Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Chronic Disease

May 11, 2017 updated by: McGill University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3A 1X9
        • McGill Centre for the Convergence of Health and Economics (MCCHE)
  • India
      • New Delhi, India, 110020
        • The INCLEN Trust International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • first cousin relations were excluded from the sample population.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Individual-level BtS Diagnostic 1
Time Frame: 2 years
Genotyping and detection of the Taq1A allele in the dopamine-2 receptor (DRD2) gene.
2 years
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavioral Assessment
Time Frame: 2 years
Assess behavior of each participant in relation to food choice
2 years
Body Weight Assessment
Time Frame: 2 years
Assess body weight of each participant
2 years
Nutritional Risk Assessment
Time Frame: 2 years
Assess nutrition intake for each participant.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The INCLEN Trust International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurette Dubé, Ph.D., McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 227856

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Peer-Reviewed Article

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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