Empowering Older Adults for Healthy Living and Better Dental Health

NCT04946292 | Unknown

• 1 other identifier: R-221-000-140-133
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases; Dental Caries

Keywords

oral health; health behaviours; periodontal disease; theory-derived intervention

Outcome Measures

Primary Outcomes (2)

• Increment of coronal caries

  Number of new surfaces with coronal caries

  From baseline to 2 years post-intervention

• Increment of root caries

  Number of new surfaces with root caries

  From baseline to 2 years post-intervention

Secondary Outcomes (5)

• Change in dietary behaviours (favourable/unfavourable)

  From baseline to 2 years post-intervention

• Change in toothbrushing behaviours (favourable/unfavourable)

  From baseline to 2 years post-intervention

• Change in flossing behaviours (favourable/unfavourable)

  From baseline to 2 years post-intervention

• Change in oral hygiene status (plaque score)

  From baseline to 2 years post-intervention

• Change in periodontal condition

  From baseline to 2 years post-intervention

Study Arms (2)

Theory-derived intervention

EXPERIMENTAL

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).

Behavioral: Theory-derived intervention

Conventional health education

ACTIVE COMPARATOR

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.

Behavioral: Conventional health education

Interventions

Theory-derived intervention BEHAVIORAL

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).

Theory-derived intervention

Conventional health education BEHAVIORAL

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.

Conventional health education

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Living in the community (alone or with family members), instead of residing in a nursing home
• Having at least 8 natural teeth
• No plan to immigrate in 3 years

You may not qualify if:

• Life-threatening disease; impaired cognitive function (e.g. Alzheimer's syndrome); radiotherapy in the head and neck region

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

Faculty of Dentistry, National University of Singapore

Singapore, 119085, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 36523250 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Dental Caries

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases

Study Officials

• Gao Xiaoli, PhD

  Faculty of Dentistry, National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao Xiaoli, PhD

CONTACT

(65) 67724990; dengx@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 30, 2021
• Study Start: March 29, 2022
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)