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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Behavioral: MIND diet; Behavioral: MIND diet with no support

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derry, United Kingdom
    • Life and Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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
EXPERIMENTAL: MIND diet no support; This group are to follow the MIND diet guidelines with no website support	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
NO_INTERVENTION: Control; The group follow usual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Ulster
• Investigators: Principal Investigator: Liz Simpson, PhD, Ulster University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2019
• Primary Completion (ACTUAL): November 6, 2019
• Study Completion (ACTUAL): November 6, 2019

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (ACTUAL): December 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DTimlin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No