Preventing and Addressing At-obesity-Risk Early Years INtervention with Home Visits in Toronto (PARENT): a Pragmatic RCT (PARENT)

December 12, 2024 updated by: Catherine Birken, The Hospital for Sick Children
The PARENT Trial aims to determine if the Parents Together program consisting of parent workshops, home visits 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, help build strong family relationships, and promote child mental health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will determine whether a primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, compared to regular health care will lead to improved weight status in 18 months- 4 year old children.

Healthy children at risk for obesity will be identified through primary care practices participating in TARGet Kids!. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6-months:

Group A: Receive 8 weeks of group parenting education sessions, 2 additional group sessions, with 2-4 public health nurse home/virtual visits Group B: Receive regular health care

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital
      • Toronto, Ontario, Canada, M5G 0A4
        • The Hospital for Sick Children

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 4 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children at risk for childhood obesity (meeting any of the risk factors below):
  • birth weight greater than 3500g
  • weight gain in first year of life (crossing of at least 1 percentile line of weight for age or weight for length percentile)
  • maternal or paternal obesity,
  • gestational smoking at birth
  • low median household self-reported income
  • availability of at least one caregiver to participate in trial

Exclusion Criteria:

  • Young children with Prader-Willi syndrome or severe developmental delays
  • obesity or severe obesity (defined as zBMI >2 for all ages)
  • families not fluent in English
  • children with a sibling already enrolled in the study
  • families who reside beyond the Toronto Public Health catchment areas

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Parenting education program

8 weeks of group parenting education sessions followed by two optional booster sessions.

2 public health nurse home/virtual visits and 4 coaching calls over a period of 6 months.
Behavioral: Parenting education program
8-week parent/caregiver education program, followed by two booster sessions. You and/or your partner will attend weekly parenting sessions which will take place either at the office of your child's primary care provider or virtually. Our Toronto Public Health Nurse, will arrange 2 home visits/virtual visits with you and your family along with 4 coaching calls during the 6 months. This first home visit will include learning more about your routines at home, and what is available in your neighbourhood. The home visits will focus on helping to apply the messages and skills from the group sessions for your family, and making connections in your community that you find helpful such as recreational or nutrition programs or other supports for your family.
No Intervention: Control
Receive regular health care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
zBMI
Time Frame: at 6 months and 12 months post-randomization
Measure the difference in age and sex-standardized BMI z-score (zBMI)
at 6 months and 12 months post-randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mental health
Time Frame: at 6 months and 12 months post-randomization
Assess mental health by Strengths and Difficulties Questionnaire
at 6 months and 12 months post-randomization
Eating behaviour and dietary intake
Time Frame: at 6 months and 12 months post-randomization
Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)
at 6 months and 12 months post-randomization
ZBMI
Time Frame: at 6 months and 12 months post-randomization
Measure the difference in age and sex-standardized BMI z-score (zBMI)
at 6 months and 12 months post-randomization
Physical Activity, Sedentary Time, Sleep Duration
Time Frame: at 6 months and 12 months post-randomization
Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey),
at 6 months and 12 months post-randomization
Physical Activity
Time Frame: At 12 months post-randomization
Direct measures of physical activity using accelerometry
At 12 months post-randomization
Psychosocial Health
Time Frame: at 6 months and 12 months post-randomization
family psychosocial health (using the Parental Stress Index)
at 6 months and 12 months post-randomization
Maternal Mental Health
Time Frame: at 6 months and 12 months post-randomization
maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire)
at 6 months and 12 months post-randomization
Parenting
Time Frame: at 6 months and 12 months post-randomization
Parenting (using the Parenting Scale)
at 6 months and 12 months post-randomization
sociodemographic, maternal and child characteristics
Time Frame: at 6 months and 12 months post-randomization
parent self-reported income, maternal education, ethnicity, immigration status, and marital status, questions about parents health, exposures during pregnancy, family medical history - captured by the Nutrition and Health Questionnaire (NHQ).
at 6 months and 12 months post-randomization
Waist circumference
Time Frame: 6 and 12 months post randomization
measured waist circumference using a tape measure
6 and 12 months post randomization
blood pressure
Time Frame: 6 and 12 months post-randomization
measurement of diastolic and systolic blood pressure in children 3 years of age and older
6 and 12 months post-randomization
laboratory measures of cardiometabolic risk
Time Frame: At 12 months post-randomization
laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status
At 12 months post-randomization
Feasibility of intervention
Time Frame: at 12 months post randomization
  1. feasibility of study design (i.e., recruitment, outcome assessment)
  2. feasibility of intervention (i.e., intervention fidelity)
  3. acceptability of study design (i.e., randomization),
  4. acceptability of intervention (i.e., attendance, parent satisfaction).
at 12 months post randomization
Cost effectiveness analysis
Time Frame: at 12 months post-randomization
to determine the incremental costs of the intervention
at 12 months post-randomization

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heart and Stroke Foundation of Ontario
The Physicians' Services Incorporated Foundation
Ontario Child Health Support Unit

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine S Birken, MD, MSc, The Hospital for Sick Children

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000054998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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