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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: "ThinkMed" resource at baseline | Experimental | 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) |
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| Group 2: "ThinkMed" resource (staged) | Experimental | 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) |
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| Group 3: Standard Care (control) group | Placebo Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | RPAQ-Recent Physical Activity Questionnaire | Baseline, 6 months |
| Anthropometric measurements | Weight and height measurements to calculate BMI |
| Measure | Description | Time Frame |
|---|---|---|
| Process Evaluation (1) - telephone contact evaluation | Determination individual participation and engagement with the intervention by reviewing telephone contact log record and telephone checklist evaluation | up to 3 months post intervention |
| Process Evaluation (2) - study records |
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayne Woodside, PhD | Queens University Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast Health and Social Care Trust | Belfast | BT9 7AB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33390187 | Derived | 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. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| 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). |
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| "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 |
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| 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 |
A review of study records- including attrition rates, reason for dropout |
| up to 3 months post intervention |
| Process Evaluation (3) - structured interviews | Post intervention structured interviews for participant evaluation of the intervention programme and dietary educational materials | up to 3 months post intervention |