The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Participants With Subjective Cognitive Impairment
Sponsor study identifier
interventional
5
1 country
1
Study Start
May 18, 2018
Actual (reported)Primary Completion
June 30, 2019
Actual (reported)Study Completion
June 30, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 18, 2018
Actual (reported)June 3, 2018
Actual (reported)June 26, 2018
Actual (reported)June 30, 2019
Actual (reported)June 30, 2019
Actual (reported)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
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
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
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)
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)
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.
This group of participants will receive the "THINK-MED" resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian
Queen's University
Belfast, United Kingdom
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.
Jayne Woodside, PhD
Queen's University, Belfast
5 participants (actual enrollment reported by the registry).
First Submitted
June 3, 2018
First Posted
June 26, 2018
Study Start
May 18, 2018
Actual (reported)Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial
Participants will receive the "THINK-MED" resource after their final 6 month study visit (i.e. delayed intervention) (n=10)
Participants will receive the "THINK-MED" resource after their final 6 month study visit (i.e. delayed intervention).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2019
Actual (reported)Study Completion
June 30, 2019
Actual (reported)Last Updated
April 3, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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