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

NCT ID: NCT04654936

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-16

Study Completion Date

2019-11-06

Brief Summary

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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

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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

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Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This study includes 2 intervention arms and one control group
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MIND diet with support

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

Group Type EXPERIMENTAL

MIND diet

Intervention Type 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 no support

This group are to follow the MIND diet guidelines with no website support

Group Type EXPERIMENTAL

MIND diet with no support

Intervention Type 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

Control

The group follow usual diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MIND 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

Intervention Type BEHAVIORAL

MIND 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Deirdre Timlin

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liz Simpson, PhD

Role: PRINCIPAL_INVESTIGATOR

Ulster University

Locations

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Life and Health Science

Londonderry, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 40134050 (View on PubMed)

Other Identifiers

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DTimlin

Identifier Type: -

Identifier Source: org_study_id

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