Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students

Not Applicable

• Conditions: Adiposity; Behavior, Health
• Interventions: Genetic: Genotype- based personalised advice; Behavioral: Non genetic personalised advice

• Registration Number: NCT04096404
• Lead Sponsor: St Mary's University College

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.

Study Timeline

• Study First Submitted: 2019-08-16
• Status Verified: 2019-09
• Study Start: 2019-09
• Study First Submitted QC: 2019-09-17
• Last Update Submitted: 2019-09-17
• Study First Posted: 2019-09-19
• Last Update Posted: 2019-09-19
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age 18-25 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genotype- based personalised advice	Genotype- based personalised advice	dietary and physical activity advice based on genotype, reported dietary intake and physical activity
Non genetic personalised advice	Non genetic personalised advice	dietary and physical activity advice based on reported dietary intake and physical activity
Genotype- based personalised advice	Non genetic personalised advice	dietary and physical activity advice based on genotype, reported dietary intake and physical activity

Primary Outcome Measures

Name	Time	Method
Body mass index in Kg/m2	3 years	calculated from measured height and weight
Body fat percentage	3 years	Body fat percentage will be measured to the nearest 0.1%
Body weight in kg	3 years	Weight will be measured to the nearest 0.1 kg

Secondary Outcome Measures

Name	Time	Method
Dietary intake	3 years	using a four day food diary collected using a food diary and nutritional analysis app (Libro, 2018)
Physical activity	3 years	using the Epic Physical Activity Questionnaire (EPAQ2) (Wareham et al., 2002)
Participants motivation to eat healthily	3 years	measured using the Healthy Eating Motivation Score (Naughton et al., 2015)