Mild Cognitive Impairment Clinical Trial
Official title:
The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Patients With Mild Cognitive Impairment
NCT number | NCT03265522 |
Other study ID # | 16/NI/0105 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | June 30, 2019 |
Verified date | November 2019 |
Source | Queen's University, Belfast |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast Health and Social Care Trust | Belfast |
Lead Sponsor | Collaborator |
---|---|
Queen's University, Belfast | Wellcome Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Process Evaluation (1) - telephone contact evaluation | Determination individual participation and engagement with the intervention by reviewing telephone contact log record and telephone checklist evaluation | up to 3 months post intervention | |
Other | Process Evaluation (2) - study records | A review of study records- including attrition rates, reason for dropout | up to 3 months post intervention | |
Other | Process Evaluation (3) - structured interviews | Post intervention structured interviews for participant evaluation of the intervention programme and dietary educational materials | up to 3 months post intervention | |
Primary | Change in Mediterranean Diet Score (MDS) at 6 months | Mediterranean dietary intake will be measured by a validated questionnaire | Baseline, 6 months | |
Secondary | Physical Activity | RPAQ-Recent Physical Activity Questionnaire | Baseline, 6 months | |
Secondary | Anthropometric measurements | Weight and height measurements to calculate BMI | Baseline, 6 months | |
Secondary | Muscle Strength | Measured using a grip-strength dynamometer | Baseline, 6 months | |
Secondary | Geriatric Depression Scale | Geriatric Depression Scale Questionnaire | Baseline, 6 months | |
Secondary | Functional Assessment (1) | Measured by the instrumental activities of daily living scale (IADL) by Lawton and Brody (1969) questionnaire | Baseline, 6 months | |
Secondary | Cognitive Assessment | A comprehensive cognitive assessment will be performed, including: global cognition, motor skills, executive function episodic/visual memory, and information processing and sustained attention using a validated neuropsychological test battery (Cantab Cognitive Battery, Cambridge Cognition Ltd.) | Baseline, 6 months | |
Secondary | Barriers to consuming a Mediterranean Diet questionnaire | Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet | Baseline, 6 months | |
Secondary | Blood Sample | A blood sample will be taken from participants to be stored for analysis of biomarkers of MD adherence and biomarkers of neurodegenerative disease risk. | Baseline, 6 months | |
Secondary | Functional Assessment (2) | Measured by the Bristol activities of daily living scale (Bucks et al. 1996) questionnaire | Baseline, 6 months | |
Secondary | 4-day Food Diary | A food diary will be completed to assess compliance with a Mediterranean diet | Baseline, 6 months | |
Secondary | Change in Lifestyle questionnaire | A questionnaire to measure change in lifestyle behaviours | Baseline, 6 months | |
Secondary | Dietary Quality of Life questionnaire | A questionnaire to measure dietary quality of life | Baseline, 6 months | |
Secondary | Mediterranean Diet Knowledge questionnaire | A questionnaire to measure participants Mediterranean diet knowledge | Baseline, 6 months | |
Secondary | Rand SF-36 HEALTH SURVEY | A questionnaire to measure participants views and beliefs on health | Baseline, 6 months | |
Secondary | Staging Algorithm Questionnaire | A questionnaire to measure participants readiness to change their diet and lifestyle | Baseline, 6 months | |
Secondary | Mediterranean Diet self-efficacy questionnaire | A questionnaire to measure participants self-efficacy | Baseline, 6 months | |
Secondary | Mediterranean diet tolerance questionnaire | A questionnaire to measure tolerance to a Mediterranean diet | Baseline, 6 months |
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