Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT04946292
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2021-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowering Older Adults for Healthy Living and Better Dental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increment of coronal caries', 'timeFrame': 'From baseline to 2 years post-intervention', 'description': 'Number of new surfaces with coronal caries'}, {'measure': 'Increment of root caries', 'timeFrame': 'From baseline to 2 years post-intervention', 'description': 'Number of new surfaces with root caries'}], 'secondaryOutcomes': [{'measure': 'Change in dietary behaviours (favourable/unfavourable)', 'timeFrame': 'From baseline to 2 years post-intervention', 'description': 'Using a questionnaire, dietary behaviours will be categorised into:\n\n1. favourable (frequency of snack intake, sweet/desert intake and/or sugary drinks \\<2times/day)\n2. unfavourable (frequency of snack intake, sweet/desert intake and/or sugary drinks \\>=2times/day)'}, {'measure': 'Change in toothbrushing behaviours (favourable/unfavourable)', 'timeFrame': 'From baseline to 2 years post-intervention', 'description': 'Using a questionnaire, toothbrushing behaviours will be categorised as:\n\n1. favourable (frequency of brushing \\>=2times/day)\n2. unfavourable (frequency of brushing \\<2times/day)'}, {'measure': 'Change in flossing behaviours (favourable/unfavourable)', 'timeFrame': 'From baseline to 2 years post-intervention', 'description': 'Using questionnaire to evaluate frequency of flossing (with \\>=once/day considered as favourable and \\<once/day considered unfavourable)'}, {'measure': 'Change in oral hygiene status (plaque score)', 'timeFrame': 'From baseline to 2 years post-intervention', 'description': 'Presence or absence of dental plaque on tooth surfaces'}, {'measure': 'Change in periodontal condition', 'timeFrame': 'From baseline to 2 years post-intervention', 'description': 'Number of sites with deep periodontal pockets, shallow periodontal pockets, and gingival bleeding only'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral health', 'health behaviours', 'periodontal disease', 'theory-derived intervention'], 'conditions': ['Periodontal Diseases', 'Dental Caries']}, 'referencesModule': {'references': [{'pmid': '36523250', 'type': 'DERIVED', 'citation': 'Gao X, Wong ML, Kalhan AC, Xie JJ, Siti Hajar H, Yeo ABK, Allen PF. Theory-derived intervention to improve oral health of older adults: study protocol for a randomised controlled trial. BMJ Open. 2022 Dec 12;12(12):e064791. doi: 10.1136/bmjopen-2022-064791.'}]}, 'descriptionModule': {'briefSummary': "Ageing of the world's population is accelerating. Despite the health challenges they face, older people should not be stereotyped as frail and dependent. Healthy ageing is possible if adequate care is provided and effective intervention is delivered for healthy living. Common oral diseases (dental caries and periodontal diseases) are determined to a great extent by health behaviours (diet and oral hygiene) and are controllable through effective interventions. Hence, this study aims to test the theoretical models for health promotion, develop theory-derived intervention, and evaluate its effectiveness in improving oral health of older adults. The study hypothesis is that theory-derived intervention is more effective than conventional health education in eliciting positive behaviours and controlling oral diseases in older adults.", 'detailedDescription': 'This study targets older adults and aims to (i) test the explanatory power of the dominant theoretical models/ frameworks, (ii) develop theory-derived intervention, and (iii) evaluate the effectiveness of the theory-derived intervention. The hypothesis is that theoretical-derived intervention is more effective than conventional health education in improving oral health behaviours and preventing oral diseases among older adults.\n\nThe sample size needed for this study was calculated by using the software G\\*Power version 3.1.9.2 (Franz Faul, University of Kiel, Germany). The sample size calculation was based on the primary outcomes, namely increment of coronal caries and increment of root caries, and independent t-tests for comparing means of two independent groups. A caries incidence study among the elderly reported that the mean (SD) 5-year caries incidence were 2.65 (3.14) for coronal caries and 2.21 (2.83) for root caries 17. The 2-year incidence of coronal caries and root caries were therefore estimated to be 1.06 (1.26) and 0.88 (1.13), respectively, in the control group. The effect of an intervention is considered clinically significant if it reduces the caries incidence by 40%. Based on a significance level of 5% and a power of 80%, 140 subjects per group are needed for coronal caries and 165 subjects are needed for root caries outcome measures. To take both outcome measures into account, the higher number (i.e., n=165) will be adopted. Allowing for a 25% attrition rate, 220 elderly persons will need to be recruited into each group, giving a total sample size of 440.\n\nEach participant will be required to complete a detailed questionnaire at the initial visit through face-to-face interviews. Information on socio-demographic background (gender, age, education level, past occupation, and type of housing) and oral health behaviours (diet, toothbrushing and dental flossing) will be collected. The questionnaire will also include the scales for three dominant theoretical models, namely, Health Belief Model (HBM), Theory of planned behaviour (TPB) and Social Cognitive Theory (SCT).\n\nThe theoretical model that best explains the health behaviours will be selected for designing oral health intervention. Intervention materials and activities will be carefully designed to address all the constructs/ domains of the selected theoretical model(s). Relevant medical literatures will be referred to. The needs, interest, and health literary of the target group (i.e. older adults of varied social and educational backgrounds) will be taken into full consideration. The intervention will be tested in a small group of 15-20 older people to ensure its relevance, practicality, and acceptability.\n\nParticipants will be randomly assigned to two groups, stratified by gender and education level. Allocation concealment will be ensured by using sealed opaque envelopes. The two groups will receive conventional health education and theory-derived intervention, respectively.\n\nAt baseline and 6-, 12-, and 24-months post-intervention, each participant will a) undergo an oral examination (dental checkup) by a trained dentist, who will be calibrated against an experienced oral epidemiologist and blinded to the group allocation, and b) complete a questionnaire (detailed questionnaire at baseline and short questionnaire for follow-ups). Chi-square tests will be used for comparing proportions. Parametric or non-parametric methods will be adopted for comparing means. ANCOVA (analysis of covariance) and multiple regressions will be performed to evaluate the effects of various factors on the outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 55-70 years old\n* Living in the community (alone or with family members), instead of residing in a nursing home\n* Having at least 8 natural teeth\n* No plan to immigrate in 3 years\n\nExclusion Criteria:\n\n• Life-threatening disease; impaired cognitive function (e.g. Alzheimer's syndrome); radiotherapy in the head and neck region"}, 'identificationModule': {'nctId': 'NCT04946292', 'briefTitle': 'Empowering Older Adults for Healthy Living and Better Dental Health', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'Developing and Evaluating a Theory-derived Intervention to Improve Oral Health of Community-dwelling Elderly', 'orgStudyIdInfo': {'id': 'R-221-000-140-133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theory-derived intervention', 'description': 'Questionnaire will be used including the scales for three dominant theoretical models, Health Belief Model (HBM), Theory of planned behaviour (TPB) and Social Cognitive Theory (SCT). The theoretical model that best explains the health behaviours of the selected participants will be selected for designing oral health intervention.The theory-derived intervention will address the constructs/domains of the selected model(s) in the context of the three target behaviours (diet, toothbrushing and dental flossing).', 'interventionNames': ['Behavioral: Theory-derived intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional health education', 'description': 'Participants will be randomly assigned to the control group, stratified by gender and education level. Allocation concealment will be ensured by using sealed opaque envelopes.', 'interventionNames': ['Behavioral: Conventional health education']}], 'interventions': [{'name': 'Theory-derived intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention will be delivered through multimedia materials and group activities, as appropriate. Participants will spend approximately 30-45 minutes for the intervention. Intervention materials and activities will be carefully designed to address all the constructs/ domains of the selected theoretical model(s). The effectiveness of the interventions will be evaluated using behavioural outcomes (diet, brushing, flossing) and clinical outcomes (oral hygiene, caries and periodontal conditions).', 'armGroupLabels': ['Theory-derived intervention']}, {'name': 'Conventional health education', 'type': 'BEHAVIORAL', 'description': 'The conventional health education will be delivered through an oral health talk and oral health booklet. Topics covered are: (i) common oral diseases and its consequences; (ii) common dental problems among older adults; (iii) importance of oral health measures (healthy diet, toothbrushing and dental flossing); and (iv) proper techniques for toothbrushing and dental flossing.', 'armGroupLabels': ['Conventional health education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119085', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Xiaoli Gao', 'role': 'CONTACT', 'email': 'dengx@nus.edu.sg', 'phone': '67724990'}], 'facility': 'Faculty of Dentistry, National University of Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Gao Xiaoli, PhD', 'role': 'CONTACT', 'email': 'dengx@nus.edu.sg', 'phone': '(65) 67724990'}], 'overallOfficials': [{'name': 'Gao Xiaoli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, National University of Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gao Xiaoli', 'investigatorAffiliation': 'National University of Singapore'}}}}