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

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

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

Study Overview

• Status: Unknown
• Conditions: Adiposity; Behavior, Health
• Intervention / Treatment: Behavioral: Non genetic personalised advice; Genetic: Genotype- based personalised advice

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-25 years

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; no advice
Active Comparator: Non genetic personalised advice; dietary and physical activity advice based on reported dietary intake and physical activity	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
Experimental: Genotype- based personalised advice; dietary and physical activity advice based on genotype, reported dietary intake and physical activity	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; Genetic: Genotype- based personalised advice; Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their genotype via email

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St Mary's University College

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: SMEC_2018-19_052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No