Tailored Mediterranean Lifestyle Education in Participants With Subjective Cognitive Impairment

Queen's University Belfast

Status: Completed

Conditions: Subjective Cognitive Impairment

Treatments: Behavioral: "THINK-MED" resource (baseline); Behavioral: Control; Behavioral: "THINK-MED" resource (staged)

Study type: Interventional

Funder types: Other

Identifiers

NCT03569319

18/NI/0077

Details and patient eligibility

About

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.

Full 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)

Enrollment: 5 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 3 patient groups, including a placebo group

Group 1: "THINK-MED" resource (baseline)

Experimental group

Description:

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)

Treatment:

Behavioral: "THINK-MED" resource (baseline)

Group 2: "THINK-MED" resource (staged)

Experimental group

Description:

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)

Treatment:

Behavioral: "THINK-MED" resource (staged)

Group 3: Control

Placebo Comparator group

Description:

Participants will receive the "THINK-MED" resource after their final 6 month study visit (i.e. delayed intervention) (n=10)

Treatment:

Behavioral: Control