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Effectiveness of a 12 Week Theory Driven Intervention Promoting Adherence to the MIND Diet

Feasibility and Acceptability of a 12 Week Online Dietary Intervention Promoting the MIND Diet Using the COM-B Model

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04654936
Enrollment
41
Registered
2020-12-04
Start date
2019-05-16
Completion date
2019-11-06
Last updated
2020-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Change

Brief 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.

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

Interventions

BEHAVIORALMIND diet

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

BEHAVIORALMIND diet with no support

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

Sponsors

University of Ulster
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

This study includes 2 intervention arms and one control group

Eligibility

Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

. Healthy male and female aged 40-55 living in NI

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive function12 weeksTests 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.

Secondary

MeasureTime frameDescription
Mood12 weeksPositive 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.
World Health Organisation Bref Quality of life12 weeksWHO 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.
Capability, opportunity, motivation and behaviour model12 weeksCOM-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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026