Tailored Mediterranean Lifestyle Education in Participants With Subjective Cognitive Impairment

NCT03569319 | Completed

• 1 other identifier: 18/NI/0077
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective 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 with a increase in score by greater than or equal to 3 points at 6 months indicating adoption (maximum score 14)

  Baseline, 6 months

Secondary Outcomes (16)

• Change in Physical Activity at 6 months

  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: "THINK-MED" resource (baseline)

EXPERIMENTAL

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)

Behavioral: "THINK-MED" resource (baseline)

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

EXPERIMENTAL

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)

Behavioral: "THINK-MED" resource (staged)

Group 3: Control

PLACEBO COMPARATOR

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

Behavioral: Control

Interventions

"THINK-MED" resource (baseline) BEHAVIORAL

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.

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

"THINK-MED" resource (staged) BEHAVIORAL

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

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

Control BEHAVIORAL

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

Group 3: Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Queen's University

Belfast, 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

Interventions

BaseLine dental cement

Study Officials

• Jayne Woodside, PhD

  Queen's 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: June 3, 2018
• First Posted: June 26, 2018
• Study Start: May 18, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

GB (1)