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

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654936
• Other study ID #: DTimlin
• Status: Completed
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: November 6, 2019

Study information

• Verified date: December 2020
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 6, 2019
• Est. primary completion date: November 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
United Kingdom	Life and Health Science	Derry

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	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.	12 weeks
Secondary	Mood	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.	12 weeks
Secondary	World Health Organisation Bref Quality of life	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.	12 weeks
Secondary	Capability, opportunity, motivation and behaviour model	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.	12 weeks