Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial

Child Obesity Clinical Trial

— SuperFIT  

Official title:

Development and Evaluation of SuperFIT: Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021980
• Other study ID #: NL58061.068.16
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2019

Study information

• Verified date: March 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of SuperFIT, an integrative lifestyle intervention for preschool children. It will consist of both an preschool component and a family component and is aimed at increasing healthy nutrition and physical activity. Half of the participating preschools will implement SuperFIT, while the other half of the preschools will continue as usual.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

Inclusion Criteria:

• children attending the participating preschools

• at least one parent has to be able to understand the Dutch language

• Both caregivers (if applicable) of the child give informed consent

Exclusion Criteria:

• There are no exclusion criteria for this study

Related Conditions & MeSH terms

• Child Obesity
• Pediatric Obesity

Intervention

Behavioral:
• SuperFIT
Behavioural intervention with two components. One component will consist of social and physical environmental changes at the preschools and the other component consists of a family educational program.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Fonds NutsOhra, ZonMw: The Netherlands Organisation for Health Research and Development

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI		from baseline to one year and 1.5 years after baseline
Primary	Change in physical activity by an Actigraph accelerometer		from baseline to one year and 1.5 years after baseline
Primary	Change in Diet, Food and Nutrition by a 24HR recall		from baseline to one year and 1.5 years after baseline