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

U

Ulster University

Status

Completed

Conditions

Cognitive Change

Treatments

Behavioral: MIND diet
Behavioral: MIND diet with no support

Study type

Interventional

Funder types

Other

Identifiers

NCT04654936
DTimlin

Details and patient eligibility

About

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.

Full 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

Enrollment

41 patients

Sex

All

Ages

40 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

41 participants in 3 patient groups

MIND diet with support
Experimental group
Description:
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
Treatment:
Behavioral: MIND diet
MIND diet no support
Experimental group
Description:
This group are to follow the MIND diet guidelines with no website support
Treatment:
Behavioral: MIND diet with no support
Control
No Intervention group
Description:
The group follow usual diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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