
Study NCT ID:
NCT03135561
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2017-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pedometer-based Intervention With and Without Email Counselling in General Practice
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'health-related quality of life', 'timeFrame': '12 weeks', 'description': 'assessed with the 36-Item Short Form Health Survey (SF-36)'}, {'measure': 'anxiety', 'timeFrame': '12 weeks', 'description': 'assessed with the anxiety subscale of the Hospital Anxiety and Depression Scale'}, {'measure': 'depression', 'timeFrame': '12 weeks', 'description': 'assessed with the depression subscale of the Hospital Anxiety and Depression Scale'}, {'measure': 'self-efficacy', 'timeFrame': '12 weeks', 'description': 'assessed with the Czech version of the General Self-Efficacy scale'}], 'primaryOutcomes': [{'measure': 'average daily step count', 'timeFrame': '12 weeks', 'description': 'change in average daily steps measured during 7-day period at baseline and at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'body weight', 'timeFrame': '12 weeks', 'description': 'measured to the nearest kg'}, {'measure': 'systolic blood pressure', 'timeFrame': '12 weeks', 'description': 'measured to the nearest mmHg'}, {'measure': 'diastolic blood pressure', 'timeFrame': '12 weeks', 'description': 'measured to the nearest mmHg'}, {'measure': 'waist circumference', 'timeFrame': '12 weeks', 'description': 'recorded with a measurement tape to the nearest cm'}, {'measure': 'hip circumference', 'timeFrame': '12 weeks', 'description': 'recorded with a measurement tape to the nearest cm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity', 'Primary Care', 'General Practice']}, 'referencesModule': {'references': [{'pmid': '29769107', 'type': 'DERIVED', 'citation': 'Vetrovsky T, Cupka J, Dudek M, Kuthanova B, Vetrovska K, Capek V, Bunc V. A pedometer-based walking intervention with and without email counseling in general practice: a pilot randomized controlled trial. BMC Public Health. 2018 May 16;18(1):635. doi: 10.1186/s12889-018-5520-8.'}]}, 'descriptionModule': {'briefSummary': 'A two-arm parallel randomised controlled trial comparing pedometer-based intervention with and without email counselling in a primary care setting. Physically inactive patients from four general practices will be randomised to the pedometer-plus-email group or to the pedometer-alone group. All patients will be instructed to gradually increase the daily number of steps to at least 10,000. Patients in the pedometer-plus-email group will receive 8 counselling emails based on behavioural techniques. The primary outcome will be change in average daily steps measured during 7-day period at baseline and at 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physically inactive, i.e. takes less than 8,000 steps per day at baseline\n* registered at the participating general practice,\n* over 18 years of age,\n* regular email user, and willing to use email for the purpose of the study,\n* has a home computer with access to the Internet.\n\nExclusion Criteria:\n\n* medical or psychiatric condition which the general practitioner considers as inappropriate for participating in the intervention (e.g., terminal illness, psychotic illness, chronic disorders or diseases that seriously influence the ability to be physically active, dementia or significant cognitive impairment, unable to move about independently),\n* medical, personal of family condition which the general practitioner considers temporarily affects mean daily step count at baseline (e.g., acute illness, holiday or business trip),\n* pregnant woman,\n* currently engaging in regular sports or exercise (at least twice a week),\n* failure to upload pedometer data to a website at baseline assessment,\n* failure to give informed consent with the study.'}, 'identificationModule': {'nctId': 'NCT03135561', 'briefTitle': 'A Pedometer-based Intervention With and Without Email Counselling in General Practice', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'A Pedometer-based Walking Intervention With and Without Email Counselling in General Practice: a Pilot Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'Pedometer-plus-email'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pedometer-plus-email', 'interventionNames': ['Behavioral: pedometer-plus-email']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pedometer-only', 'interventionNames': ['Behavioral: pedometer-only']}], 'interventions': [{'name': 'pedometer-plus-email', 'type': 'BEHAVIORAL', 'description': 'After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. During the intervention period, patients will receive 8 counselling emails based on behavioural techniques.', 'armGroupLabels': ['pedometer-plus-email']}, {'name': 'pedometer-only', 'type': 'BEHAVIORAL', 'description': 'After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. There will be no further interaction during the intervention period unless they fail to upload data, in which case they will be offered technical support.', 'armGroupLabels': ['pedometer-only']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tomas Vetrovsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Czech Republic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Tomáš Větrovský', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}