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Clinical Trials/NCT04096404
NCT04096404
Unknown
Not Applicable

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 sites400 target enrollmentSeptember 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adiposity
Sponsor
St Mary's University College
Enrollment
400
Primary Endpoint
Body weight in kg
Last Updated
6 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2019
End Date
September 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St Mary's University College
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18-25 years

Exclusion Criteria

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

Outcomes

Primary Outcomes

Body weight in kg

Time Frame: 3 years

Weight will be measured to the nearest 0.1 kg

Body fat percentage

Time Frame: 3 years

Body fat percentage will be measured to the nearest 0.1%

Body mass index in Kg/m2

Time Frame: 3 years

calculated from measured height and weight

Secondary Outcomes

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

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