Empowering Older Adults for Healthy Living and Better Dental Health

Developing and Evaluating a Theory-derived Intervention to Improve Oral Health of Community-dwelling Elderly

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases; Dental Caries
• Intervention / Treatment: Behavioral: Theory-derived intervention; Behavioral: Conventional health education

Detailed Description

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.

The 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.

Each 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).

The 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.

Participants 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.

At 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.

• Study Type: Interventional
• Enrollment (Anticipated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gao Xiaoli, PhD; Phone Number: (65) 67724990; Email: dengx@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119085
    • Recruiting
    • Faculty of Dentistry, National University of Singapore
    • Contact: Xiaoli Gao; Phone Number: 67724990; Email: dengx@nus.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 55-70 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Theory-derived intervention; 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; 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).
Active Comparator: Conventional health education; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dietary behaviours (favourable/unfavourable)	Using a questionnaire, dietary behaviours will be categorised into: favourable (frequency of snack intake, sweet/desert intake and/or sugary drinks <2times/day); unfavourable (frequency of snack intake, sweet/desert intake and/or sugary drinks >=2times/day)	From baseline to 2 years post-intervention
Change in flossing behaviours (favourable/unfavourable)	Using questionnaire to evaluate frequency of flossing (with >=once/day considered as favourable and <once/day considered unfavourable)	From baseline to 2 years post-intervention
Change in toothbrushing behaviours (favourable/unfavourable)	Using a questionnaire, toothbrushing behaviours will be categorised as: favourable (frequency of brushing >=2times/day); unfavourable (frequency of brushing <2times/day)	From baseline to 2 years post-intervention
Change in oral hygiene status (plaque score)	Presence or absence of dental plaque on tooth surfaces	From baseline to 2 years post-intervention
Change in periodontal condition	Number of sites with deep periodontal pockets, shallow periodontal pockets, and gingival bleeding only	From baseline to 2 years post-intervention

Collaborators and Investigators

• Sponsor: National University of Singapore
• Investigators: Principal Investigator: Gao Xiaoli, PhD, Faculty of Dentistry, National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: periodontal disease; oral health; health behaviours; theory-derived intervention
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Periodontal Diseases
• Other Study ID Numbers: R-221-000-140-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No