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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: "THINK-MED" resource (baseline) | Experimental | 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) |
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| Group 2: "THINK-MED" resource (staged) | Experimental | 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) |
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| Group 3: Control | Placebo Comparator | Participants will receive the "THINK-MED" resource after their final 6 month study visit (i.e. delayed intervention) (n=10) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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. |
| 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 |
| 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 |
| 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 | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University | Belfast | 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 |
|---|---|
| C074807 | BaseLine dental cement |
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| "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). |
|
| 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 |
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 |