Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial
SuperFIT
Development and Evaluation of SuperFIT: Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial.
1 other identifier
interventional
212
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 9, 2017
CompletedFirst Posted
Study publicly available on registry
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedAugust 26, 2019
March 1, 2019
2.5 years
January 9, 2017
August 22, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Change in BMI
from baseline to one year and 1.5 years after baseline
Change in physical activity by an Actigraph accelerometer
from baseline to one year and 1.5 years after baseline
Change in Diet, Food and Nutrition by a 24HR recall
from baseline to one year and 1.5 years after baseline
Study Arms (2)
SuperFIT
EXPERIMENTALThis is the intervention group. They will receive the intervention SuperFIT.
Control
NO INTERVENTIONThis is the control group. Participants will receive 'care as usual' in this arm.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
van de Kolk I, Gerards S, Verhees A, Kremers S, Gubbels J. Changing the preschool setting to promote healthy energy balance-related behaviours of preschoolers: a qualitative and quantitative process evaluation of the SuperFIT approach. Implement Sci. 2021 Dec 4;16(1):101. doi: 10.1186/s13012-021-01161-9.
PMID: 34863245DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanne Gerards, Dr.
Department of Health Promotion, Maastricht University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2017
First Posted
January 16, 2017
Study Start
January 1, 2017
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
August 26, 2019
Record last verified: 2019-03