Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Patients With Mild Cognitive Impairment

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: "ThinkMed" resource at baseline; Behavioral: "ThinkMed" resource (staged); Behavioral: Standard Care Control

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).

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Belfast Health and Social Care Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Diagnosis of Mild Cognitive Impairment by their physician
• Mediterranean diet score (MDS) less than or equal to 4 (Estruch et al., 2006)
• Willing to make changes to their diet

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: "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)	Behavioral: "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.
Experimental: Group 2: "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)	Behavioral: "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
Placebo Comparator: Group 3: Standard Care (control) group; 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)	Behavioral: 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).

What is the study measuring?

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	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	RPAQ-Recent Physical Activity Questionnaire	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Queen's University, Belfast
• Collaborators: Wellcome Trust
• Investigators: Principal Investigator: Jayne Woodside, PhD, Queens University Belfast

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Lifestyle; Mediterranean diet
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 16/NI/0105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No