Pediatric ObesityNCT05534711
The Family Stress Study - Chronic Stress and Child Adiposity: Testing a Bio-behavioural Model
An observational study of Pediatric Obesity and Mental Health Wellness 1, run by University of Guelph at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Mental Health Wellness 1
- How many people
- 300 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Jul 2020to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Guelph
Guelph, Ontario, N1G 2W1
McMaster University
Hamilton, Ontario, L8S 4L8
About this study
Official title: 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.
Read the 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, 360 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.
- Conditions
- Pediatric Obesity, Mental Health Wellness 1
- Keywords
- Chronic stress, Child obesity, Household chaos, Parental depression, COVID19, Child mental health
- Medical subject headings
- Pediatric Obesity, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Body Composition - Waist Circumference
Child waist circumference in cm
Measured: Year 2 (T3)
Child Body Composition - Child BMIz Score
Child BMIz score in kg/m2 - combined weight height, age, sex
Measured: Year 2 (T3)
Secondary outcomes (1)
Mental health in children
Mental health outcomes in children using survey measures of stress, adverse life events, and psychosocial problems.
Measured: Year 5 (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start9 Jul 2020
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jess Haines, University of Guelph
- Investigators
- Jess Haines, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534711
- Sponsor's protocol ID
- FSS
- Status last verified
- Apr 2026
- First submitted
- 15 Jul 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38900565
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Stress Study: A Longitudinal Observational Study Examining Chronic Stress and Weight Gain Pathways in Young Children.
- ClinicalTrials.gov ID
- NCT05534711
- Acronym / sponsor ID
- FSS
- Conditions
- Pediatric Obesity, Mental Health Wellness 1
- Keywords
- Chronic stress, Child obesity, Household chaos, Parental depression, COVID19, Child mental health
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- McMaster University, Canadian Institutes of Health Research (CIHR)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 360 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child Body Composition - Waist Circumference
Time frame: Year 2 (T3)
Child waist circumference in cm
Child Body Composition - Child BMIz Score
Time frame: Year 2 (T3)
Child BMIz score in kg/m2 - combined weight height, age, sex
1 secondary outcome
Mental health in children
Time frame: Year 5 (T4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 38900565Pare 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jess Haines, PhD principal investigator
University of Guelph
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity and Mental Health Wellness 1, run by University of Guelph at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Body Composition - Waist Circumference (time frame: Year 2 (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.