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Preventing and Addressing At-obesity-Risk Early Years iNtervention With Home Visits in Toronto (PARENT): A Pragmatic RCT (PARENT)

Primary Purpose

Child Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Parenting education program
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Obesity focused on measuring Childhood obesity prevention;

Eligibility Criteria

18 Months - 48 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St Michael's HospitalRecruiting
  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parenting education program

Control

Arm Description

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.

Receive regular health care

Outcomes

Primary Outcome Measures

zBMI
Measure the difference in age and sex-standardized BMI z-score (zBMI)

Secondary Outcome Measures

Mental health
Assess mental health by Strengths and Difficulties Questionnaire
Eating behaviour and dietary intake
Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)
ZBMI
Measure the difference in age and sex-standardized BMI z-score (zBMI)
Physical Activity, Sedentary Time, Sleep Duration
Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey),
Physical Activity
Direct measures of physical activity using accelerometry
Psychosocial Health
family psychosocial health (using the Parental Stress Index)
Maternal Mental Health
maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire)
Parenting
Parenting (using the Parenting Scale)
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 - captured by the Nutrition and Health Questionnaire (NHQ).
Waist circumference
measured waist circumference using a tape measure
blood pressure
measurement of diastolic and systolic blood pressure in children 3 years of age and older
laboratory measures of cardiometabolic risk
laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status
Feasibility of intervention
feasibility of study design (i.e., recruitment, outcome assessment) feasibility of intervention (i.e., intervention fidelity) acceptability of study design (i.e., randomization), acceptability of intervention (i.e., attendance, parent satisfaction).
Cost effectiveness analysis
to determine the incremental costs of the intervention

Full Information

First Posted
June 27, 2017
Last Updated
July 6, 2022
Sponsor
The Hospital for Sick Children
Collaborators
Heart and Stroke Foundation of Ontario, The Physicians' Services Incorporated Foundation, Ontario Child Health Support Unit
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1. Study Identification

Unique Protocol Identification Number
NCT03219697
Brief Title
Preventing and Addressing At-obesity-Risk Early Years iNtervention With Home Visits in Toronto (PARENT): A Pragmatic RCT
Acronym
PARENT
Official Title
Preventing and Addressing At-obesity-Risk Early Years iNtervention With Home Visits in Toronto (PARENT): A Pragmatic RCT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Heart and Stroke Foundation of Ontario, The Physicians' Services Incorporated Foundation, Ontario Child Health Support Unit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Obesity
Keywords
Childhood obesity prevention;

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parenting education program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Receive regular health care
Intervention Type
Behavioral
Intervention Name(s)
Parenting education program
Intervention Description
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.
Primary Outcome Measure Information:
Title
zBMI
Description
Measure the difference in age and sex-standardized BMI z-score (zBMI)
Time Frame
at 6 months and 12 months post-randomization
Secondary Outcome Measure Information:
Title
Mental health
Description
Assess mental health by Strengths and Difficulties Questionnaire
Time Frame
at 6 months and 12 months post-randomization
Title
Eating behaviour and dietary intake
Description
Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)
Time Frame
at 6 months and 12 months post-randomization
Title
ZBMI
Description
Measure the difference in age and sex-standardized BMI z-score (zBMI)
Time Frame
at 6 months and 12 months post-randomization
Title
Physical Activity, Sedentary Time, Sleep Duration
Description
Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey),
Time Frame
at 6 months and 12 months post-randomization
Title
Physical Activity
Description
Direct measures of physical activity using accelerometry
Time Frame
At 12 months post-randomization
Title
Psychosocial Health
Description
family psychosocial health (using the Parental Stress Index)
Time Frame
at 6 months and 12 months post-randomization
Title
Maternal Mental Health
Description
maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire)
Time Frame
at 6 months and 12 months post-randomization
Title
Parenting
Description
Parenting (using the Parenting Scale)
Time Frame
at 6 months and 12 months post-randomization
Title
sociodemographic, maternal and child characteristics
Description
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).
Time Frame
at 6 months and 12 months post-randomization
Title
Waist circumference
Description
measured waist circumference using a tape measure
Time Frame
6 and 12 months post randomization
Title
blood pressure
Description
measurement of diastolic and systolic blood pressure in children 3 years of age and older
Time Frame
6 and 12 months post-randomization
Title
laboratory measures of cardiometabolic risk
Description
laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status
Time Frame
At 12 months post-randomization
Title
Feasibility of intervention
Description
feasibility of study design (i.e., recruitment, outcome assessment) feasibility of intervention (i.e., intervention fidelity) acceptability of study design (i.e., randomization), acceptability of intervention (i.e., attendance, parent satisfaction).
Time Frame
at 12 months post randomization
Title
Cost effectiveness analysis
Description
to determine the incremental costs of the intervention
Time Frame
at 12 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine S Birken, MD, MSc
Phone
416-813-7654
Ext
301544
Email
catherine.birken@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mateenah Jaleel, BSc
Phone
647 674 5016
Email
mateenah.jaleel@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine S Birken, MD, MSc
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalah Mason, MPH
Phone
416-813-7654
Email
dalah.mason@sickkids.ca
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 0A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mateenah Jaleel, BSc
Phone
647 674 5016
Email
mateenah.jaleel@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Catherine S Birken, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventing and Addressing At-obesity-Risk Early Years iNtervention With Home Visits in Toronto (PARENT): A Pragmatic RCT

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