Empowering Older Adults for Healthy Living and Better Dental Health

Sponsor
National University, Singapore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04946292
Collaborator
(none)
440
1
2
26.1
16.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Theory-derived intervention
  • Behavioral: Conventional health education
N/A

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 primary outcomes are number of carious surfaces and number of sites with bleeding on probing or periodontal pockets. Since both outcomes are continuous variables, the sample size calculation was based on independent t-tests for comparing means of two independent groups. An effect size of 0.3 is considered clinically significant. Based on a significance level of 0.05 and a power of 0.80, 176 subjects per group are needed. Allowing for a 20% attrition rate, 220 participants 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 Design

Study Type:
Interventional
Anticipated Enrollment :
440 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Health Services Research
Official Title:
Developing and Evaluating a Theory-derived Intervention to Improve Oral Health of Community-dwelling Elderly
Actual Study Start Date :
Mar 29, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in dietary behaviours (favourable/unfavourable) [From baseline to 2 years post-intervention]

    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)

  2. Change in toothbrushing behaviours (favourable/unfavourable) [From baseline to 2 years post-intervention]

    Using a questionnaire, toothbrushing behaviours will be categorised as: favourable (frequency of brushing >=2times/day and brushing time >=2 minutes) unfavourable (frequency of brushing <2times/day and brushing time < 2 minutes)

  3. Change in flossing behaviours (favourable/unfavourable) [From baseline to 2 years post-intervention]

    Using questionnaire to evaluate frequency of flossing (with >=once/day considered as favourable and <once/day considered unfavourable)

  4. Change in dental caries status (No change/increase in lesions) [From baseline to 2 years post-intervention]

    Decayed, missing, filled teeth (DMFT index)

  5. Change in oral hygiene (Good/Fair/Poor) [From baseline to 2 years post-intervention]

    Presence or absence of dental plaque

  6. Change in pocket depth (PD) in mm [From baseline to 2 years post-intervention]

    Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin

  7. Change in bleeding on probing (BOP index) [From baseline to 2 years post-intervention]

    presence or absence of bleeding within 10 seconds after probing.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, National University of Singapore Singapore Singapore 119085

Sponsors and Collaborators

  • National University, Singapore

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gao Xiaoli, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier:
NCT04946292
Other Study ID Numbers:
  • R-221-000-140-133
First Posted:
Jun 30, 2021
Last Update Posted:
May 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gao Xiaoli, Associate Professor, National University, Singapore
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2022