Tailored Mediterranean Lifestyle Education in Participants With Subjective Cognitive Impairment

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Subjective Cognitive Impairment

Intervention / Treatment
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* Behavioral: THINK-MED resource (baseline)
* Behavioral: THINK-MED resource (staged)
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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
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: THINK-MED resource (baseline)<br>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 (n=10) | Behavioral: THINK-MED resource (baseline)<br>* 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.<br>|
| Experimental: Group 2: THINK-MED resource (staged)<br>This 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) | Behavioral: THINK-MED resource (staged)<br>* This group of participants will receive the THINK-MED resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian<br>|
| Placebo Comparator: Group 3: Control<br>Participants will receive the THINK-MED resource after their final 6 month study visit (i.e. delayed intervention) (n=10) | Behavioral: Control<br>* Participants will receive the THINK-MED 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 with a increase in score by greater than or equal to 3 points at 6 months indicating adoption (maximum score 14) | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity at 6 months | Physical activity will be measured by the Recent Physical Activity Questionnaire (RPAQ) | 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 | Depressive symptoms will be measured by the Geriatric Depression Scale Questionnaire, with a score greater than 5 indicating depressive symptoms | Baseline, 6 months | 
| 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 | Baseline, 6 months | 
| Functional Assessment (2) | Measured by the Bristol activities of daily living (Bucks et al. 1996) 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 | 
| 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 Short Form-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 | 
| 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 | 

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