Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: ThinkMed resource at baseline
* Behavioral: Standard Care Control
* Behavioral: ThinkMed resource (staged)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: ThinkMed resource at baseline<br>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 (n=20) | Behavioral: ThinkMed resource at baseline<br>* 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.<br>|
| Experimental: Group 2: ThinkMed resource (staged)<br>This group of participants will receive the ThinkMed resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian (n=20) | Behavioral: ThinkMed resource (staged)<br>* This group of participants will receive the ThinkMed resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian<br>|
| Placebo Comparator: Group 3: Standard Care (control) group<br>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) (n=20) | Behavioral: Standard Care Control<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mediterranean Diet Score (MDS) at 6 months | Mediterranean dietary intake will be measured by a validated questionnaire | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | RPAQ-Recent Physical Activity Questionnaire | Baseline, 6 months | 
| Anthropometric measurements | Weight and height measurements to calculate BMI | Baseline, 6 months | 
| Muscle Strength | Measured using a grip-strength dynamometer | Baseline, 6 months | 
| Geriatric Depression Scale | Geriatric Depression Scale Questionnaire | Baseline, 6 months | 
| Functional Assessment (1) | Measured by the instrumental activities of daily living scale (IADL) by Lawton and Brody (1969) questionnaire | Baseline, 6 months | 
| 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.) | Baseline, 6 months | 
| Barriers to consuming a Mediterranean Diet questionnaire | Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet | Baseline, 6 months | 
| 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. | Baseline, 6 months | 
| Functional Assessment (2) | Measured by the Bristol activities of daily living scale (Bucks et al. 1996) questionnaire | Baseline, 6 months | 
| 4-day Food Diary | A food diary will be completed to assess compliance with a Mediterranean diet | Baseline, 6 months | 
| Change in Lifestyle questionnaire | A questionnaire to measure change in lifestyle behaviours | Baseline, 6 months | 
| Dietary Quality of Life questionnaire | A questionnaire to measure dietary quality of life | Baseline, 6 months | 
| Mediterranean Diet Knowledge questionnaire | A questionnaire to measure participants Mediterranean diet knowledge | Baseline, 6 months | 
| Rand SF-36 HEALTH SURVEY | A questionnaire to measure participants views and beliefs on health | Baseline, 6 months | 
| Staging Algorithm Questionnaire | A questionnaire to measure participants readiness to change their diet and lifestyle | Baseline, 6 months | 
| Mediterranean Diet self-efficacy questionnaire | A questionnaire to measure participants self-efficacy | Baseline, 6 months | 
| Mediterranean diet tolerance questionnaire | A questionnaire to measure tolerance to a Mediterranean diet | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mediterranean diet, Lifestyle