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Completed

NCT Number: NCT03219697

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

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.

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Key information

Conditions

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

Age range

18 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Michael's Hospital, Toronto, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. zBMI

    Time frame: at 6 months and 12 months post-randomization

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

Secondary outcomes

  1. Mental health

    Time frame: at 6 months and 12 months post-randomization

    Assess mental health by Strengths and Difficulties Questionnaire

  2. Eating behaviour and dietary intake

    Time frame: at 6 months and 12 months post-randomization

    Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)

  3. ZBMI

    Time frame: at 6 months and 12 months post-randomization

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

  4. Physical Activity, Sedentary Time, Sleep Duration

    Time frame: at 6 months and 12 months post-randomization

    Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey),

  5. Physical Activity

    Time frame: At 12 months post-randomization

    Direct measures of physical activity using accelerometry

  6. Psychosocial Health

    Time frame: at 6 months and 12 months post-randomization

    family psychosocial health (using the Parental Stress Index)

  7. Maternal Mental Health

    Time frame: at 6 months and 12 months post-randomization

    maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire)

  8. Parenting

    Time frame: at 6 months and 12 months post-randomization

    Parenting (using the Parenting Scale)

  9. sociodemographic, maternal and child characteristics

    Time frame: at 6 months and 12 months post-randomization

    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).

  10. Waist circumference

    Time frame: 6 and 12 months post randomization

    measured waist circumference using a tape measure

  11. blood pressure

    Time frame: 6 and 12 months post-randomization

    measurement of diastolic and systolic blood pressure in children 3 years of age and older

  12. laboratory measures of cardiometabolic risk

    Time frame: At 12 months post-randomization

    laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status

  13. Feasibility of intervention

    Time frame: at 12 months post randomization

    • 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).

  14. Cost effectiveness analysis

    Time frame: at 12 months post-randomization

    to determine the incremental costs of the intervention

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Heart and Stroke Foundation of Ontario
  • Ontario Child Health Support Unit
  • The Physicians' Services Incorporated Foundation

Registry information

Acronym: PARENT

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2017
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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