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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03151694
Other study ID # 227856
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 2, 2017
Last updated May 11, 2017
Start date February 1, 2011
Est. completion date January 31, 2019

Study information

Verified date April 2017
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1224
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada McGill Centre for the Convergence of Health and Economics (MCCHE) Montréal Quebec
India The INCLEN Trust International New Delhi

Sponsors (2)

Lead Sponsor Collaborator
McGill University The INCLEN Trust International

Countries where clinical trial is conducted

Canada,  India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Individual-level BtS Diagnostic 1 Genotyping and detection of the Taq1A allele in the dopamine-2 receptor (DRD2) gene. 2 years
Primary Individual-level BtS Diagnostic 2 Genotyping and detection of the exon 3 7-repeat allele of the dopamine-4 receptor (DRD4) gene. 2 years
Secondary Behavioral Assessment Assess behavior of each participant in relation to food choice 2 years
Secondary Body Weight Assessment Assess body weight of each participant 2 years
Secondary Nutritional Risk Assessment Assess nutrition intake for each participant. 2 years
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