Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

NCT ID: NCT03265522

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-06-30

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:

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).

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1: "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 (n=20)

Group Type: EXPERIMENTAL

"ThinkMed" resource at baseline

Intervention Type: BEHAVIORAL

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.

Group 2: "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 (n=20)

Group Type: EXPERIMENTAL

"ThinkMed" resource (staged)

Intervention Type: BEHAVIORAL

This group of participants will receive the "ThinkMed" resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian

Group 3: Standard Care (control) group

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)

Group Type: PLACEBO_COMPARATOR

Standard Care Control

Intervention Type: BEHAVIORAL

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).

Interventions

"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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

"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

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellcome Trust

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Jayne Woodside, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jayne Woodside, PhD

Role: PRINCIPAL_INVESTIGATOR

Queens University Belfast

Locations

Belfast Health and Social Care Trust

Belfast, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33390187 (View on PubMed)

Other Identifiers

16/NI/0105

Identifier Type: -

Identifier Source: org_study_id