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

NCT05534711 | Active Not Recruiting

• 1 other identifier: FSS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pediatric Obesity; Mental Health Wellness 1

Keywords

Chronic stress; Child obesity; Household chaos; Parental depression; COVID19; Child mental health

Outcome Measures

Primary Outcomes (2)

• Child Body Composition - Waist Circumference

  Child waist circumference in cm

  Year 2 (T3)

• Child Body Composition - Child BMIz Score

  Child BMIz score in kg/m2 - combined weight height, age, sex

  Year 2 (T3)

Secondary Outcomes (1)

• Mental health in children

  Year 5 (T4)

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Family: For this study, we define family as caregivers and their oldest eligible child who is 2-6 years old. Families can have one or many caregivers. Up to two caregivers from each family can register to take part in this study; Caregiver(s): We define caregivers as the main adults who regularly provide direct care for children of a family. Examples of caregivers include parents (can be biological, related, adoptive or foster if living with the child full time), grandparents, aunts and uncles. One participating caregiver must have at least 50% custody or 50% legal guardianship of the oldest eligible child who is 2-6 years old.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guelph: lead
• McMaster University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (1)

• Pare SM, Gunn E, Morrison KM, Miller AL, Duncan AM, Buchholz AC, Ma DWL, Tremblay PF, Vallis LA, Mercer NJ, Haines J. Testing a Biobehavioral Model of Chronic Stress and Weight Gain in Young Children (Family Stress Study): Protocol and Baseline Demographics for a Prospective Observational Study. JMIR Res Protoc. 2024 Jun 20;13:e48549. doi: 10.2196/48549.

  PMID: 38900565 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; COVID-19

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jess Haines, PhD

  University of Guelph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jess Haines

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: September 9, 2022
• Study Start: July 9, 2020
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CA (2)