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

September 5, 2022 updated by: Jess Haines, University of Guelph

Family Stress Study: A Longitudinal Observational Study Examining Chronic Stress and Weight Gain Pathways in Young Children.

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.

Study Overview

Status

Active, not recruiting

Detailed Description

The Family Stress Study is a longitudinal observational study designed to examine behavioural and biological pathways through which exposure to chronic stress may impact excess weight gain in young children.

This study will examine whether exposure to chronic stressors, i.e., household chaos, negative life events, food insecurity, and parental depression, is directly associated with higher weight gain among children. This study will also examine whether alterations in children's cortisol production and weight-related behaviours, i.e., dietary intake, eating behaviour, physical activity, sedentary behaviours and sleep, mediate the stress-weight gain link in young children. This research will also identify whether the quality of caregiver relationships, child sex, family social support, family social connection, or caregiver education moderate the pathways linking stress and excess weight gain.

To achieve our aims, 300 children aged 2 to 6 years from families in the Guelph and Hamilton areas will be recruited to examine key behavioural and biological pathways through which exposure to chronic stress may impact weight gain. Our study will also examine the impact of chronic stress on children's mental health, which is a secondary outcome of our study. Understanding which sources of stress and the key behaviours that have the greatest impact on obesity risk among chronically stressed children will aid in the development of effective obesity prevention interventions for specific families.

Additionally, this study is well-poised to examine how family stressors during the COVID-19 pandemic influenced children's health behaviours and resulting weight outcomes. Further examination of COVID-19-related stressors, i.e., quarantine or illness due to COVID-19, employment in essential services, general stress, food insecurity, financial insecurity and employment change due to COVID-19, impact cortisol levels and health behaviours and resulting weight outcomes in children. We will also examine how factors such as family social connection or social support, may moderate the impact of the stressors due to COVID-19 on child health. This information will guide strategies to support families in the post-COVID-19 context.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Guelph, Ontario, Canada, N1G 2W1
        • University of Guelph
      • Hamilton, Ontario, Canada, L8S 4L8
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Body Composition - Waist Circumference
Time Frame: Year 2 (T3)
Child waist circumference in cm
Year 2 (T3)
Child Body Composition - Child BMIz Score
Time Frame: Year 2 (T3)
Child BMIz score in kg/m2 - combined weight height, age, sex
Year 2 (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2020

Primary Completion (ANTICIPATED)

May 30, 2024

Study Completion (ANTICIPATED)

May 30, 2024

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (ACTUAL)

September 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Obesity

3
Subscribe