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

Primary Purpose

Child Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SuperFIT
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Obesity

Eligibility Criteria

2 Years - 4 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SuperFIT

    Control

    Arm Description

    This is the intervention group. They will receive the intervention SuperFIT.

    This is the control group. Participants will receive 'care as usual' in this arm.

    Outcomes

    Primary Outcome Measures

    Change in BMI
    Change in physical activity by an Actigraph accelerometer
    Change in Diet, Food and Nutrition by a 24HR recall

    Secondary Outcome Measures

    Full Information

    First Posted
    January 9, 2017
    Last Updated
    August 22, 2019
    Sponsor
    Maastricht University Medical Center
    Collaborators
    Fonds NutsOhra, ZonMw: The Netherlands Organisation for Health Research and Development
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03021980
    Brief Title
    Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial
    Acronym
    SuperFIT
    Official Title
    Development and Evaluation of SuperFIT: Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    July 2019 (Actual)
    Study Completion Date
    July 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maastricht University Medical Center
    Collaborators
    Fonds NutsOhra, ZonMw: The Netherlands Organisation for Health Research and Development

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Child Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    212 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SuperFIT
    Arm Type
    Experimental
    Arm Description
    This is the intervention group. They will receive the intervention SuperFIT.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    This is the control group. Participants will receive 'care as usual' in this arm.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SuperFIT
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in BMI
    Time Frame
    from baseline to one year and 1.5 years after baseline
    Title
    Change in physical activity by an Actigraph accelerometer
    Time Frame
    from baseline to one year and 1.5 years after baseline
    Title
    Change in Diet, Food and Nutrition by a 24HR recall
    Time Frame
    from baseline to one year and 1.5 years after baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sanne Gerards, Dr.
    Organizational Affiliation
    Department of Health Promotion, Maastricht University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    34863245
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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