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Completed

NCT Number: NCT03569319

Tailored Mediterranean Lifestyle Education 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.

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Key information

Conditions

Subjective Cognitive Impairment

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University

Belfast, United Kingdom

About this study

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:

  • Group 1 will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource on one occasion at baseline (n=10)
  • 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)
  • 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)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

"THINK-MED" resource (baseline)

Behavioral

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)

Behavioral

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

Control

Behavioral

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

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 with a increase in score by greater than or equal to 3 points at 6 months indicating adoption (maximum score 14)

Secondary outcomes

  1. Change in Physical Activity at 6 months

    Time frame: Baseline, 6 months

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

  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

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

  5. Functional Assessment (1)

    Time frame: Baseline, 6 months

    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

  6. Functional Assessment (2)

    Time frame: Baseline, 6 months

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

  7. 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.)

  8. 4 day food diary

    Time frame: Baseline, 6 months

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

  9. Change in Lifestyle questionnaire

    Time frame: Baseline, 6 months

    A questionnaire to measure change in lifestyle behaviours

  10. Dietary Quality of Life questionnaire

    Time frame: Baseline, 6 months

    A questionnaire to measure dietary quality of life

  11. Mediterranean Diet Knowledge questionnaire

    Time frame: Baseline, 6 months

    A questionnaire to measure participants Mediterranean diet knowledge

  12. Rand Short Form-36 HEALTH SURVEY

    Time frame: Baseline, 6 months

    A questionnaire to measure participants views and beliefs on health

  13. Staging Algorithm Questionnaire

    Time frame: Baseline, 6 months

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

  14. Mediterranean Diet self-efficacy questionnaire

    Time frame: Baseline, 6 months

    A questionnaire to measure participants self-efficacy

  15. Barriers to consuming a Mediterranean Diet questionnaire

    Time frame: Baseline, 6 months

    Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet

  16. 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.

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 Participants With Subjective Cognitive Impairment

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2018
Registry last updated
Apr 3, 2024

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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