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

Obesity Clinical Trial

Official title:

Foundational Work for a Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Its Chronic Diseases Consequences

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03151694
• Other study ID #: 227856
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Disease
• Obesity
• Pediatric Obesity

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