Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

Queen's University Belfast

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Standard Care Control; Behavioral: "ThinkMed" resource at baseline; Behavioral: "ThinkMed" resource (staged)

Study type: Interventional

Funder types: Other

Identifiers

NCT03265522

16/NI/0105

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups, including a placebo group

Group 1: "ThinkMed" resource at baseline

Experimental group

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)

Treatment:

Behavioral: "ThinkMed" resource at baseline

Group 2: "ThinkMed" resource (staged)

Experimental group

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)

Treatment:

Behavioral: "ThinkMed" resource (staged)

Group 3: Standard Care (control) group

Placebo Comparator group

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)

Treatment:

Behavioral: Standard Care Control