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

Adiposity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04096404
• Other study ID #: SMEC_2018-19_052
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: September 2022

Study information

• Verified date: September 2019
• Source: St Mary's University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Age 18-25 years

Exclusion Criteria:

• Pregnancy and lactation

• Chronic disease

• A history of disordered eating and following a restricted diet.

Related Conditions & MeSH terms

• Adiposity
• Behavior, Health
• Obesity

Intervention

Genetic:
• Genotype- based personalised advice
Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their genotype via email

Behavioral:
• Non genetic personalised advice
Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their reported intake, BMI and activity via email

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St Mary's University College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight in kg	Weight will be measured to the nearest 0.1 kg	3 years
Primary	Body fat percentage	Body fat percentage will be measured to the nearest 0.1%	3 years
Primary	Body mass index in Kg/m2	calculated from measured height and weight	3 years
Secondary	Dietary intake	using a four day food diary collected using a food diary and nutritional analysis app (Libro, 2018)	3 years
Secondary	Physical activity	using the Epic Physical Activity Questionnaire (EPAQ2) (Wareham et al., 2002)	3 years
Secondary	Participants motivation to eat healthily	measured using the Healthy Eating Motivation Score (Naughton et al., 2015)	3 years