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临床试验/NCT04096404
NCT04096404Unknown不适用

A Longitudinal Study to Determine the Effect of Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students

St Mary's University College0 个研究点目标入组 400 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
400
主要终点
Body weight in kg

研究概览

简要总结

A longitudinal study to determine the effect of gene-based personalised diet and physical activity advice on adiposity indices in university students.

详细描述

The study uses a randomised controlled design; data for all variables (participant characteristics, height, weight, body mass index (BMI), waist circumference (WC), body fat percentage (BF%), healthy eating motivation, dietary intake and physical activity) will be collected initially from participants at St Mary's University during September and October 2019. Participants will be genotyped, stratified randomisation (based on genotype and BMI) will be used to allocate participants to three different groups (1. Control: no advice, 2. Non genetic personalised advice: dietary and physical activity advice based on reported dietary intake and physical activity 3. Genotype- based personalised advice: dietary and physical activity advice based on genotype, reported dietary intake and physical activity. Following allocation to groups participants in groups 2 and 3 will receive appropriate dietary and physical activity advice via email (appendix a) and all participants will complete the healthy eating motivation questionnaire for a second time. In April/May 2020 follow up variables (smoking status, weight, BMI, WC, BF%, healthy eating motivation, dietary intake and physical activity) will be measured again. These follow up variables will be measured every September and April/May until September 2022. After each follow up participants in groups 2 and 3 will be resent their dietary and physical activity advice and updated information based on their reported dietary intake and physical activity.

研究设计

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

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-25 years

排除标准

  • Pregnancy and lactation
  • Chronic disease
  • A history of disordered eating and following a restricted diet.

研究组 & 干预措施

Genotype- based personalised advice

Experimental

dietary and physical activity advice based on genotype, reported dietary intake and physical activity

干预措施: Genotype- based personalised advice (Genetic)

Genotype- based personalised advice

Experimental

dietary and physical activity advice based on genotype, reported dietary intake and physical activity

干预措施: Non genetic personalised advice (Behavioral)

Control

No Intervention

no advice

Non genetic personalised advice

Active Comparator

dietary and physical activity advice based on reported dietary intake and physical activity

干预措施: Non genetic personalised advice (Behavioral)

结局指标

主要结局

Body weight in kg

时间窗: 3 years

Weight will be measured to the nearest 0.1 kg

Body fat percentage

时间窗: 3 years

Body fat percentage will be measured to the nearest 0.1%

Body mass index in Kg/m2

时间窗: 3 years

calculated from measured height and weight

次要结局

  • Dietary intake(3 years)
  • Physical activity(3 years)
  • Participants motivation to eat healthily(3 years)

研究者

发起方
St Mary's University College
申办方类型
Other
责任方
Sponsor

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