Tailored Mediterranean Lifestyle Education in Participants With Subjective Cognitive Impairment

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

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.

Study Overview

• Status: Completed
• Conditions: Subjective Cognitive Impairment
• Intervention / Treatment: Behavioral: "THINK-MED" resource (baseline); Behavioral: "THINK-MED" resource (staged); Behavioral: Control

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)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • Queen's University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 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: "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)	Behavioral: "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.
Experimental: Group 2: "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)	Behavioral: "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
Placebo Comparator: Group 3: Control; Participants will receive the "THINK-MED" resource after their final 6 month study visit (i.e. delayed intervention) (n=10)	Behavioral: Control; Participants will receive the "THINK-MED" 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 with a increase in score by greater than or equal to 3 points at 6 months indicating adoption (maximum score 14)	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measurements	Weight and height measurements to calculate BMI	Baseline, 6 months
Muscle Strength	Measured using a grip-strength dynamometer	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
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
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
Change in Physical Activity at 6 months	Physical activity will be measured by the Recent Physical Activity Questionnaire (RPAQ)	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
4 day food diary	A food diary will be completed to assess compliance with a Mediterranean diet	Baseline, 6 months
Rand Short Form-36 HEALTH SURVEY	A questionnaire to measure participants views and beliefs on health	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, Queen's 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 18, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: June 3, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Mediterranean Diet; Lifestyle
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 18/NI/0077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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