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临床试验/NCT04654936
NCT04654936已完成不适用

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

University of Ulster1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年5月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Cognitive function

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •. Healthy male and female aged 40-55 living in NI

排除标准

  • •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.

研究组 & 干预措施

MIND diet with support

Experimental

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

干预措施: MIND diet (Behavioral)

MIND diet no support

Experimental

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

干预措施: MIND diet with no support (Behavioral)

Control

No Intervention

The group follow usual diet

结局指标

主要结局

Cognitive function

时间窗: 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.

次要结局

  • Capability, opportunity, motivation and behaviour model(12 weeks)
  • Mood(12 weeks)
  • World Health Organisation Bref Quality of life(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deirdre Timlin

Principle investigator

University of Ulster

研究点 (1)

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