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Trial record 7 of 107 for:    Recruiting, Not yet recruiting, Available Studies | "Parenting"

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

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ClinicalTrials.gov Identifier: NCT03219697
Recruitment Status : Not yet recruiting
First Posted : July 17, 2017
Last Update Posted : February 12, 2018
Information provided by (Responsible Party):
Catherine Birken, The Hospital for Sick Children

Brief Summary:

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-3 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 10-weeks of group parenting education sessions with 2-4 public health nurse home visits Group B: Receive regular health care

In addition to the measures collected as part of TARGet Kids!, research assistants will collect the following information about you and your child before the start of the trial, and after 6-months:

Parenting Questionnaires from the parent Depression, Anxiety, Stress Scale (DASS-21) from the parent A blood sample from your child

We will measure the differences in weight, height, social, emotional and behavioural health, nutrition, physical activity, sleep, risk for heart disease and diabetes, and health care use.

Condition or disease Intervention/treatment
Child Obesity Behavioral: Parenting education program

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing and Addressing At-obesity-Risk Early Years iNtervention With Home Visits in Toronto (PARENT): A Pragmatic RCT
Anticipated Study Start Date : February 12, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Parenting education program
Receive 10 weeks of group parenting education sessions with 2-4 public health nurse home visits
Behavioral: Parenting education program
If you are in the parenting education program group, you will be enrolled in our 10-week parenting education program, followed by three monthly 1-hr sessions. You and/or your partner will attend weekly parenting sessions which will take place at the office of your child's primary care provider for 10 weeks, followed by 3 booster sessions. Our Toronto Public Health Nurse, will arrange 2-4 home visits with you and your family 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 in your home, and making connections in your neighbourhood that you find helpful such as recreational or nutrition programs or other supports for your family.
No Intervention: Control
Receive regular health care

Primary Outcome Measures :
  1. zBMI [ Time Frame: 6 months post-intervention ]
    Measure the difference in age and sex-standardized BMI z-score (zBMI)

Secondary Outcome Measures :
  1. Mental health [ Time Frame: 6 months post-intervention ]
    Assess mental health by Strengths and Difficulties Questionnaire

  2. Eating behaviour and dietary intake [ Time Frame: 6 months post-intervention ]
    Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 and paternal obesity,
  • gestational smoking at birth

Exclusion Criteria:

  • Young children with Prader-Willi syndrome or severe developmental delays
  • families not fluent in English
  • families who reside beyond the Toronto Public Health catchment areas for home visiting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219697

Contact: Catherine S Birken, MD 416-813-7654 ext 301544 catherine.birken@sickkids.ca
Contact: Christine Kowal 416-813-7654 ext 309441 Christine.Kowal@sickkids.ca

Sponsors and Collaborators
The Hospital for Sick Children

Responsible Party: Catherine Birken, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03219697     History of Changes
Other Study ID Numbers: 1000054998
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catherine Birken, The Hospital for Sick Children:
Childhood obesity prevention;

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms