Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265522
• Other study ID #: 16/NI/0105
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2019
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.
• 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).
• "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

Locations

Country	Name	City	State
United Kingdom	Belfast Health and Social Care Trust	Belfast

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University, Belfast	Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Process Evaluation (2) - study records	A review of study records- including attrition rates, reason for dropout	up to 3 months post intervention
Other	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
Primary	Change in Mediterranean Diet Score (MDS) at 6 months	Mediterranean dietary intake will be measured by a validated questionnaire	Baseline, 6 months
Secondary	Physical Activity	RPAQ-Recent Physical Activity Questionnaire	Baseline, 6 months
Secondary	Anthropometric measurements	Weight and height measurements to calculate BMI	Baseline, 6 months
Secondary	Muscle Strength	Measured using a grip-strength dynamometer	Baseline, 6 months
Secondary	Geriatric Depression Scale	Geriatric Depression Scale Questionnaire	Baseline, 6 months
Secondary	Functional Assessment (1)	Measured by the instrumental activities of daily living scale (IADL) by Lawton and Brody (1969) questionnaire	Baseline, 6 months
Secondary	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
Secondary	Barriers to consuming a Mediterranean Diet questionnaire	Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet	Baseline, 6 months
Secondary	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
Secondary	Functional Assessment (2)	Measured by the Bristol activities of daily living scale (Bucks et al. 1996) questionnaire	Baseline, 6 months
Secondary	4-day Food Diary	A food diary will be completed to assess compliance with a Mediterranean diet	Baseline, 6 months
Secondary	Change in Lifestyle questionnaire	A questionnaire to measure change in lifestyle behaviours	Baseline, 6 months
Secondary	Dietary Quality of Life questionnaire	A questionnaire to measure dietary quality of life	Baseline, 6 months
Secondary	Mediterranean Diet Knowledge questionnaire	A questionnaire to measure participants Mediterranean diet knowledge	Baseline, 6 months
Secondary	Rand SF-36 HEALTH SURVEY	A questionnaire to measure participants views and beliefs on health	Baseline, 6 months
Secondary	Staging Algorithm Questionnaire	A questionnaire to measure participants readiness to change their diet and lifestyle	Baseline, 6 months
Secondary	Mediterranean Diet self-efficacy questionnaire	A questionnaire to measure participants self-efficacy	Baseline, 6 months
Secondary	Mediterranean diet tolerance questionnaire	A questionnaire to measure tolerance to a Mediterranean diet	Baseline, 6 months