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NCT Number: NCT04654936

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

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.

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Key information

Conditions

Cognitive Change

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Life and Health Science

Londonderry, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MIND diet

Behavioral

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 support

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mood

    Time frame: 12 weeks

    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.

  2. World Health Organisation Bref Quality of life

    Time frame: 12 weeks

    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.

  3. Capability, opportunity, motivation and behaviour model

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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