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Subjective Cognitive ImpairmentNCT03569319

Tailored Mediterranean Lifestyle Education in Participants With Subjective Cognitive Impairment

A study testing "THINK-MED" resource (baseline) and "THINK-MED" resource (staged) in people with Subjective 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

It is estimated that 30% of Alzheimer's disease cases globally are associated with changeable risk factors, such as diet and physical activity. In particular, a Mediterranean diet (MD) has been associated with reduced risk of cognitive decline and improved brain function. Read more about this study

Who is it for?
Any age
Conditions the study is for
Subjective Cognitive Impairment
What is being tested?
"THINK-MED" resource (baseline) and "THINK-MED" resource (staged)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
1 siteUnited Kingdom
Study dates
18 May 2018to 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

  • Have subjective cognitive impairment - Montreal Cognitive Assessment (MoCA) score ≥ 26/30
  • Mediterranean diet score (MDS) ≤ 4 (Estruch et al. 2006)
  • Willing to make changes to their diet

Who cannot join

  • Diagnosis of dementia
  • MoCA score of ≤ 25/30
  • Individuals with a visual or English language impairment
  • Psychiatric problems e.g. depression
  • Significant medical comorbidity
  • Body Mass Index (BMI) ≤ 19 and ≥ 40 kg/m2
Show all 10Show fewer
  • Excessive alcohol consumption
  • 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

  • Queen's University

    Belfast

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 Participants With Subjective Cognitive Impairment

It is estimated that 30% of Alzheimer's disease cases globally are associated with changeable risk factors, such as diet and physical activity. In particular, a Mediterranean diet (MD) has been associated with reduced risk of cognitive decline and improved brain function.

The investigators developed educational resources on the Mediterranean diet and lifestyle (THINK-MED) in accordance with the Medical Research Council guidance for developing and evaluating complex interventions, based on a systematic literature review and informed by qualitative work with patients with mild memory problems.The feedback gathered informed refinements and tailoring of the resource and overall MD intervention.

This study aims to evaluate feasibility of the "THINK-MED" Mediterranean lifestyle educational intervention to encourage dietary behaviour change among community-dwelling people with subjective cognitive impairment.

Read the detailed description

This pilot RCT aims to evaluate the feasibility of a theory-based, tailored Mediterranean lifestyle education intervention (THINK-MED) to encourage behaviour change among participants who have subjective cognitive impairment.

This study will be a 6 month randomised controlled trial (RCT) with a total of 30 participants who will be randomised to 1 of 3 groups:

  1. Group 1 will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource on one occasion at baseline (n=10)
  2. Group 2 will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource at monthly intervals for 5 months, with an initial face-to-face visit from the research dietitian (month 1) and accompanied by telephone feedback (month 2-5) (n=10)
  3. Group 3 is a control group. Participants in this group will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource after completing the 6 month study (n=10)
Being tested
"THINK-MED" resource (baseline), "THINK-MED" resource (staged), Control
Keywords
Mediterranean Diet, Lifestyle

What participants receive

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

  • "THINK-MED" resource (baseline)Behavioural

    The "THINK-MED" 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.

  • "THINK-MED" resource (staged)Behavioural

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

  • ControlBehavioural

    Participants will receive the "THINK-MED" resource after their final 6 month study visit (i.e. delayed intervention).

Study groups in NCT03569319
Study groupRoleWhat they receive
Group 1: "THINK-MED" resource (baseline)ExperimentalThe "THINK-MED" 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=10)
Receives: Behavioral: "THINK-MED" resource (baseline)
Group 2: "THINK-MED" resource (staged)ExperimentalThis group of participants will receive the "THINK-MED" resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian (n=10)
Receives: Behavioral: "THINK-MED" resource (staged)
Group 3: ControlPlacebo comparatorParticipants will receive the "THINK-MED" resource after their final 6 month study visit (i.e. delayed intervention) (n=10)
Receives: Behavioral: 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 with a increase in score by greater than or equal to 3 points at 6 months indicating adoption (maximum score 14)

    Measured: Baseline, 6 months

Secondary outcomes (16)

  1. Change in Physical Activity at 6 months

    Physical activity will be measured by the Recent Physical Activity Questionnaire (RPAQ)

    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

    Depressive symptoms will be measured by the Geriatric Depression Scale Questionnaire, with a score greater than 5 indicating depressive symptoms

    Measured: Baseline, 6 months

  5. Functional Assessment (1)

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

    Measured: Baseline, 6 months

  6. Functional Assessment (2)

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

    Measured: Baseline, 6 months

  7. 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

  8. 4 day food diary

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

    Measured: Baseline, 6 months

  9. Change in Lifestyle questionnaire

    A questionnaire to measure change in lifestyle behaviours

    Measured: Baseline, 6 months

  10. Dietary Quality of Life questionnaire

    A questionnaire to measure dietary quality of life

    Measured: Baseline, 6 months

  11. Mediterranean Diet Knowledge questionnaire

    A questionnaire to measure participants Mediterranean diet knowledge

    Measured: Baseline, 6 months

  12. Rand Short Form-36 HEALTH SURVEY

    A questionnaire to measure participants views and beliefs on health

    Measured: Baseline, 6 months

  13. Staging Algorithm Questionnaire

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

    Measured: Baseline, 6 months

  14. Mediterranean Diet self-efficacy questionnaire

    A questionnaire to measure participants self-efficacy

    Measured: Baseline, 6 months

  15. Barriers to consuming a Mediterranean Diet questionnaire

    Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet

    Measured: Baseline, 6 months

  16. 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

Timeline

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

  1. First posted26 Jun 2018
  2. Study start18 May 2018
  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
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03569319
Sponsor's protocol ID
18/NI/0077
Status last verified
Apr 2024
First submitted
3 Jun 2018
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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 "THINK-MED" resource (baseline) and "THINK-MED" resource (staged) in people with Subjective 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 3 Apr 2024. 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 NCT03569319, 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 3 Apr 2024.

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