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Child ObesityPARENTNCT03219697

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

A study testing Parenting education program in people with Child Obesity, run by The Hospital for Sick Children at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 48 monthsHealthy volunteers can take part
Conditions the study is for
Child Obesity
What is being tested?
Parenting education program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
2 sitesCanada
Study dates
1 May 2018to 15 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 48 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Canada2 sites

  • St Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 0A4

Other trials in Canada

About this study

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.

Read the detailed 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

Conditions
Child Obesity
Being tested
Parenting education program
Keywords
Childhood obesity prevention;
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parenting education programBehavioural

    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.

Study groups in NCT03219697
Study groupRoleWhat they receive
Parenting education programExperimental8 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.
Receives: Behavioral: Parenting education program
ControlNo interventionReceive regular health care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. zBMI

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

    Measured: at 6 months and 12 months post-randomization

Secondary outcomes (14)

  1. Mental health

    Assess mental health by Strengths and Difficulties Questionnaire

    Measured: at 6 months and 12 months post-randomization

  2. Eating behaviour and dietary intake

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

    Measured: at 6 months and 12 months post-randomization

  3. ZBMI

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

    Measured: at 6 months and 12 months post-randomization

  4. Physical Activity, Sedentary Time, Sleep Duration

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

    Measured: at 6 months and 12 months post-randomization

  5. Physical Activity

    Direct measures of physical activity using accelerometry

    Measured: At 12 months post-randomization

  6. Psychosocial Health

    family psychosocial health (using the Parental Stress Index)

    Measured: at 6 months and 12 months post-randomization

  7. Maternal Mental Health

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

    Measured: at 6 months and 12 months post-randomization

  8. Parenting

    Parenting (using the Parenting Scale)

    Measured: at 6 months and 12 months post-randomization

  9. sociodemographic, maternal and child characteristics

    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).

    Measured: at 6 months and 12 months post-randomization

  10. Waist circumference

    measured waist circumference using a tape measure

    Measured: 6 and 12 months post randomization

  11. blood pressure

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

    Measured: 6 and 12 months post-randomization

  12. laboratory measures of cardiometabolic risk

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

    Measured: At 12 months post-randomization

  13. Feasibility of intervention

    1. feasibility of study design (i.e., recruitment, outcome assessment)
    2. feasibility of intervention (i.e., intervention fidelity)
    3. acceptability of study design (i.e., randomization),
    4. acceptability of intervention (i.e., attendance, parent satisfaction).

    Measured: at 12 months post randomization

  14. Cost effectiveness analysis

    to determine the incremental costs of the intervention

    Measured: at 12 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2017
  2. Study start1 May 2018
  3. Primary completion15 Sep 2023
  4. Study completion15 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Control Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03219697
Sponsor's protocol ID
1000054998
Acronym
PARENT
Status last verified
Dec 2024
First submitted
27 Jun 2017
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36600302

Questions about this trial

What is this clinical trial studying?

A study testing Parenting education program in people with Child Obesity, run by The Hospital for Sick Children at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

zBMI (time frame: at 6 months and 12 months post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03219697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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