Tailored Mediterranean Lifestyle Education in Participants With Subjective Cognitive Impairment

Subjective Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03569319
• Other study ID #: 18/NI/0077
• Status: Completed
• Phase: N/A
• Start date: May 18, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2024
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• 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:

• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Subjective Cognitive Impairment

Intervention

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.
• "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
• Control
Participants will receive the "THINK-MED" resource after their final 6 month study visit (i.e. delayed intervention).

Locations

Country	Name	City	State
United Kingdom	Queen's University	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 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	Change in Physical Activity at 6 months	Physical activity will be measured by the Recent Physical Activity Questionnaire (RPAQ)	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	Depressive symptoms will be measured by the Geriatric Depression Scale Questionnaire, with a score greater than 5 indicating depressive symptoms	Baseline, 6 months
Secondary	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
Secondary	Functional Assessment (2)	Measured by the Bristol activities of daily living (Bucks et al. 1996) 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	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 Short Form-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	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