NCT04096404

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

August 16, 2019

Last Update Submit

September 17, 2019

Conditions

AdiposityBehavior, Health

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Dietary intake

    3 years

  • Physical activity

    3 years

  • Participants motivation to eat healthily

    3 years

Study Arms (3)

Control

NO INTERVENTION

no advice

Non genetic personalised advice

ACTIVE COMPARATOR

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

Behavioral: Non genetic personalised advice

Genotype- based personalised advice

EXPERIMENTAL

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

Genetic: Genotype- based personalised adviceBehavioral: Non genetic personalised advice

Interventions

Genotype- based personalised adviceGENETIC

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

Genotype- based personalised advice
Non genetic personalised adviceBEHAVIORAL

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 adviceNon genetic personalised advice

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-25 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityHealth Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

September 19, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share