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Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
"ThinkMed" resource at baseline
Standard Care Control
"ThinkMed" resource (staged)
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Mediterranean diet, Lifestyle

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Belfast Health and Social Care Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1: "ThinkMed" resource at baseline

Group 2: "ThinkMed" resource (staged)

Group 3: Standard Care (control) group

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Change in Mediterranean Diet Score (MDS) at 6 months
Mediterranean dietary intake will be measured by a validated questionnaire

Secondary Outcome Measures

Physical Activity
RPAQ-Recent Physical Activity Questionnaire
Anthropometric measurements
Weight and height measurements to calculate BMI
Muscle Strength
Measured using a grip-strength dynamometer
Geriatric Depression Scale
Geriatric Depression Scale Questionnaire
Functional Assessment (1)
Measured by the instrumental activities of daily living scale (IADL) by Lawton and Brody (1969) questionnaire
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.)
Barriers to consuming a Mediterranean Diet questionnaire
Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet
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.
Functional Assessment (2)
Measured by the Bristol activities of daily living scale (Bucks et al. 1996) questionnaire
4-day Food Diary
A food diary will be completed to assess compliance with a Mediterranean diet
Change in Lifestyle questionnaire
A questionnaire to measure change in lifestyle behaviours
Dietary Quality of Life questionnaire
A questionnaire to measure dietary quality of life
Mediterranean Diet Knowledge questionnaire
A questionnaire to measure participants Mediterranean diet knowledge
Rand SF-36 HEALTH SURVEY
A questionnaire to measure participants views and beliefs on health
Staging Algorithm Questionnaire
A questionnaire to measure participants readiness to change their diet and lifestyle
Mediterranean Diet self-efficacy questionnaire
A questionnaire to measure participants self-efficacy
Mediterranean diet tolerance questionnaire
A questionnaire to measure tolerance to a Mediterranean diet

Full Information

First Posted
August 23, 2017
Last Updated
November 1, 2019
Sponsor
Queen's University, Belfast
Collaborators
Wellcome Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03265522
Brief Title
Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment
Official Title
The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Patients With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
Wellcome Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Group 1 will receive the Mediterranean lifestyle education resource on one occasion at baseline Group 2 will receive the Mediterranean lifestyle education resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mediterranean diet, Lifestyle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: "ThinkMed" resource at baseline
Arm Type
Experimental
Arm Description
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)
Arm Title
Group 2: "ThinkMed" resource (staged)
Arm Type
Experimental
Arm Description
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)
Arm Title
Group 3: Standard Care (control) group
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
"ThinkMed" resource at baseline
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care Control
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
"ThinkMed" resource (staged)
Intervention Description
This group of participants will receive the "ThinkMed" resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian
Primary Outcome Measure Information:
Title
Change in Mediterranean Diet Score (MDS) at 6 months
Description
Mediterranean dietary intake will be measured by a validated questionnaire
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Physical Activity
Description
RPAQ-Recent Physical Activity Questionnaire
Time Frame
Baseline, 6 months
Title
Anthropometric measurements
Description
Weight and height measurements to calculate BMI
Time Frame
Baseline, 6 months
Title
Muscle Strength
Description
Measured using a grip-strength dynamometer
Time Frame
Baseline, 6 months
Title
Geriatric Depression Scale
Description
Geriatric Depression Scale Questionnaire
Time Frame
Baseline, 6 months
Title
Functional Assessment (1)
Description
Measured by the instrumental activities of daily living scale (IADL) by Lawton and Brody (1969) questionnaire
Time Frame
Baseline, 6 months
Title
Cognitive Assessment
Description
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.)
Time Frame
Baseline, 6 months
Title
Barriers to consuming a Mediterranean Diet questionnaire
Description
Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet
Time Frame
Baseline, 6 months
Title
Blood Sample
Description
A blood sample will be taken from participants to be stored for analysis of biomarkers of MD adherence and biomarkers of neurodegenerative disease risk.
Time Frame
Baseline, 6 months
Title
Functional Assessment (2)
Description
Measured by the Bristol activities of daily living scale (Bucks et al. 1996) questionnaire
Time Frame
Baseline, 6 months
Title
4-day Food Diary
Description
A food diary will be completed to assess compliance with a Mediterranean diet
Time Frame
Baseline, 6 months
Title
Change in Lifestyle questionnaire
Description
A questionnaire to measure change in lifestyle behaviours
Time Frame
Baseline, 6 months
Title
Dietary Quality of Life questionnaire
Description
A questionnaire to measure dietary quality of life
Time Frame
Baseline, 6 months
Title
Mediterranean Diet Knowledge questionnaire
Description
A questionnaire to measure participants Mediterranean diet knowledge
Time Frame
Baseline, 6 months
Title
Rand SF-36 HEALTH SURVEY
Description
A questionnaire to measure participants views and beliefs on health
Time Frame
Baseline, 6 months
Title
Staging Algorithm Questionnaire
Description
A questionnaire to measure participants readiness to change their diet and lifestyle
Time Frame
Baseline, 6 months
Title
Mediterranean Diet self-efficacy questionnaire
Description
A questionnaire to measure participants self-efficacy
Time Frame
Baseline, 6 months
Title
Mediterranean diet tolerance questionnaire
Description
A questionnaire to measure tolerance to a Mediterranean diet
Time Frame
Baseline, 6 months
Other Pre-specified Outcome Measures:
Title
Process Evaluation (1) - telephone contact evaluation
Description
Determination individual participation and engagement with the intervention by reviewing telephone contact log record and telephone checklist evaluation
Time Frame
up to 3 months post intervention
Title
Process Evaluation (2) - study records
Description
A review of study records- including attrition rates, reason for dropout
Time Frame
up to 3 months post intervention
Title
Process Evaluation (3) - structured interviews
Description
Post intervention structured interviews for participant evaluation of the intervention programme and dietary educational materials
Time Frame
up to 3 months post intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayne Woodside, PhD
Organizational Affiliation
Queens University Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Belfast Health and Social Care Trust
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33390187
Citation
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.
Results Reference
derived

Learn more about this trial

Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

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