Clinical trial
The Family Stress Study - Chronic Stress and Child Adiposity: Testing a Bio-behavioural Model
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05534711
Active, not recruitingNot applicableObservational
What this study is about
The Family Stress Study is following families with young children in Guelph, Hamilton and surrounding areas over 3 years to understand how chronic stress impacts children's weight gain over time and how this association is mediated by alterations in children's cortisol production and weight-related behaviours.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age2 Years to 6 Years
SexAll
Healthy volunteersAccepted
ConditionPediatric Obesity, Mental Health Wellness 1
Full registry criteria
Inclusion Criteria: * Families are eligible to participate if they have at least 1 adult caregiver responsible for the care of a child aged 2-6 years at the time of enrollment (target age group for the study); * Families must live in the Guelph (i.e.: Wellington County- includes Guelph, Rockwood, Fergus, Elora, Mount Forest, Puslinch, Cambridge, Kitchener, Waterloo) or Hamilton (i.e.: Municipality of Hamilton-Wentworth - includes Hamilton, Ancaster, Dundas, Flamborough, Glanbrook, Stoney Creek as well as Burlington) areas and must not be planning to move outside of these areas within three years; Exclusion Criteria: * Language - The participating caregiver must be fluent in English since all study communications and survey questions are in English; * Participation in the Guelph Family Health Study (GFHS) - families previously or currently participating in the GFHS will be excluded as the GFHS provided intervention that may bias the results of the current study; * Child custody - The participating caregiver must have at least 50% shared custody of their child (to allow for separated/divorced families to participate ensuring caregivers' reports of family-level stressors are relevant for the child); * Health conditions of the children impacting cortisol production, obesity and/or growth/body composition - Hair sample cortisol, fat mass and growth measurements would be affected by these conditions (e.g. Cushing's Disease, Prader Willi Syndrome, untreated thyroid disease); * Children taking steroid medications including oral or inhaled corticosteroids - Hair sample cortisol measurements would be affected by the use of steroid medications; * Children taking medications for ADHD (attention deficit hyperactivity disorder), antidepressants or antipsychotic medications - These medications can affect body composition; * Children born before 34 weeks gestation - Body composition and growth can be affected for children born before 34 weeks.
Treatments and study arms
The registry does not list a named intervention.
Primary outcomes
Child Body Composition - Waist CircumferenceYear 2 (T3)
Child waist circumference in cm
Child Body Composition - Child BMIz ScoreYear 2 (T3)
Child BMIz score in kg/m2 - combined weight height, age, sex