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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05802160
Other study ID # H18-01434(2)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date April 2, 2025

Study information

Verified date May 2024
Source University of British Columbia
Contact Louise Masse, PhD
Phone 604 875 2000
Email lmasse@bcchr.ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 118
Est. completion date April 2, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Months to 5 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Good Start Matters - Parenting intervention
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.

Locations

Country Name City State
Canada University of British Columbia / BC Children's Hospital Research Institute Vancouver British Columbia

Sponsors (4)

Lead Sponsor Collaborator
University of British Columbia BC Children's Hospital Research Institute, Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Parenting practices (parent outcome) 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)
Secondary Change in Co-Parenting practices (parent outcome) 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. Two time points (baseline and 10 weeks post intervention)
Secondary Change in Eating and dietary behaviors (child outcome) 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. Two time points (baseline and 10 weeks post intervention)
Secondary Change in Physical activity (child outcome) 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. Two time points (baseline and 10 weeks post intervention)
Secondary Change in Screen time (child outcome) Questions created for this study to examine children's time in front of screens. Greater scores indicate greater screen time. Two time points (baseline and 10 weeks post intervention)
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