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

• Sponsor: St Mary's University College (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04096404
• Collaborator: (none)
• Enrollment: 400
• Arms: 3
• Anticipated Duration (Months): 36

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adiposity; Behavior, Health	Genetic: Genotype- based personalised advice; Behavioral: Non genetic personalised advice	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Longitudinal Study to Determine the Effect of Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students
• Anticipated Study Start Date: Sep 1, 2019
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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	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

Outcome Measures

Primary Outcome Measures

1. Body weight in kg [3 years]

   Weight will be measured to the nearest 0.1 kg

2. Body fat percentage [3 years]

   Body fat percentage will be measured to the nearest 0.1%

3. Body mass index in Kg/m2 [3 years]

   calculated from measured height and weight

Secondary Outcome Measures

1. Dietary intake [3 years]

   using a four day food diary collected using a food diary and nutritional analysis app (Libro, 2018)

2. Physical activity [3 years]

   using the Epic Physical Activity Questionnaire (EPAQ2) (Wareham et al., 2002)

3. Participants motivation to eat healthily [3 years]

   measured using the Healthy Eating Motivation Score (Naughton et al., 2015)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 18-25 years

Exclusion Criteria:

• Pregnancy and lactation

• Chronic disease

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• St Mary's University College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St Mary's University College
• ClinicalTrials.gov Identifier: NCT04096404
• Other Study ID Numbers: SMEC_2018-19_052
• First Posted: Sep 19, 2019
• Last Update Posted: Sep 19, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Sep 19, 2019