Active — Not RecruitingNot Applicable

The Family Stress Study - Chronic Stress and Child Adiposity: Testing a Bio-behavioural Model

Canada300 participantsStarted 2020-07-09

Plain-language summary

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.

Who can participate

Age range

2 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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); * Ch…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Child Body Composition - Waist Circumference

Timeframe: Year 2 (T3)

Child Body Composition - Child BMIz Score

Timeframe: Year 2 (T3)

Trial details

NCT IDNCT05534711

SponsorUniversity of Guelph

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-05-30

View on ClinicalTrials.gov More Pediatric Obesity trials