Clinical trial NCT03569319: Tailored Mediterranean Lifestyle Education in Participants With Subjective Cognitive Impairment
Official title: The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Participants With Subjective Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Cognitive Impairment
Keywords: Mediterranean Diet
Lifestyle
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2018-06-26
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mediterranean Diet Score (MDS) at 6 months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in Physical Activity at 6 months
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: Functional Assessment (2)
timeFrame: Baseline, 6 months
measure: Cognitive Assessment
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 Short Form-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: Barriers to consuming a Mediterranean Diet questionnaire
timeFrame: Baseline, 6 months
measure: Blood Sample
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: Queen's University
Study officials:
affiliation: Queen's 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.