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

The Hospital for Sick Children

Status: Completed

Conditions: Child Obesity

Treatments: Behavioral: Parenting education program

Study type: Interventional

Funder types: Other

Identifiers

NCT03219697

1000054998

Details and patient eligibility

About

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.

Full 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

Enrollment: 99 patients

Sex: All

Ages: 18 to 48 months old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 2 patient groups

Parenting education program

Experimental group

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.

Treatment:

Behavioral: Parenting education program

Control

No Intervention group

Description:

Receive regular health care