Clinical trial NCT03151694: Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Chronic Disease
Official title: Foundational Work for a Brain-to-Society Diagnostic for Prevention of Childhood Obesity and Its Chronic Diseases Consequences
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: childhood obesity
body weight
nutritional risk
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: The INCLEN Trust International
First posted: 2017-05-12
Enrollment: 1224
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

Primary outcomes:
measure: Individual-level BtS Diagnostic 1
timeFrame: 2 years
measure: Individual-level BtS Diagnostic 2
timeFrame: 2 years
Secondary outcomes:
measure: Behavioral Assessment
timeFrame: 2 years
measure: Body Weight Assessment
timeFrame: 2 years
measure: Nutritional Risk Assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill Centre for the Convergence of Health and Economics (MCCHE)
state: Quebec
city: New Delhi
country: India
facility: The INCLEN Trust International
Study officials:
affiliation: McGill University
name: Laurette Dubé, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: