- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05802160
The Good Start Matters - Parenting Program
March 26, 2023 updated by: Louise Masse, University of British Columbia
A Good Start Matters for Parents and Children: An mHealth Parenting Intervention to Promote a Healthy Child Development
Early childhood is an important period where the family can support the development and maintenance of healthy eating and active behaviors to prevent or reduce childhood obesity.
With this ultimate goal, we designed the Good Start Matters - Parenting program, which aims to engage families in positive parenting practices that support healthy child behaviors, and aim to evaluate the efficacy of this intervention with a Randomized Controlled Trial (RCT).
The Good Start Matters - Parenting program is a 2-month mobile-Health (mHealth) parenting intervention which promote positive parenting (primary outcome) and support children's healthy nutrition, physical activity, and decrease screen-time (secondary outcomes).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Early childhood is an important learning period where dietary, physical activity and sedentary habits are forming, and developing unhealthy habits will set children up for obesity and other health risks later in life.
Moreover, during early childhood the familial environment plays a key role in shaping children's behaviors through their parenting practices, which altogether illustrate the potential of the early years as a developmental period with opportunities for obesity prevention.
This Randomized Controlled Trial (RCT) evaluates the efficacy of the Good Start Matters - Parenting intervention, a mobile-Health (mHealth) aimed at improving parenting and co-parenting practices and child health behaviors among British Columbian families of preschoolers.
Participating families complete measurement tools at baseline and after 10 weeks.
Families randomized into the intervention condition receive immediate access to the app, and control families receive access to the app after the completion of the second assessment.
We expect that compared to control group families, intervention group families significantly improve their parenting and co-parenting practices and improve child health behaviors after 2 months of app use.
Study Type
Interventional
Enrollment (Anticipated)
118
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Louise Masse, PhD
- Phone Number: 5563 604 875 2000
- Email: lmasse@bcchr.ubc.ca
Study Contact Backup
- Name: Olivia de Jongh, PhD
- Phone Number: 6393 6048752000
- Email: olivia.djgonzalez@bcchr.ca
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- University of British Columbia / BC Children's Hospital Research Institute
-
Contact:
- Olivia de Jongh, PhD
- Phone Number: 6393 6048752000
- Email: olivia.djgonzalez@bcchr.ca
-
Contact:
- Louise Masse, PhD
- Phone Number: 5563 6048752000
- Email: lmasse@bcchr.ubc.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Children must be:
- Attending a childcare center invited to participate in the Good Start Matters study.
- Aged 2.5 to 5 years
Parents must:
- Be the primary caregiver/legal guardian of an eligible child OR share childrearing responsibilities with an already enrolled primary caregiver/legal guardian of an eligible child
- Be fluent in English
- Have a cellphone number and smartphone device where they can receive text messages and download and access the app
Exclusion Criteria:
Parents and children:
- Currently participating in a pediatric weight management program or in a nutritional program are not eligible.
Children:
- With severe dietary restrictions that limit their ability to follow general nutritional guidelines for 2.5-5-year-olds are not eligible.
- With severe physical limitations that limit their ability to follow general movement behavior guidelines for 2.5-5-year-olds are not eligible.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Good Start Matters Parenting intervention
The intervention group will receive immediate access to the app where the Good Start Matters - Parenting intervention will be delivered over a 2-months period.
|
The Good Start Matters - Parenting intervention is a 2-month mobile-Health (mHealth) parenting program that aims to improve parenting practices and child health behaviors among British Columbian families of preschoolers.
This intervention uses a familial approach and blends the best practices and evidence to promote positive parenting regarding 3 main areas: nutrition, physical activity, and screen-time; which altogether aim to support the development of healthy habits among young children.
The mHealth app releases new material on a weekly basis and participants' engagement with the app takes about 30 minutes per week.
|
No Intervention: Control
The control group will not receive access to the intervention until they complete the follow-up measures (after 10 weeks).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Parenting practices (parent outcome)
Time Frame: Two time points (baseline and 10 weeks post intervention)
|
Questions adapted from the "Food and Physical Activity Item Banks" (Masse et al 2020) to specifically assess parenting practices related to food, physical activity and screen time.
The scale ranges from 1-5 in most items, and higher scores indicate greater endorsement of each parenting practice.
|
Two time points (baseline and 10 weeks post intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Co-Parenting practices (parent outcome)
Time Frame: Two time points (baseline and 10 weeks post intervention)
|
Questions adapted from the "Coparenting Relationship Scale" from Feinberg et al (2012) to measure co-parenting agreement specifically regarding the child eating and movement behaviors.
The scale ranges from 1-4 and all items will be coded in the same direction to have greater scores representing greater coparenting agreement.
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Two time points (baseline and 10 weeks post intervention)
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Change in Eating and dietary behaviors (child outcome)
Time Frame: Two time points (baseline and 10 weeks post intervention)
|
Questions from the "Children´s Eating Behaviors Questionnaire" (CEBQ) (Wardle et al, 2001), questions based on "Canada´s Food Guide" recommendations, and questions created for the current study to assess a variety of children´s eating behaviors around food (e.g., fussiness, emotional overeating) and intake of key food markers (e.g., vegetables, fruits, sugary drinks).
Specifically for the CEBQ scale, response options range from 1-5, and all items will be recoded in the same direction to have greater scores representing greater frequency of each child behavior.
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Two time points (baseline and 10 weeks post intervention)
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Change in Physical activity (child outcome)
Time Frame: Two time points (baseline and 10 weeks post intervention)
|
Questions adapted from Burdette et al. (2004) to examine child physical activity through active play and outdoor play.
Greater scores indicate greater active play and outdoor play time.
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Two time points (baseline and 10 weeks post intervention)
|
Change in Screen time (child outcome)
Time Frame: Two time points (baseline and 10 weeks post intervention)
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Questions created for this study to examine children's time in front of screens.
Greater scores indicate greater screen time.
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Two time points (baseline and 10 weeks post intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Louise Masse, PhD, University Of British Columbia & BC Children's Hospital Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2023
Primary Completion (Anticipated)
April 1, 2024
Study Completion (Anticipated)
April 2, 2024
Study Registration Dates
First Submitted
March 15, 2023
First Submitted That Met QC Criteria
March 26, 2023
First Posted (Actual)
April 6, 2023
Study Record Updates
Last Update Posted (Actual)
April 6, 2023
Last Update Submitted That Met QC Criteria
March 26, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H18-01434(2)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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