Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT05392218
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2022-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Behavioral Intervention to Promote Healthy Lifestyle Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-22', 'studyFirstSubmitDate': '2022-05-09', 'studyFirstSubmitQcDate': '2022-05-22', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recruitment rate - descriptive', 'timeFrame': 'immediately after the intervention', 'description': "reported as the number of participants' consented divide by the number of people that were invited to participate"}, {'measure': 'retention rates - descriptive', 'timeFrame': 'immediately after the intervention', 'description': 'reported as the number of participants completing all study sessions'}, {'measure': 'session duration - descriptive', 'timeFrame': 'immediately after the intervention', 'description': 'reported as the average session time for intervention group or attention group'}], 'secondaryOutcomes': [{'measure': 'physical activity and sedentary behavior - questionnaire', 'timeFrame': 'outcome measure was assessed at baseline and within 7 days from the last study session', 'description': 'measured via Global Physical Activity. physical activity level was calculated based on responses. sedentary behavior was reported as average sitting time per day.'}, {'measure': 'psychosocial distress - questionnaire', 'timeFrame': 'outcome measure was assessed at baseline and within 7 days from the last study session', 'description': 'via Kessler Psychological Distress Scale (K10). score range from 10 to 50 and higher scores reflecting higher psychological distress'}, {'measure': 'sleep - questionnaire', 'timeFrame': 'outcome measure was assessed at baseline and within 7 days from the last study session', 'description': 'via Pittsburgh Sleep Quality Index (PSQI). score ranges from 0 to 21. Poor sleepers have ≥ 5 scores as a cut-off global score'}, {'measure': 'dietary habits - questionnaire', 'timeFrame': 'outcome measure was assessed at baseline and within 7 days from the last study session', 'description': 'via food frequency questionnaire (FFQ). data reported as count'}, {'measure': 'social support - questionnaire', 'timeFrame': 'outcome measure was assessed at baseline and within 7 days from the last study session', 'description': 'via Medical Outcomes Study (MOS) Social Support Survey. This tool contains 19 questions, and higher score indicates more social support'}, {'measure': 'fear of COVID-19 - questionnaire', 'timeFrame': 'outcome measure was assessed at baseline and within 7 days from the last study session', 'description': 'via Fear of COVID-19 Scale (FCV-19S). score ranging from 7 to 35. The higher score indicates a higher fear of COVID-19'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health-Related Behavior']}, 'referencesModule': {'references': [{'pmid': '36611550', 'type': 'DERIVED', 'citation': 'Alothman SA, Alshehri MM, Almasud AA, Aljubairi MS, Alrashed I, Abu Shaphe M, Alghannam AF. Virtual Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility RCT during COVID-19 Pandemic. Healthcare (Basel). 2022 Dec 28;11(1):91. doi: 10.3390/healthcare11010091.'}]}, 'descriptionModule': {'briefSummary': 'in this study to "the investigators aim to improve lifestyle behaviors through behavioral interventions. Participants will be assigned to one of two groups. both groups will be asked to complete online survey before and after a 6 virtual session (twice weekly)', 'detailedDescription': 'Participants were randomly assigned into two groups (motivational interviewing intervention or attention group), using a (1:1) computer-generated randomization program (www.graphpad.com).\n\nmotivational interviewing intervention: Each session contained a different component and topic that included substance abuse, physical activity, healthy sleep, stress management, nutrition and social support. The components in order were randomized for each participant. Interviews were conducted using a video meeting platform (Zoom Video Communications Inc., 2016); with both video and audio function enabled while, participants were giving the choice to refuse video calls should they desire. Alternative session delivery method, such as phone calls were used and documented based on participant request.\n\nattention group: received the same amount of virtual session equivalent to MI form. However, the structure of the sessions consisted of brief advice to promote healthy lifestyle delivered by different therapists. The therapist firmly and clearly discussed general lifestyle health topics and provided educational materials during each session'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* living in Saudi Arabia with stay home advisory\n* speak Arabic\n\nExclusion Criteria:\n\n* confirmed or suspected COVID-19 diagnosis'}, 'identificationModule': {'nctId': 'NCT05392218', 'briefTitle': 'Behavioral Intervention to Promote Healthy Lifestyle Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Princess Nourah Bint Abdulrahman University'}, 'officialTitle': 'Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '20-0142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'motivational interviewing', 'interventionNames': ['Behavioral: motivational interviewing']}, {'type': 'SHAM_COMPARATOR', 'label': 'attention group', 'interventionNames': ['Behavioral: general health education']}], 'interventions': [{'name': 'motivational interviewing', 'type': 'BEHAVIORAL', 'description': 'consisted of six sessions (twice each week) up to 30 minutes of individual sessions. Each session contained a different component and topic that included substance abuse, physical activity, healthy sleep, stress management, nutrition and social support. The components in order were randomized for each participant.', 'armGroupLabels': ['motivational interviewing']}, {'name': 'general health education', 'type': 'BEHAVIORAL', 'description': 'rceived the same amount of virtual session equivalent to MI form. However, the structure of the sessions consisted of brief advice to promote healthy lifestyle delivered by different therapists', 'armGroupLabels': ['attention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11321', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Princess Nourah bint Abdulrahman University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Princess Nourah Bint Abdulrahman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Researcher, Clinical Assistant Professor', 'investigatorFullName': 'Shaima Alothman', 'investigatorAffiliation': 'Princess Nourah Bint Abdulrahman University'}}}}