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

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: Recruiting
• Conditions: Child Obesity
• Intervention / Treatment: Behavioral: Parenting education program

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: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine S Birken, MD, MSc; Phone Number: 301544 416-813-7654; Email: catherine.birken@sickkids.ca
• Study Contact Backup: Name: Mateenah Jaleel, BSc; Phone Number: 647 674 5016; Email: mateenah.jaleel@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 0A4
      • Recruiting
      • The Hospital for Sick Children
      • Contact: Mateenah Jaleel, BSc; Phone Number: 647 674 5016; Email: mateenah.jaleel@sickkids.ca
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St Michael's Hospital
      • Contact: Dalah Mason, MPH; Phone Number: 416-813-7654; Email: dalah.mason@sickkids.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
zBMI	Measure the difference in age and sex-standardized BMI z-score (zBMI)	at 6 months and 12 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health	Assess mental health by Strengths and Difficulties Questionnaire	at 6 months and 12 months post-randomization
Eating behaviour and dietary intake	Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)	at 6 months and 12 months post-randomization
ZBMI	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	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	Direct measures of physical activity using accelerometry	At 12 months post-randomization
Psychosocial Health	family psychosocial health (using the Parental Stress Index)	at 6 months and 12 months post-randomization
Maternal Mental Health	maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire)	at 6 months and 12 months post-randomization
Parenting	Parenting (using the Parenting Scale)	at 6 months and 12 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 - captured by the Nutrition and Health Questionnaire (NHQ).	at 6 months and 12 months post-randomization
Waist circumference	measured waist circumference using a tape measure	6 and 12 months post randomization
blood pressure	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	laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status	At 12 months post-randomization
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).	at 12 months post randomization
Cost effectiveness analysis	to determine the incremental costs of the intervention	at 12 months post-randomization

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Heart and Stroke Foundation of Ontario; The Physicians' Services Incorporated Foundation; Ontario Child Health Support Unit
• Investigators: Principal Investigator: Catherine S Birken, MD, MSc, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ANTICIPATED): April 15, 2023
• Study Completion (ANTICIPATED): April 15, 2023

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (ACTUAL): July 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Childhood obesity prevention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID 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