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

Not Applicable

Completed

• Conditions: Cognitive Change
• Interventions: Behavioral: MIND diet; Behavioral: MIND diet with no support

• Registration Number: NCT04654936
• Lead Sponsor: University of Ulster

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

Study Timeline

• Study Start: 2019-05-16
• Primary Completion: 2019-11-06
• Study Completion: 2019-11-06
• Study First Submitted: 2020-11-05
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-03
• Last Update Submitted: 2020-12-03
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cognitive function	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 Outcome Measures

Name	Time	Method
Capability, opportunity, motivation and behaviour model	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.
Mood	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.
World Health Organisation Bref Quality of life	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.

Trial Locations

Locations (1)

Life and Health Science; 🇬🇧 Derry, United Kingdom