ObesityNCT03151694
Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Chronic Disease
An observational study of Obesity, run by McGill University at 2 sites in 2 countries.
Trial summary
This multi-national program applies a breakthrough approach to childhood obesity called, Brain-to-Society (BtS) Diagnostic Approach. In Montreal, Canada and Palwal, India, the investigators will recruit two cohorts of 612 children (6 to 12 years; 306 boy/306 girls) where Whole-of-Society (WoS) transformations are… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 1,224 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2011to 31 Jan 2019
- Phase
- Observational
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: In two field settings, Canada (Montreal) and India (Palwal), two cohorts of 612 children (6 to 12 years; 306 boy/306 girls) were recruited. Only one child per family was recruited.
Who may be able to join
- Sample population that are exposed to multi-level Whole-of-Society transformation (i.e., Quebec Governmental Action Plan (PAG) and World Health Assembly (WHA) resolution for Quebec sample; Intense Urbanization and Industrialization (IUI) and WHA resolution in India).
Who cannot join
- first cousin relations were excluded from the sample population.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
McGill Centre for the Convergence of Health and Economics (MCCHE)
Montreal, Quebec, H3A 1X9
About this study
Official title: Foundational Work for a Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Its Chronic Diseases Consequences
This multi-national program applies a breakthrough approach to childhood obesity called, Brain-to-Society (BtS) Diagnostic Approach. In Montreal, Canada and Palwal, India, the investigators will recruit two cohorts of 612 children (6 to 12 years; 306 boy/306 girls) where Whole-of-Society (WoS) transformations are taking place (industrialized societal context with peaking childhood obesity and where a broad governmental plan to promote healthy lifestyle has been adopted -Canada; developing societal context with increasing childhood obesity if replication of past pathways that have lead to double burden; India) are taking place along with World Health Assembly (WHA) resolution A63-12 for marketing of food to children. Individual-level BtS Diagnostic will examine the degree to which individual differences in genetics and biology and differences in the environmental exposures modulate the behavioral, body weight/fatness and nutritional risk over time in the context of WoS transformations. Societal-level BtS Diagnostic shall examine the influence of decisions in policy, investment, business and innovation made by different stakeholders (government, private sector, civil society in health and non-health society systems including agriculture, business and media practices) on the community.
- Conditions
- Obesity
- Keywords
- childhood obesity, body weight, nutritional risk
- Medical subject headings
- Obesity, Pediatric Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DRD4 and DRD2 Polymorphism Detection | The genetic component of endophenotype for responsiveness to environment (ERE) will be characterized with reference to Taq1A allele in dopamine-2 receptor (DRD2) gene and the exon 3 7-repeat allele of the dopamine-4 receptor (DRD4) gene. This will assist in understanding the role of DRD2 and DRD4 in shaping the neurocognitive functions and link to the eating behaviors of the children and other primary outcome variables. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual-level BtS Diagnostic 1
Genotyping and detection of the Taq1A allele in the dopamine-2 receptor (DRD2) gene.
Measured: 2 years
Individual-level BtS Diagnostic 2
Genotyping and detection of the exon 3 7-repeat allele of the dopamine-4 receptor (DRD4) gene.
Measured: 2 years
Secondary outcomes (3)
Behavioral Assessment
Assess behavior of each participant in relation to food choice
Measured: 2 years
Body Weight Assessment
Assess body weight of each participant
Measured: 2 years
Nutritional Risk Assessment
Assess nutrition intake for each participant.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Feb 2011
- Primary completion31 Jan 2019 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,224 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- The INCLEN Trust International
- Responsible party
- Sponsor
- Investigators
- Laurette Dubé, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151694
- Sponsor's protocol ID
- 227856
- Status last verified
- Apr 2017
- First submitted
- 2 May 2017
- Last updated
- 12 May 2017
- 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 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foundational Work for a Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Its Chronic Diseases Consequences
- ClinicalTrials.gov ID
- NCT03151694
- Acronym / sponsor ID
- 227856
- Conditions
- Obesity
- Keywords
- childhood obesity, body weight, nutritional risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,224 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- The INCLEN Trust International
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 12 May 2017 (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.
This multi-national program applies a breakthrough approach to childhood obesity called, Brain-to-Society (BtS) Diagnostic Approach. In Montreal, Canada and Palwal, India, the investigators will recruit two cohorts of 612 children (6 to 12 years; 306 boy/306 girls) where Whole-of-Society (WoS) transformations are taking place (industrialized societal context with peaking childhood obesity and where a broad governmental plan to promote healthy lifestyle has been adopted -Canada; developing societal context with increasing childhood obesity if replication of past pathways that have lead to double burden; India) are taking place along with World Health Assembly (WHA) resolution A63-12 for marketing of food to children. Individual-level BtS Diagnostic will examine the degree to which individual differences in genetics and biology and differences in the environmental exposures modulate the behavioral, body weight/fatness and nutritional risk over time in the context of WoS transformations. Societal-level BtS Diagnostic shall examine the influence of decisions in policy, investment, business and innovation made by different stakeholders (government, private sector, civil society in health and non-health society systems including agriculture, business and media practices) on the community.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRD4 and DRD2 Polymorphism Detection | – | –The genetic component of endophenotype for responsiveness to environment (ERE) will be characterized with reference to Taq1A allele in dopamine-2 receptor (DRD2) gene and the exon 3 7-repeat allele of the dopamine-4 receptor (DRD4) gene. This will assist in understanding the role of DRD2 and DRD4 in shaping the neurocognitive functions and link to the eating behaviors of the children and other primary outcome variables. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- In two field settings, Canada (Montreal) and India (Palwal), two cohorts of 612 children (6 to 12 years; 306 boy/306 girls) were recruited. Only one child per family was recruited.
Key inclusion criteria (1 listed)
- Sample population that are exposed to multi-level Whole-of-Society transformation (i.e., Quebec Governmental Action Plan (PAG) and World Health Assembly (WHA) resolution for Quebec sample; Intense Urbanization and Industrialization (IUI) and WHA resolution in India).
Key exclusion criteria (1 listed)
- first cousin relations were excluded from the sample population.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Individual-level BtS Diagnostic 1
Time frame: 2 years
Genotyping and detection of the Taq1A allele in the dopamine-2 receptor (DRD2) gene.
Individual-level BtS Diagnostic 2
Time frame: 2 years
Genotyping and detection of the exon 3 7-repeat allele of the dopamine-4 receptor (DRD4) gene.
3 secondary outcomes
Behavioral Assessment
Time frame: 2 years
Body Weight Assessment
Time frame: 2 years
Nutritional Risk Assessment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- 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.
Laurette Dubé, Ph.D. principal investigator
McGill University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by McGill University at 2 sites in 2 countries.
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 1 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Individual-level BtS Diagnostic 1 (time frame: 2 years). The study lists 2 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 12 May 2017.