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

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ClinicalTrials.gov Identifier: NCT03151694
Recruitment Status : Unknown
Verified April 2017 by McGill University.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
The INCLEN Trust International
Information provided by (Responsible Party):
McGill University

Brief 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 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.

Condition or disease
Obesity

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Study Type : Observational
Actual Enrollment : 1224 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Foundational Work for a Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Its Chronic Diseases Consequences
Actual Study Start Date : February 1, 2011
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Individual-level BtS Diagnostic 1 [ Time Frame: 2 years ]
    Genotyping and detection of the Taq1A allele in the dopamine-2 receptor (DRD2) gene.

  2. 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.


Secondary Outcome Measures :
  1. Behavioral Assessment [ Time Frame: 2 years ]
    Assess behavior of each participant in relation to food choice

  2. Body Weight Assessment [ Time Frame: 2 years ]
    Assess body weight of each participant

  3. Nutritional Risk Assessment [ Time Frame: 2 years ]
    Assess nutrition intake for each participant.


Biospecimen Retention:   Samples With DNA
DNA saliva samples were collected for healthy participants between the ages of 6 and 12 years old before proceeding with genotyping of the 7-repeat risk allele on dopamine-4 receptor (DRD4) gene.


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151694


Locations
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Canada, Quebec
McGill Centre for the Convergence of Health and Economics (MCCHE)
Montréal, Quebec, Canada, H3A 1X9
India
The INCLEN Trust International
New Delhi, India, 110020
Sponsors and Collaborators
McGill University
The INCLEN Trust International
Investigators
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Principal Investigator: Laurette Dubé, Ph.D. McGill University

Study Data/Documents: Peer-Reviewed Article  This link exits the ClinicalTrials.gov site

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Responsible Party: McGill University
ClinicalTrials.gov Identifier: NCT03151694     History of Changes
Other Study ID Numbers: 227856
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McGill University:
childhood obesity
body weight
nutritional risk
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Chronic Disease
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Disease Attributes
Pathologic Processes