Tailored Mediterranean Lifestyle Education in Participants With Subjective Cognitive Impairment
- Conditions
- Subjective Cognitive Impairment
- Interventions
- Behavioral: ControlBehavioral: "THINK-MED" resource (baseline)Behavioral: "THINK-MED" resource (staged)
- Registration Number
- NCT03569319
- Lead Sponsor
- Queen's University, Belfast
- Brief Summary
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
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:
1. Group 1 will receive the "THINK-MED" Mediterranean Lifestyle Education for Memory resource on one occasion at baseline (n=10)
2. 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)
3. 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3: Control Control Participants will receive the "THINK-MED" resource after their final 6 month study visit (i.e. delayed intervention) (n=10) Group 1: "THINK-MED" resource (baseline) "THINK-MED" resource (baseline) 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) Group 2: "THINK-MED" resource (staged) "THINK-MED" resource (staged) 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)
- Primary Outcome Measures
Name Time Method Change in Mediterranean Diet Score (MDS) at 6 months 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 Outcome Measures
Name Time Method Anthropometric measurements Baseline, 6 months Weight and height measurements to calculate BMI
Geriatric Depression Scale Baseline, 6 months Depressive symptoms will be measured by the Geriatric Depression Scale Questionnaire, with a score greater than 5 indicating depressive symptoms
Functional Assessment (1) 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
Rand Short Form-36 HEALTH SURVEY Baseline, 6 months A questionnaire to measure participants views and beliefs on health
Mediterranean Diet self-efficacy questionnaire Baseline, 6 months A questionnaire to measure participants self-efficacy
Functional Assessment (2) Baseline, 6 months Measured by the Bristol activities of daily living (Bucks et al. 1996) questionnaire
Change in Physical Activity at 6 months Baseline, 6 months Physical activity will be measured by the Recent Physical Activity Questionnaire (RPAQ)
Muscle Strength Baseline, 6 months Measured using a grip-strength dynamometer
Cognitive Assessment 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.)
4 day food diary Baseline, 6 months A food diary will be completed to assess compliance with a Mediterranean diet
Mediterranean Diet Knowledge questionnaire Baseline, 6 months A questionnaire to measure participants Mediterranean diet knowledge
Dietary Quality of Life questionnaire Baseline, 6 months A questionnaire to measure dietary quality of life
Staging Algorithm Questionnaire Baseline, 6 months A questionnaire to measure participants readiness to change their diet and lifestyle
Change in Lifestyle questionnaire Baseline, 6 months A questionnaire to measure change in lifestyle behaviours
Blood Sample 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.
Barriers to consuming a Mediterranean Diet questionnaire Baseline, 6 months Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet
Trial Locations
- Locations (1)
Queen's University
🇬🇧Belfast, United Kingdom