Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/04/2016
Date assigned
25/04/2016
Last edited
22/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 knowledge of nutrition, their satisfaction with food and their oral health, and they repeat these three times: at the start of the study, after two months and after six months. They are also asked to record their food choices during the study using food diaries and surveys. 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

Contact information

Type

Scientific

Primary contact

Dr Gerald McKenna

ORCID ID

Contact details

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

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

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) – submission pending

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 measures

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

30/06/2017

Reason abandoned

Eligibility

Participant 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

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

http://www.qub.ac.uk/home/Research/

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

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes