Oral rehabilitation coupled with dietary intervention for older patients

ISRCTN ISRCTN66118345
DOI https://doi.org/10.1186/ISRCTN66118345
Secondary identifying numbers HAPAI/2015/GM
Submission date
22/04/2016
Registration date
25/04/2016
Last edited
19/05/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
A poor diet has been shown to be important in patients developing a range of diseases including cancer, heart disease and diabetes. Different factors influence patients’ food choices, including income levels, education and living circumstances. However, dental health can also be important, such as the number of remaining natural teeth. As patients get older and lose their teeth they tend to move towards a softer diet composed of foods they find easier to chew. Unfortunately this often means that many patients avoid important things such as fruit, vegetables and meat, which can lead to low levels of vitamins, minerals and fibre in their diets. Unfortunately, simply giving patients new teeth or dentures is not enough for them to break these habits and change their diet. This study aims to test if providing tailored diet advice focused on creating healthy eating habits, in combination with replacing missing teeth, can have a positive impact on the diets of older patients.

Who can participate?
Patients over the age of 65 with at least six natural teeth in at least one jaw, with missing natural teeth replaced with removable partial dentures or fixed prosthodontics.

What does the study involve?
All participants receive dental treatment to replace their missing natural teeth. Half of the participants are then randomly allocated to receive the healthy habits diet advice to help them improve their diet, whilst the remainder receive an information leaflet on healthy diets. All participants are asked to fill in surveys asking them about their eating habits, knowledge of nutrition, their satisfaction with food, their physical activity, their quality of life and their oral
health, and they repeat these four times: at the start of the study, after 2 months, 4 months and after 8 months. They are also asked to record their food choices during the study using food diaries. In addition, blood samples are taken during the study to measure levels of a variety of vitamins and nutrients. The information from the two groups is compared to test if the healthy habits dietary advice and counselling has resulted in any improvements for that patient group compared to those who did not receive the healthy habits intervention.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Queen's University Belfast (UK)

When is the study starting and how long is it expected to run for?
October 2016 to March 2017

Who is funding the study?
1. Health Services Executive
2. Public Health Agency Northern Ireland

Who is the main contact?
Dr Gerald McKenna

Contact information

Dr Gerald McKenna
Scientific

Centre for Public Health
Queen's University Belfast
Belfast
BT12 6BA
United Kingdom

Study information

Study designSingle-centre randomised controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe impact of a tailored dietary intervention coupled with oral rehabilitation on the nutritional status of older patients
Study acronymDEN-HAB
Study objectivesTo develop and pilot-test a habit-based tailored dietary intervention, in conjunction with oral rehabilitation, and to examine its impact on positive dietary habit-formation amongst partially dentate older adults.
Ethics approval(s)Office for Research Ethics Committees Northern Ireland (ORECNI), 08/11/2016, ref. 16/NI/0224
Health condition(s) or problem(s) studiedNutrition
InterventionPatients will be randomly allocated to:
1. Intervention: a habit-based dietary intervention suitable for partially dentate older patients
2. Control: no intervention
Intervention typeBehavioural
Primary outcome measureSelf-reported automaticity for healthy food choices (habit-formation indicator) measured using 4-item Self-Report Habit Index (SRHI) on a scale of 1-7
Secondary outcome measures1. Consumption of fruit and vegetables, wholegrains and proteins using validated food diaries
2. Food-related well-being using the validated self-report satisfaction with food-related life scale
3. Knowledge of diet-disease relationships and food preparation abilities (from validated General nutrition knowledge questionnaire [Parmenter & Wardle, 1999]; cooking and food abilities [McGowan et al. in press])
4. Oral health-related Quality of Life using the validated short -form Oral Health Impact profile
5. Markers of nutritional status including haematological analysis of carotenoids, vitamin C, alkylresorcinols and iron, vitamin B12 and folate and the Mini Nutritional Assessment (MNA)
Overall study start date20/04/2016
Completion date23/07/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Total final enrolment54
Key inclusion criteriaCurrent inclusion criteria as of 18/03/2020::
1. A minimum of six natural teeth in at least one jaw with missing natural teeth replaced with removable partial dentures or fixed prosthodontics
2. Patients over the age of 65 years
3. No medical complications which contraindicate routine dental treatment (e.g., unstable cngina; INR level> 4; high risk of infective endocarditis)
4. No evidence of dementia
5. Able to communicate in English
6. Sufficient level of literacy to read study materials and keep a food diary
7. No evidence of diabetes mellitus (Type 1, or Type 2)
8. No history of alcoholism
9. Free-living participant
10. No active treatment for psychiatric disorders
11. Did not follow a strict diet regime recommended by a physician in the prevention or treatment of disease

Previous inclusion criteria:
1. A minimum of six natural teeth in at least one jaw with missing natural teeth replaced with removable partial dentures or fixed prosthodontics
2. Patients over the age of 65 years
3. No medical complications which contraindicate routine dental treatment (e.g., unstable Angina; INR level> 4; high risk of Infective Endocarditis)
4. No evidence of Dementia
5. Able to communicate in English
6. Sufficient level of literacy to read study materials and keep a food diary
Key exclusion criteriaCurrent exclusion criteria as of 18/03/2020::
1. Less than six natural teeth in at least one jaw
2. Patients under the age of 65 years
3. Medical complications which contraindicate routine dental treatment (e.g., unstable Angina; INR level> 4; high risk of infective endocarditis)
4. Evidence of dementia
5. Inability to communicate in English
6. Insufficient level of literacy to read study materials and keep a food diary
7. Evidence of diabetes mellitus (Type 1, or Type 2)
8. History of alcoholism
9. Not a free-living participant
10. Active treatment for psychiatric disorders
11. Followed a strict diet regime recommended by a physician in the prevention or treatment of disease

Previous exclusion criteria:
1. Less than six natural teeth in at least one jaw
2. Patients under the age of 65 years
3. Medical complications which contraindicate routine dental treatment (e.g., unstable Angina; INR level> 4; high risk of Infective Endocarditis)
4. Evidence of Dementia
5. Inability to communicate in English
6. Insufficient level of literacy to read study materials and keep a food diary
Date of first enrolment01/10/2016
Date of final enrolment30/03/2017

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Queen's University Belfast
Centre for Public Health
BT12 6BA
United Kingdom

Sponsor information

Queen's University Belfast (UK)
University/education

University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom

Website http://www.qub.ac.uk/home/Research/
ROR logo "ROR" https://ror.org/00hswnk62

Funders

Funder type

Government

Health Services Executive

No information available

Public Health Agency Northern Ireland

No information available

Results and Publications

Intention to publish date30/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planCurrent publication and dissemination plan as of 18/03/2020:
In 2020 we plan to publish the following publications in a high-impact peer-reviewed journal:
1. Development and feasibility of A Tailored Habit-based Dietary Intervention Coupled With Oral Rehabilitation On The Nutritional Status Of Older Patients
2. The impact of a tailored habit-based dietary intervention coupled with oral rehabilitation on the nutritional status of older patients
3. The impact of a tailored habit-based dietary intervention coupled with oral rehabilitation on the nutritional status of older patients: a process evaluation

Previous publication and dissemination plan as of 28/08/2018:
In 2018 we plan to publish the following publications in a high-impact peer-reviewed journal:
1. The impact of dental status on perceived ability to eat certain foods, nutrient intake and nutritional status in older adults: UK National Diet and Nutrition Survey 2008-2014 (01/03/2019)
2. Barriers and facilitators to healthy eating in community-dwelling older adults: A qualitative study (01/03/2019)
3. The impact of a tailored habit-based dietary intervention coupled with oral rehabilitation on the nutritional status of older patients: A pilot study (01/05/2019)
4. The impact of oral rehabilitation coupled with healthy dietary advice on the nutritional status of adults: a systematic review (01/04/2019)

Previous publication and dissemination plan:
In 2018 we plan to publish the following publications in a high-impact peer-reviewed journal:
1. The impact of dental status on perceived ability to eat certain foods, nutrient intake and nutritional status in older adults: UK National Diet and Nutrition Survey 2008-2014 (30/08/2018)
2. Barriers and facilitators to healthy eating in community-dwelling older adults: A qualitative study (01/03/2019)
3. The impact of a tailored habit-based dietary intervention coupled with oral rehabilitation on the nutritional status of older patients: A pilot study (30/10/2018)
4. The impact of oral rehabilitation coupled with healthy dietary advice on the nutritional status of adults: a systematic review (15/09/2018)
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications feasibility paper 24/08/2020 02/09/2020 Yes No
Results article 01/02/2023 19/05/2023 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

19/05/2023: Publication reference and total final enrolment added.
02/09/2020: Publication reference added.
18/03/2020: The following changes have been made:
1. The overall trial end date has been changed from 01/03/2019 to 23/07/2019.
2. The participant inclusion criteria have been changed.
3. The participant exclusion criteria have been changed.
4. The plain English summary has been updated to add more detail to the 'What does the study involve?' section.
5. The publication and dissemination plan has been changed.
6. The intention to publish date has been changed from 30/08/2018 to 30/12/2020.
29/08/2018: Ethics approval added
28/08/2018: the publication and dissemination plan was updated
23/08/2018: The following changes were made to the trial record:
1. The publication and dissemination plan was added
2. The intention to publish date was updated from 30/06/2018 to the 30/08/2018
3. The participant level data was changed from "not provided at time of registration" to "to be made available at a later date"
17/08/2018: The overall trial end date was updated from 30/06/2017 to 01/03/2019 and the trial acronym "DEN-HAB" was added.
18/10/2017: Internal review.