Child Eating BehavioursNCT06389084
Parents Together: Supporting Parents to Promote Healthy Behaviours in Children
A study testing Parents Together parenting course in people with Child Eating Behaviours and Child Nutrition, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
The Parents Together trial aims to determine if the Parents Together program consisting of virtual parent group sessions and coaching calls, will result in better health outcomes for children. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Eating Behaviours, Child Nutrition, Early Child Development
- What is being tested?
- Parents Together parenting course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child enrolled in the The Applied Reearch Group for Kids (TARGet Kids!) cohort study Family is able to participate in English
Who cannot join
- Children with a sibling already enrolled in the study Children with severe developmental delay or disability
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
St. Michaels Hospital Pediatric Outpatient Clinic
Toronto, Ontario
Jonathon Maguire, 416-867-3655, jonathon.maguire@unityhealth.to
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
Catherine Birken, MD, (416) 813-1500, cbirken@sickkids.ca
About this study
The Parents Together trial aims to determine if the Parents Together program consisting of virtual parent group sessions and coaching calls, will result in better health outcomes for children. The program which is facilitated by a Public Health Nurse seeks to encourage healthy lifestyle behaviours, help build strong family relationships, and promote child development and mental health.
Read the detailed description
This study will determine whether an intervention combining group-based parenting skills training and public health nurse coaching calls with a focus on healthy eating behaviours and nutrition, activity and sleep, compared to regular health care will lead to improved eating behaviours, movement behaviours, health and mental health in children aged 2-5 years and their caregivers.
Healthy children will be identified through primary care practices participating in The Applied Reearch Group for Kids (TARGet Kids!). Families who participate in this study will be randomly assigned to one of the two study groups that will run for 6-months:
Group A: Receive 8 weeks of group parenting education sessions and up to 4 public health nurse coaching calls. Group B: Receive regular health care.
- Being tested
- Parents Together parenting course
- Keywords
- child eating behaviours, child nutrition, parenting, early child development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents Together parenting courseBehavioural
parenting course and coaching calls
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | Experimental | One or two caregivers of each enrolled child will attend an 8-week virtual parent/caregiver education program delivered by a Public Health Nurse. Additionally, the Public Health Nurse will deliver up to 4 individual coaching calls designed to address participant-identified goals related to the group content. The coaching calls will focus on helping to apply the messages and skills from the group sessions and making community connections. Receives: Behavioral: Parents Together parenting course |
| Control | No intervention | Participants randomized to the control group receive regular health care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child eating behaviours
Child Eating Behaviour Questionnaire (CEBQ)
Measured: 6 months post-randomization
Secondary outcomes (13)
Dietary intake and food environment
Parent reported measures of dietary intake, and food environment (based on the Canadian Community Health Survey)
Measured: 6 months post-randomization
Nutritional risk
Nutrition Screeening Tool for Every Preschooler (NutriSTEP)
Measured: 6 months post-randomization
Physical Activity, Sedentary Time, Sleep Duration
Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey)
Measured: 6 months post-randomization
Physical activity
Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey)
Measured: 6 months post-randomization
Social and emotional development
Strengths and Difficulty Questionnaire (SDQ)
Measured: 6 months post-randomization
Child development
Ages and Stages Questionnaire-3 (ASQ-3)
Measured: 6 months post-randomization
Family psychosocial health
Parenting Stress Index (PSI) and Patient Health Questionnaire (PHQ-9)
Measured: 6 months post-randomization
Parenting
Parenting Scale
Measured: 6 months post-randomization
Parenting sense of competence
Parenting Sense of Competency Scale-Revised (PSOC-R
Measured: 6 months post-randomization
sociodemographic, maternal and child characteristics
parent self-reported income, maternal education, ethnicity, immigration status, and marital status, questions about parents health, exposures during pregnancy, family medical history (based on the Canadian Community Health Survey)
Measured: 6 months post-randomization
zBMI
Measure the difference in age and sex-standardized BMI z-score (zBMI) using child height and weight
Measured: 6 months post-randomization
Waist circumference
Measure waist circumference using a tape measure
Measured: 6 months post-randomization
Blood pressure
Measurement of diastolic and systolic blood pressure in children
Measurement of diastolic and systolic blood pressure in children
Measurement of diastolic and systolic blood pressure in children
Measurement of diastolic and systolic blood pressure in children
Measured: 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Jun 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Eating BehavioursStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Birken, The Hospital for Sick Children
- Investigators
- Catherine Birken, MD, MSc, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389084
- Sponsor's protocol ID
- 179939
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents Together: Supporting Parents to Promote Healthy Behaviours in Children
- ClinicalTrials.gov ID
- NCT06389084
- Acronym / sponsor ID
- 179939
- Keywords
- child eating behaviours, child nutrition, parenting, early child development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Apr 2024 (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 Parents Together trial aims to determine if the Parents Together program consisting of virtual parent group sessions and coaching calls, will result in better health outcomes for children. The program which is facilitated by a Public Health Nurse seeks to encourage healthy lifestyle behaviours, help build strong family relationships, and promote child development and mental health.
Detailed description
This study will determine whether an intervention combining group-based parenting skills training and public health nurse coaching calls with a focus on healthy eating behaviours and nutrition, activity and sleep, compared to regular health care will lead to improved eating behaviours, movement behaviours, health and mental health in children aged 2-5 years and their caregivers.
Healthy children will be identified through primary care practices participating in The Applied Reearch Group for Kids (TARGet Kids!). Families who participate in this study will be randomly assigned to one of the two study groups that will run for 6-months:
Group A: Receive 8 weeks of group parenting education sessions and up to 4 public health nurse coaching calls. Group B: Receive regular health care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Behavioral: Parents Together parenting courseOne or two caregivers of each enrolled child will attend an 8-week virtual parent/caregiver education program delivered by a Public Health Nurse. Additionally, the Public Health Nurse will deliver up to 4 individual coaching calls designed to address participant-identified goals related to the group content. The coaching calls will focus on helping to apply the messages and skills from the group sessions and making community connections. |
| Control | No intervention | –Participants randomized to the control group receive regular health care. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child enrolled in the The Applied Reearch Group for Kids (TARGet Kids!) cohort study Family is able to participate in English
Key exclusion criteria (1 listed)
- Children with a sibling already enrolled in the study Children with severe developmental delay or disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parents Together parenting courseparenting course and coaching calls | Behavioural | Intervention/treatment |
Primary outcome
Child eating behaviours
Time frame: 6 months post-randomization
Child Eating Behaviour Questionnaire (CEBQ)
13 secondary outcomes
Dietary intake and food environment
Time frame: 6 months post-randomization
Nutritional risk
Time frame: 6 months post-randomization
Physical Activity, Sedentary Time, Sleep Duration
Time frame: 6 months post-randomization
Physical activity
Time frame: 6 months post-randomization
Social and emotional development
Time frame: 6 months post-randomization
Child development
Time frame: 6 months post-randomization
Family psychosocial health
Time frame: 6 months post-randomization
Parenting
Time frame: 6 months post-randomization
Parenting sense of competence
Time frame: 6 months post-randomization
sociodemographic, maternal and child characteristics
Time frame: 6 months post-randomization
zBMI
Time frame: 6 months post-randomization
Waist circumference
Time frame: 6 months post-randomization
Blood pressure
Time frame: 6 months post-randomization
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 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Catherine Birken, MD, MSc principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents Together parenting course in people with Child Eating Behaviours and Child Nutrition, run by The Hospital for Sick Children 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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?
Contact Catherine Birken, MD, MSc (416-813-7654 ext. 301544, catherine.birken@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child eating behaviours (time frame: 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.