Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment

NCT03265522 | Completed

• 1 other identifier: 16/NI/0105
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Mediterranean diet; Lifestyle

Outcome Measures

Primary Outcomes (1)

• Change in Mediterranean Diet Score (MDS) at 6 months

  Mediterranean dietary intake will be measured by a validated questionnaire

  Baseline, 6 months

Secondary Outcomes (17)

• Physical Activity

  Baseline, 6 months

• Anthropometric measurements

  Baseline, 6 months

• Muscle Strength

  Baseline, 6 months

• Geriatric Depression Scale

  Baseline, 6 months

• Functional Assessment (1)

  Baseline, 6 months

Other Outcomes (3)

• Process Evaluation (1) - telephone contact evaluation

  up to 3 months post intervention

• Process Evaluation (2) - study records

  up to 3 months post intervention

• Process Evaluation (3) - structured interviews

  up to 3 months post intervention

Study Arms (3)

Group 1: "ThinkMed" resource at baseline

EXPERIMENTAL

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)

Behavioral: "ThinkMed" resource at baseline

Group 2: "ThinkMed" resource (staged)

EXPERIMENTAL

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)

Behavioral: "ThinkMed" resource (staged)

Group 3: Standard Care (control) group

PLACEBO COMPARATOR

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)

Behavioral: Standard Care Control

Interventions

"ThinkMed" resource at baseline 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 1: "ThinkMed" resource at baseline

Standard Care Control 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).

Group 3: Standard Care (control) group

"ThinkMed" resource (staged) 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 2: "ThinkMed" resource (staged)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Wellcome Trust: collaborator

Study Sites (1)

Belfast Health and Social Care Trust

Belfast, BT9 7AB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33390187 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jayne Woodside, PhD

  Queens University Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 29, 2017
• Study Start: May 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-11

Locations

GB (1)