Clinical trial NCT03265522: Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment
Official title: The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mediterranean diet
Lifestyle
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2017-08-29
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change in Mediterranean Diet Score (MDS) at 6 months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Physical Activity
timeFrame: Baseline, 6 months
measure: Anthropometric measurements
timeFrame: Baseline, 6 months
measure: Muscle Strength
timeFrame: Baseline, 6 months
measure: Geriatric Depression Scale
timeFrame: Baseline, 6 months
measure: Functional Assessment (1)
timeFrame: Baseline, 6 months
measure: Cognitive Assessment
timeFrame: Baseline, 6 months
measure: Barriers to consuming a Mediterranean Diet questionnaire
timeFrame: Baseline, 6 months
measure: Blood Sample
timeFrame: Baseline, 6 months
measure: Functional Assessment (2)
timeFrame: Baseline, 6 months
measure: 4-day Food Diary
timeFrame: Baseline, 6 months
measure: Change in Lifestyle questionnaire
timeFrame: Baseline, 6 months
measure: Dietary Quality of Life questionnaire
timeFrame: Baseline, 6 months
measure: Mediterranean Diet Knowledge questionnaire
timeFrame: Baseline, 6 months
measure: Rand SF-36 HEALTH SURVEY
timeFrame: Baseline, 6 months
measure: Staging Algorithm Questionnaire
timeFrame: Baseline, 6 months
measure: Mediterranean Diet self-efficacy questionnaire
timeFrame: Baseline, 6 months
measure: Mediterranean diet tolerance questionnaire
timeFrame: Baseline, 6 months
Other outcomes:
measure: Process Evaluation (1) - telephone contact evaluation
timeFrame: up to 3 months post intervention
measure: Process Evaluation (2) - study records
timeFrame: up to 3 months post intervention
measure: Process Evaluation (3) - structured interviews
timeFrame: up to 3 months post intervention
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
Study officials:
affiliation: Queens University Belfast
name: Jayne Woodside, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.