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

NCT ID: NCT04096404

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2022-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Adiposity Behavior, Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

no advice

Group Type NO_INTERVENTION

No interventions assigned to this group

Non genetic personalised advice

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

Group Type ACTIVE_COMPARATOR

Non genetic personalised advice

Intervention Type BEHAVIORAL

Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their reported intake, BMI and activity via email

Genotype- based personalised advice

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

Group Type EXPERIMENTAL

Genotype- based personalised advice

Intervention Type GENETIC

Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their genotype via email

Non genetic personalised advice

Intervention Type BEHAVIORAL

Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their reported intake, BMI and activity via email

Interventions

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Genotype- based personalised advice

Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their genotype via email

Intervention Type GENETIC

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

• Age 18-25 years

Exclusion Criteria

* Pregnancy and lactation
* Chronic disease
* A history of disordered eating and following a restricted diet.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St Mary's University College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SMEC_2018-19_052

Identifier Type: -

Identifier Source: org_study_id

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