Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HAPAI/2015/GM
Study information
Scientific title
The impact of a tailored dietary intervention coupled with oral rehabilitation on the nutritional status of older patients
Acronym
DEN-HAB
Study hypothesis
To 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
Office for Research Ethics Committees Northern Ireland (ORECNI), 08/11/2016, ref. 16/NI/0224
Study design
Single-centre randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Nutrition
Intervention
Patients will be randomly allocated to:
1. Intervention: a habit-based dietary intervention suitable for partially dentate older patients
2. Control: no intervention
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Self-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 measures
1. 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 trial start date
20/04/2016
Overall trial end date
23/07/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
Current 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
Recruitment start date
01/10/2016
Recruitment end date
30/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen's University Belfast
Centre for Public Health
BT12 6BA
United Kingdom
Sponsor information
Organisation
Queen's University Belfast (UK)
Sponsor details
University Road
Belfast
BT7 1NN
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Services Executive
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Public Health Agency Northern Ireland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Current 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 statement: The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
30/12/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2020 feasibility paper in https://pubmed.ncbi.nlm.nih.gov/32855815/ (added 02/09/2020)