Cognitive ChangeNCT04654936
Effectiveness of a 12 Week Theory Driven Intervention Promoting Adherence to the MIND Diet
A study testing MIND diet and MIND diet with no support in people with Cognitive Change, run by University of Ulster at 1 site in United Kingdom.
Trial summary
This study aims to test the feasibility and acceptability of a 12 week online dietary promoting MIND diet behaviour. This study also tests the effectiveness of the MIND diet on cognitive function, mood, quality of life and participants capability, opportunity and motivation towards adoption of the MIND diet. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- MIND diet and MIND diet with no support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2019to 6 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- . Healthy male and female aged 40-55 living in NI
Who cannot join
- Anyone on a specific dietary pattern (veganism, vegetarian, Atkins)
- Anyone on a specific diet recommended by their Doctor (eating disorder)
- Specific illnesses such as high cholesterol, diabetes, heart disease, dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of a 12 Week Online Dietary Intervention Promoting the MIND Diet Using the COM-B Model
This study aims to test the feasibility and acceptability of a 12 week online dietary promoting MIND diet behaviour. This study also tests the effectiveness of the MIND diet on cognitive function, mood, quality of life and participants capability, opportunity and motivation towards adoption of the MIND diet.
Read the detailed description
This study is a randomized controlled prospective follow up study, condition (control Vs intervention) x time(baseline Vs follow up) ANOVA with repeated measures design. Outcome measures for COM-B, cognitive function, mood and quality of life were recorded for both the intervention and control groups. With power set at .80, and alpha = .05, G*Power indicated that a sample size of 36 would be required. Forty-one participants took part in the study. Participants were healthy male, and female aged between 40-55 years old living in Northern Ireland.
There are 2 intervention arms and one control group. The intervention was designed using the Behaviour Change Wheel, with prior qualitative research informing the intervention.
All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) with significance set at P < 0.05 throughout
- Conditions
- Cognitive Change
- Being tested
- MIND diet, MIND diet with no support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND dietBehavioural
12 week MIND diet study: Participants access a website that is theory driven using the Behaviour Change Wheel to help motivate and promote MIND diet adherence. Participants are to consume MIND diet foods daily and meet MIND diet weekly recommendations
MIND diet with no supportBehavioural
Participants are to consume MIND diet food recommendations over a 12 week period with no support except for a self-monitoring resource and MIND diet guidelines
| Study group | Role | What they receive |
|---|---|---|
| MIND diet with support | Experimental | This intervention group are to follow the MIND diet guidelines for 12 weeks with the support of a 12 week online theory driven website and resources Receives: Behavioral: MIND diet |
| MIND diet no support | Experimental | This group are to follow the MIND diet guidelines with no website support Receives: Behavioral: MIND diet with no support |
| Control | No intervention | The group follow usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Tests used for this study were spatial working memory (SWM), spatial span (SSP), pattern recognition memory (PRM) and reaction time (RTI). These tests are computerised and measure the length of time it takes to complete task in milliseconds.
Measured: 12 weeks
Secondary outcomes (3)
Mood
Positive and Negative Affect Scale bref was used to measure mood 4 times a day over 4 days at baseline and follow-up. The maximum score for positive affect is 50 with higher scores representing higher levels of positive affect. Negative affect scores are a maximum of 50 with lower scores representing lower levels of negative affect.
Measured: 12 weeks
World Health Organisation Bref Quality of life
WHO bref questionnaire was used to measure quality of life at baseline and follow up. The maximum score is 100, with higher scores representing higher quality of life.
Measured: 12 weeks
Capability, opportunity, motivation and behaviour model
COM-B questionnaire measuring participants capability opportunity and motivation towards adoption of the MIND diet at baseline and follow up. Maximum scores are 110 with higher scores representing higher capability, opportunity, motivation towards MIND diet behaviour.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start16 May 2019
- Primary completion6 Nov 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study includes 2 intervention arms and one control group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deirdre Timlin, University of Ulster
- Investigators
- Liz Simpson, PhD, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654936
- Sponsor's protocol ID
- DTimlin
- Status last verified
- Dec 2020
- First submitted
- 5 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Timlin D, McCormack JM, Kerr M, Keaver L, Simpson EEA. The MIND diet, cognitive function, and well-being among healthy adults at midlife: a randomised feasibility trial. BMC Nutr. 2025 Mar 25;11(1):59. doi: 10.1186/s40795-025-01020-6.
PubMed 40134050
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a 12 Week Online Dietary Intervention Promoting the MIND Diet Using the COM-B Model
- ClinicalTrials.gov ID
- NCT04654936
- Acronym / sponsor ID
- DTimlin
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the feasibility and acceptability of a 12 week online dietary promoting MIND diet behaviour. This study also tests the effectiveness of the MIND diet on cognitive function, mood, quality of life and participants capability, opportunity and motivation towards adoption of the MIND diet.
Detailed description
This study is a randomized controlled prospective follow up study, condition (control Vs intervention) x time(baseline Vs follow up) ANOVA with repeated measures design. Outcome measures for COM-B, cognitive function, mood and quality of life were recorded for both the intervention and control groups. With power set at .80, and alpha = .05, G*Power indicated that a sample size of 36 would be required. Forty-one participants took part in the study. Participants were healthy male, and female aged between 40-55 years old living in Northern Ireland.
There are 2 intervention arms and one control group. The intervention was designed using the Behaviour Change Wheel, with prior qualitative research informing the intervention.
All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) with significance set at P < 0.05 throughout
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study includes 2 intervention arms and one control group
| Arm | Type | Receives |
|---|---|---|
| MIND diet with support | Experimental | Behavioral: MIND dietThis intervention group are to follow the MIND diet guidelines for 12 weeks with the support of a 12 week online theory driven website and resources |
| MIND diet no support | Experimental | Behavioral: MIND diet with no supportThis group are to follow the MIND diet guidelines with no website support |
| Control | No intervention | –The group follow usual diet |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- . Healthy male and female aged 40-55 living in NI
Key exclusion criteria (3 listed)
- Anyone on a specific dietary pattern (veganism, vegetarian, Atkins)
- Anyone on a specific diet recommended by their Doctor (eating disorder)
- Specific illnesses such as high cholesterol, diabetes, heart disease, dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIND diet12 week MIND diet study: Participants access a website that is theory driven using the Behaviour Change Wheel to help motivate and promote MIND diet adherence. Participants are to consume MIND diet foods daily and meet MIND diet weekly recommendations | Behavioural | MIND diet with support |
| MIND diet with no supportParticipants are to consume MIND diet food recommendations over a 12 week period with no support except for a self-monitoring resource and MIND diet guidelines | Behavioural | MIND diet no support |
Primary outcome
Cognitive function
Time frame: 12 weeks
Tests used for this study were spatial working memory (SWM), spatial span (SSP), pattern recognition memory (PRM) and reaction time (RTI). These tests are computerised and measure the length of time it takes to complete task in milliseconds.
3 secondary outcomes
Mood
Time frame: 12 weeks
World Health Organisation Bref Quality of life
Time frame: 12 weeks
Capability, opportunity, motivation and behaviour model
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Derived from this study: PubMed 40134050Timlin D, McCormack JM, Kerr M, Keaver L, Simpson EEA. The MIND diet, cognitive function, and well-being among healthy adults at midlife: a randomised feasibility trial. BMC Nutr. 2025 Mar 25;11(1):59. doi: 10.1186/s40795-025-01020-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liz Simpson, PhD principal investigator
Ulster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND diet and MIND diet with no support in people with Cognitive Change, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04654936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.