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

Primary Purpose

Adiposity, Behavior, Health

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Genotype- based personalised advice
Non genetic personalised advice
Sponsored by
St Mary's University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adiposity

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Age 18-25 years

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Experimental

    Arm Label

    Control

    Non genetic personalised advice

    Genotype- based personalised advice

    Arm Description

    no advice

    dietary and physical activity advice based on reported dietary intake and physical activity

    dietary and physical activity advice based on genotype, reported dietary intake and physical activity

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 16, 2019
    Last Updated
    September 17, 2019
    Sponsor
    St Mary's University College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04096404
    Brief Title
    Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students
    Official Title
    A Longitudinal Study to Determine the Effect of Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2019 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    St Mary's University College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adiposity, Behavior, Health

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    no advice
    Arm Title
    Non genetic personalised advice
    Arm Type
    Active Comparator
    Arm Description
    dietary and physical activity advice based on reported dietary intake and physical activity
    Arm Title
    Genotype- based personalised advice
    Arm Type
    Experimental
    Arm Description
    dietary and physical activity advice based on genotype, reported dietary intake and physical activity
    Intervention Type
    Genetic
    Intervention Name(s)
    Genotype- based personalised advice
    Intervention Description
    Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their genotype via email
    Intervention Type
    Behavioral
    Intervention Name(s)
    Non genetic personalised advice
    Intervention Description
    Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their reported intake, BMI and activity via email
    Primary Outcome Measure Information:
    Title
    Body weight in kg
    Description
    Weight will be measured to the nearest 0.1 kg
    Time Frame
    3 years
    Title
    Body fat percentage
    Description
    Body fat percentage will be measured to the nearest 0.1%
    Time Frame
    3 years
    Title
    Body mass index in Kg/m2
    Description
    calculated from measured height and weight
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Dietary intake
    Description
    using a four day food diary collected using a food diary and nutritional analysis app (Libro, 2018)
    Time Frame
    3 years
    Title
    Physical activity
    Description
    using the Epic Physical Activity Questionnaire (EPAQ2) (Wareham et al., 2002)
    Time Frame
    3 years
    Title
    Participants motivation to eat healthily
    Description
    measured using the Healthy Eating Motivation Score (Naughton et al., 2015)
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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