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Mild Cognitive ImpairmentNCT03265522

Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

A study testing "ThinkMed" resource at baseline and "ThinkMed" resource (staged) in people with Mild Cognitive Impairment, run by Queen's University, Belfast at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evidence suggests that a Mediterranean diet can have a beneficial effect on brain health. Mild cognitive impairment (MCI) describes problems with brain function such as difficulty with day-to-day memory and concentration. It is at this stage that Mediterranean diet could prove beneficial in terms of prevention. Read more about this study

Who is it for?
Any age
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
"ThinkMed" resource at baseline and "ThinkMed" resource (staged)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2017to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of Mild Cognitive Impairment by their physician
  • Mediterranean diet score (MDS) less than or equal to 4 (Estruch et al., 2006)
  • Willing to make changes to their diet

Who cannot join

  • Diagnosis of dementia
  • Patients with visual or English language impairment
  • Psychiatric problems
  • Significant medical comorbidity
  • Body Mass Index (BMI) ≤ 19 and ≥ 40 kg/m2
  • Excessive alcohol consumption
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  • Taking high dose nutritional supplements
  • Dietary restrictions/allergies that would substantially limit ability to complete study requirements
  • Inability to provide informed consent
  • History of, or comorbid condition which may alter performance on cognitive tests e.g. stroke, head injury, Parkinson's disease, learning disability

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Belfast Health and Social Care Trust

    Belfast, BT9 7AB

Other trials in United Kingdom

About this study

Official title: The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Patients With Mild Cognitive Impairment

Evidence suggests that a Mediterranean diet can have a beneficial effect on brain health. Mild cognitive impairment (MCI) describes problems with brain function such as difficulty with day-to-day memory and concentration. It is at this stage that Mediterranean diet could prove beneficial in terms of prevention.

Previous research by Queens University investigated the opinions of patients with MCI and their care givers to inform the development of Mediterranean diet education material to encourage behaviour change. The study suggested that MCI patients lacked awareness of the link between Mediterranean diet and brain function, although were interested to learn more. Feedback on the developed educational material was positive although there were suggested improvements such as tailoring information to memory loss, a potential staged approach to delivery and adaptations to the material content.

This present study aims to pilot test refined educational material among MCI participants to evaluate the feasibility of encouraging dietary behaviour change among this patient group.

Read the detailed description

This study aims to evaluate the feasibility of a theory-based, tailored Mediterranean lifestyle education intervention to encourage behaviour change in patients with MCI. The proposed study will be a 6 month RCT with a total of 60 MCI patients who will be randomised to 1 of 3 groups:

  1. Group 1 will receive the Mediterranean lifestyle education resource on one occasion at baseline
  2. Group 2 will receive the Mediterranean lifestyle education resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian
  3. Group 3 will receive standard care (control group). Participants will receive the Mediterranean lifestyle education resource after their final 6 month study visit (i.e. delayed intervention).
Being tested
"ThinkMed" resource at baseline, Standard Care Control, "ThinkMed" resource (staged)
Keywords
Mediterranean diet, Lifestyle
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "ThinkMed" resource at baselineBehavioural

    The "ThinkMed" resource contains an information booklet, recipe books, menu plan cards, shopping list cards and goal setting cards. Participants will receive this resource on one occasion at baseline.

  • Standard Care ControlBehavioural

    Participants will continue with the standard care provided by their physician. Participants will receive the "ThinkMed" resource after their final 6 month study visit (i.e. delayed intervention).

  • "ThinkMed" resource (staged)Behavioural

    This group of participants will receive the "ThinkMed" resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian

Study groups in NCT03265522
Study groupRoleWhat they receive
Group 1: "ThinkMed" resource at baselineExperimentalThe "ThinkMed" resource contains an information booklet, recipe books, menu plan cards, shopping list cards and goal setting cards. Participants will receive this resource on one occasion at baseline (n=20)
Receives: Behavioral: "ThinkMed" resource at baseline
Group 2: "ThinkMed" resource (staged)ExperimentalThis group of participants will receive the "ThinkMed" resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian (n=20)
Receives: Behavioral: "ThinkMed" resource (staged)
Group 3: Standard Care (control) groupPlacebo comparatorParticipants will continue with the standard care provided by their physician. Participants will receive the "ThinkMed" resource after their final 6 month study visit (i.e. delayed intervention) (n=20)
Receives: Behavioral: Standard Care Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mediterranean Diet Score (MDS) at 6 months

    Mediterranean dietary intake will be measured by a validated questionnaire

    Measured: Baseline, 6 months

Secondary outcomes (17)

  1. Physical Activity

    RPAQ-Recent Physical Activity Questionnaire

    Measured: Baseline, 6 months

  2. Anthropometric measurements

    Weight and height measurements to calculate BMI

    Measured: Baseline, 6 months

  3. Muscle Strength

    Measured using a grip-strength dynamometer

    Measured: Baseline, 6 months

  4. Geriatric Depression Scale

    Geriatric Depression Scale Questionnaire

    Measured: Baseline, 6 months

  5. Functional Assessment (1)

    Measured by the instrumental activities of daily living scale (IADL) by Lawton and Brody (1969) questionnaire

    Measured: Baseline, 6 months

  6. Cognitive Assessment

    A comprehensive cognitive assessment will be performed, including: global cognition, motor skills, executive function episodic/visual memory, and information processing and sustained attention using a validated neuropsychological test battery (Cantab Cognitive Battery, Cambridge Cognition Ltd.)

    Measured: Baseline, 6 months

  7. Barriers to consuming a Mediterranean Diet questionnaire

    Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet

    Measured: Baseline, 6 months

  8. Blood Sample

    A blood sample will be taken from participants to be stored for analysis of biomarkers of MD adherence and biomarkers of neurodegenerative disease risk.

    Measured: Baseline, 6 months

  9. Functional Assessment (2)

    Measured by the Bristol activities of daily living scale (Bucks et al. 1996) questionnaire

    Measured: Baseline, 6 months

  10. 4-day Food Diary

    A food diary will be completed to assess compliance with a Mediterranean diet

    Measured: Baseline, 6 months

  11. Change in Lifestyle questionnaire

    A questionnaire to measure change in lifestyle behaviours

    Measured: Baseline, 6 months

  12. Dietary Quality of Life questionnaire

    A questionnaire to measure dietary quality of life

    Measured: Baseline, 6 months

  13. Mediterranean Diet Knowledge questionnaire

    A questionnaire to measure participants Mediterranean diet knowledge

    Measured: Baseline, 6 months

  14. Rand SF-36 HEALTH SURVEY

    A questionnaire to measure participants views and beliefs on health

    Measured: Baseline, 6 months

  15. Staging Algorithm Questionnaire

    A questionnaire to measure participants readiness to change their diet and lifestyle

    Measured: Baseline, 6 months

  16. Mediterranean Diet self-efficacy questionnaire

    A questionnaire to measure participants self-efficacy

    Measured: Baseline, 6 months

  17. Mediterranean diet tolerance questionnaire

    A questionnaire to measure tolerance to a Mediterranean diet

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start1 May 2017
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03265522
Sponsor's protocol ID
16/NI/0105
Status last verified
Nov 2019
First submitted
23 Aug 2017
Last updated
4 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • McGrattan AM, McEvoy CT, Vijayakumar A, Moore SE, Neville CE, McGuinness B, McKinley MC, Woodside JV. A mixed methods pilot randomised controlled trial to develop and evaluate the feasibility of a Mediterranean diet and lifestyle education intervention 'THINK-MED' among people with cognitive impairment. Pilot Feasibility Stud. 2021 Jan 4;7(1):3. doi: 10.1186/s40814-020-00738-3.

    PubMed 33390187

Questions about this trial

What is this clinical trial studying?

A study testing "ThinkMed" resource at baseline and "ThinkMed" resource (staged) in people with Mild Cognitive Impairment, run by Queen's University, Belfast at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mediterranean Diet Score (MDS) at 6 months (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03265522, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.

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