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

Child Obesity Clinical Trial

— PARENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03219697
• Other study ID #: 1000054998
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: April 15, 2023

Study information

• Verified date: July 2022
• Source: The Hospital for Sick Children
• Contact: Catherine S Birken, MD, MSc
• Phone: 416-813-7654
• Email: catherine.birken[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 48 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	St Michael's Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Heart and Stroke Foundation of Ontario, Ontario Child Health Support Unit, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	zBMI	Measure the difference in age and sex-standardized BMI z-score (zBMI)	at 6 months and 12 months post-randomization
Secondary	Mental health	Assess mental health by Strengths and Difficulties Questionnaire	at 6 months and 12 months post-randomization
Secondary	Eating behaviour and dietary intake	Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)	at 6 months and 12 months post-randomization
Secondary	ZBMI	Measure the difference in age and sex-standardized BMI z-score (zBMI)	at 6 months and 12 months post-randomization
Secondary	Physical Activity, Sedentary Time, Sleep Duration	Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey),	at 6 months and 12 months post-randomization
Secondary	Physical Activity	Direct measures of physical activity using accelerometry	At 12 months post-randomization
Secondary	Psychosocial Health	family psychosocial health (using the Parental Stress Index)	at 6 months and 12 months post-randomization
Secondary	Maternal Mental Health	maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire)	at 6 months and 12 months post-randomization
Secondary	Parenting	Parenting (using the Parenting Scale)	at 6 months and 12 months post-randomization
Secondary	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).	at 6 months and 12 months post-randomization
Secondary	Waist circumference	measured waist circumference using a tape measure	6 and 12 months post randomization
Secondary	blood pressure	measurement of diastolic and systolic blood pressure in children 3 years of age and older	6 and 12 months post-randomization
Secondary	laboratory measures of cardiometabolic risk	laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status	At 12 months post-randomization
Secondary	Feasibility of intervention	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).	at 12 months post randomization
Secondary	Cost effectiveness analysis	to determine the incremental costs of the intervention	at 12 months post-randomization