Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: "ThinkMed" resource (staged)Behavioral: Standard Care ControlBehavioral: "ThinkMed" resource at baseline
- Registration Number
- NCT03265522
- Lead Sponsor
- Queen's University, Belfast
- Brief Summary
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
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:
1. Group 1 will receive the Mediterranean lifestyle education resource on one occasion at baseline
2. Group 2 will receive the Mediterranean lifestyle education resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian
3. 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2: "ThinkMed" resource (staged) "ThinkMed" resource (staged) 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) Group 3: Standard Care (control) group Standard Care Control 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) Group 1: "ThinkMed" resource at baseline "ThinkMed" resource at baseline 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)
- 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
- Secondary Outcome Measures
Name Time Method Muscle Strength Baseline, 6 months Measured using a grip-strength dynamometer
Geriatric Depression Scale Baseline, 6 months Geriatric Depression Scale Questionnaire
Barriers to consuming a Mediterranean Diet questionnaire Baseline, 6 months Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet
4-day Food Diary Baseline, 6 months A food diary will be completed to assess compliance with a Mediterranean diet
Mediterranean diet tolerance questionnaire Baseline, 6 months A questionnaire to measure tolerance to a Mediterranean diet
Functional Assessment (1) Baseline, 6 months Measured by the instrumental activities of daily living scale (IADL) by Lawton and Brody (1969) questionnaire
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.
Functional Assessment (2) Baseline, 6 months Measured by the Bristol activities of daily living scale (Bucks et al. 1996) questionnaire
Rand SF-36 HEALTH SURVEY Baseline, 6 months A questionnaire to measure participants views and beliefs on health
Physical Activity Baseline, 6 months RPAQ-Recent Physical Activity Questionnaire
Anthropometric measurements Baseline, 6 months Weight and height measurements to calculate BMI
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.)
Change in Lifestyle questionnaire Baseline, 6 months A questionnaire to measure change in lifestyle behaviours
Mediterranean Diet self-efficacy questionnaire Baseline, 6 months A questionnaire to measure participants self-efficacy
Dietary Quality of Life questionnaire Baseline, 6 months A questionnaire to measure dietary quality of life
Mediterranean Diet Knowledge questionnaire Baseline, 6 months A questionnaire to measure participants Mediterranean diet knowledge
Staging Algorithm Questionnaire Baseline, 6 months A questionnaire to measure participants readiness to change their diet and lifestyle
Trial Locations
- Locations (1)
Belfast Health and Social Care Trust
🇬🇧Belfast, United Kingdom