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

• Conditions: Obesity

• Registration Number: NCT03151694
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-01
• Status Verified: 2017-04
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-11
• Last Update Submitted: 2017-05-11
• Study First Posted: 2017-05-12
• Last Update Posted: 2017-05-12
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1224

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Individual-level BtS Diagnostic 1	2 years	Genotyping and detection of the Taq1A allele in the dopamine-2 receptor (DRD2) gene.
Individual-level BtS Diagnostic 2	2 years	Genotyping and detection of the exon 3 7-repeat allele of the dopamine-4 receptor (DRD4) gene.

Secondary Outcome Measures

Name	Time	Method
Behavioral Assessment	2 years	Assess behavior of each participant in relation to food choice
Nutritional Risk Assessment	2 years	Assess nutrition intake for each participant.
Body Weight Assessment	2 years	Assess body weight of each participant

Trial Locations

Locations (2)

The INCLEN Trust International; 🇮🇳 New Delhi, India

McGill Centre for the Convergence of Health and Economics (MCCHE); 🇨🇦 Montréal, Quebec, Canada