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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04654936
Recruitment Status : Completed
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Deirdre Timlin, University of Ulster

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognitive Change Behavioral: MIND diet Behavioral: MIND diet with no support Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This study includes 2 intervention arms and one control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility and Acceptability of a 12 Week Online Dietary Intervention Promoting the MIND Diet Using the COM-B Model
Actual Study Start Date : May 16, 2019
Actual Primary Completion Date : November 6, 2019
Actual Study Completion Date : November 6, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive function [ Time Frame: 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 :
  1. Mood [ Time Frame: 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.

  2. World Health Organisation Bref Quality of life [ Time Frame: 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.

  3. Capability, opportunity, motivation and behaviour model [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654936


Locations
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United Kingdom
Life and Health Science
Derry, United Kingdom
Sponsors and Collaborators
University of Ulster
Investigators
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Principal Investigator: Liz Simpson, PhD Ulster University
More Information
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Responsible Party: Deirdre Timlin, Principle investigator, University of Ulster
ClinicalTrials.gov Identifier: NCT04654936    
Other Study ID Numbers: DTimlin
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No