Preventing and Addressing At-obesity-Risk Early Years INtervention with Home Visits in Toronto (PARENT): a Pragmatic RCT
NCT ID: NCT03219697
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2018-05-01
2023-09-15
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
Control
Receive regular health care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Months
48 Months
ALL
Yes
Sponsors
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Heart and Stroke Foundation of Ontario
OTHER
The Physicians' Services Incorporated Foundation
OTHER
Ontario Child Health Support Unit
UNKNOWN
The Hospital for Sick Children
OTHER
Responsible Party
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Catherine Birken
Principal Investigator
Principal Investigators
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Catherine S Birken, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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St Michael's Hospital
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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1000054998
Identifier Type: -
Identifier Source: org_study_id