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

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: Unknown
• Conditions: Obesity

• Study Type: Observational
• Enrollment (Actual): 1224

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: The INCLEN Trust International
• Investigators: Principal Investigator: Laurette Dubé, Ph.D., McGill University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): January 31, 2019

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: childhood obesity; body weight; nutritional risk
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Chronic Disease
• Other Study ID 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