AdiposityNCT04096404
Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students
A study testing Genotype- based personalised advice and Non genetic personalised advice in people with Adiposity and Behavior, Health, run by St Mary's University College.
Trial summary
A longitudinal study to determine the effect of gene-based personalised diet and physical activity advice on adiposity indices in university students. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Adiposity, Behavior, Health
- What is being tested?
- Genotype- based personalised advice and Non genetic personalised advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-25 years
Who cannot join
- Pregnancy and lactation
- Chronic disease
- A history of disordered eating and following a restricted diet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adiposity, Behavior, Health
- Being tested
- Genotype- based personalised advice, Non genetic personalised advice
- Medical subject headings
- Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotype- based personalised adviceGenetic
Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their genotype via email
Non genetic personalised adviceBehavioural
Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their reported intake, BMI and activity via email
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | no advice |
| Non genetic personalised advice | Active comparator | dietary and physical activity advice based on reported dietary intake and physical activity Receives: Behavioral: Non genetic personalised advice |
| Genotype- based personalised advice | Experimental | dietary and physical activity advice based on genotype, reported dietary intake and physical activity Receives: Genetic: Genotype- based personalised advice; Behavioral: Non genetic personalised advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight in kg
Weight will be measured to the nearest 0.1 kg
Measured: 3 years
Body fat percentage
Body fat percentage will be measured to the nearest 0.1%
Measured: 3 years
Body mass index in Kg/m2
calculated from measured height and weight
Measured: 3 years
Secondary outcomes (3)
Dietary intake
using a four day food diary collected using a food diary and nutritional analysis app (Libro, 2018)
Measured: 3 years
Physical activity
using the Epic Physical Activity Questionnaire (EPAQ2) (Wareham et al., 2002)
Measured: 3 years
Participants motivation to eat healthily
measured using the Healthy Eating Motivation Score (Naughton et al., 2015)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096404
- Sponsor's protocol ID
- SMEC_2018-19_052
- Status last verified
- Sep 2019
- First submitted
- 16 Aug 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study to Determine the Effect of Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students
- ClinicalTrials.gov ID
- NCT04096404
- Acronym / sponsor ID
- SMEC_2018-19_052
- Conditions
- Adiposity, Behavior, Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –no advice |
| Non genetic personalised advice | Active comparator | Behavioral: Non genetic personalised advicedietary and physical activity advice based on reported dietary intake and physical activity |
| Genotype- based personalised advice | Experimental | Genetic: Genotype- based personalised advice, Behavioral: Non genetic personalised advicedietary and physical activity advice based on genotype, reported dietary intake and physical activity |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-25 years
Key exclusion criteria (3 listed)
- Pregnancy and lactation
- Chronic disease
- A history of disordered eating and following a restricted diet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genotype- based personalised adviceFollowing allocation to groups participants will receive appropriate dietary and physical activity advice based on their genotype via email | Genetic | Genotype- based personalised advice |
| Non genetic personalised adviceFollowing allocation to groups participants will receive appropriate dietary and physical activity advice based on their reported intake, BMI and activity via email | Behavioural | Genotype- based personalised advice, Non genetic personalised advice |
Primary outcome
Body weight in kg
Time frame: 3 years
Weight will be measured to the nearest 0.1 kg
Body fat percentage
Time frame: 3 years
Body fat percentage will be measured to the nearest 0.1%
Body mass index in Kg/m2
Time frame: 3 years
calculated from measured height and weight
3 secondary outcomes
Dietary intake
Time frame: 3 years
Physical activity
Time frame: 3 years
Participants motivation to eat healthily
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Genotype- based personalised advice and Non genetic personalised advice in people with Adiposity and Behavior, Health, run by St Mary's University College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight in kg (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.