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NCT Number: NCT03265522

Tailored Mediterranean Lifestyle Education 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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belfast Health and Social Care Trust

Belfast, BT9 7AB, United Kingdom

About this study

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:

  • Group 1 will receive the Mediterranean lifestyle education resource on one occasion at baseline
  • Group 2 will receive the Mediterranean lifestyle education resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

"ThinkMed" resource at baseline

Behavioral

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 Control

Behavioral

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)

Behavioral

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

Primary outcomes

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

    Time frame: Baseline, 6 months

    Mediterranean dietary intake will be measured by a validated questionnaire

Secondary outcomes

  1. Physical Activity

    Time frame: Baseline, 6 months

    RPAQ-Recent Physical Activity Questionnaire

  2. Anthropometric measurements

    Time frame: Baseline, 6 months

    Weight and height measurements to calculate BMI

  3. Muscle Strength

    Time frame: Baseline, 6 months

    Measured using a grip-strength dynamometer

  4. Geriatric Depression Scale

    Time frame: Baseline, 6 months

    Geriatric Depression Scale Questionnaire

  5. Functional Assessment (1)

    Time frame: Baseline, 6 months

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

  6. Cognitive Assessment

    Time frame: Baseline, 6 months

    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.)

  7. Barriers to consuming a Mediterranean Diet questionnaire

    Time frame: Baseline, 6 months

    Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet

  8. Blood Sample

    Time frame: Baseline, 6 months

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

  9. Functional Assessment (2)

    Time frame: Baseline, 6 months

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

  10. 4-day Food Diary

    Time frame: Baseline, 6 months

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

  11. Change in Lifestyle questionnaire

    Time frame: Baseline, 6 months

    A questionnaire to measure change in lifestyle behaviours

  12. Dietary Quality of Life questionnaire

    Time frame: Baseline, 6 months

    A questionnaire to measure dietary quality of life

  13. Mediterranean Diet Knowledge questionnaire

    Time frame: Baseline, 6 months

    A questionnaire to measure participants Mediterranean diet knowledge

  14. Rand SF-36 HEALTH SURVEY

    Time frame: Baseline, 6 months

    A questionnaire to measure participants views and beliefs on health

  15. Staging Algorithm Questionnaire

    Time frame: Baseline, 6 months

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

  16. Mediterranean Diet self-efficacy questionnaire

    Time frame: Baseline, 6 months

    A questionnaire to measure participants self-efficacy

  17. Mediterranean diet tolerance questionnaire

    Time frame: Baseline, 6 months

    A questionnaire to measure tolerance to a Mediterranean diet

Other outcomes

  1. Process Evaluation (1) - telephone contact evaluation

    Time frame: up to 3 months post intervention

    Determination individual participation and engagement with the intervention by reviewing telephone contact log record and telephone checklist evaluation

  2. Process Evaluation (2) - study records

    Time frame: up to 3 months post intervention

    A review of study records- including attrition rates, reason for dropout

  3. Process Evaluation (3) - structured interviews

    Time frame: up to 3 months post intervention

    Post intervention structured interviews for participant evaluation of the intervention programme and dietary educational materials

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Wellcome Trust

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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