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

NCT03219697 | Completed

• 1 other identifier: 1000054998
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

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.

Conditions

Child Obesity

Keywords

Childhood obesity prevention;

Outcome Measures

Primary Outcomes (1)

• zBMI

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

  at 6 months and 12 months post-randomization

Secondary Outcomes (14)

• Mental health

  at 6 months and 12 months post-randomization

• Eating behaviour and dietary intake

  at 6 months and 12 months post-randomization

• ZBMI

  at 6 months and 12 months post-randomization

• Physical Activity, Sedentary Time, Sleep Duration

  at 6 months and 12 months post-randomization

• Physical Activity

  At 12 months post-randomization

Study Arms (2)

Parenting education program

EXPERIMENTAL

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

Control

NO INTERVENTION

Receive regular health care

Interventions

Parenting education program BEHAVIORAL

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.

Parenting education program

Eligibility Criteria

• Age: 18 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Heart and Stroke Foundation of Ontario: collaborator
• The Physicians' Services Incorporated Foundation: collaborator
• Ontario Child Health Support Unit: collaborator

Study Sites (2)

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 0A4, Canada

Location

Related Publications (1)

• Rae S, Maguire J, Aglipay M, Barwick M, Danavan K, Haines J, Jenkins J, Klaassen M, Moretti ME, Ong F, Persaud N, Porepa M, Straus S, Tavares E, Willan A, Birken C. Randomized controlled trial evaluating a virtual parenting intervention for young children at risk of obesity: study protocol for Parenting Addressing Early Years Intervention with Coaching Visits in Toronto (PARENT) trial. Trials. 2023 Jan 4;24(1):8. doi: 10.1186/s13063-022-06947-w.

  PMID: 36600302 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine S Birken, MD, MSc

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 17, 2017
• Study Start: May 1, 2018
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)