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

NCT ID: NCT03021980

Last Updated: 2019-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Child Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SuperFIT

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

Group Type EXPERIMENTAL

SuperFIT

Intervention Type BEHAVIORAL

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fonds NutsOhra

OTHER

Sponsor Role collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanne Gerards, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Health Promotion, Maastricht University

References

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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.

Reference Type DERIVED
PMID: 34863245 (View on PubMed)

Other Identifiers

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NL58061.068.16

Identifier Type: -

Identifier Source: org_study_id

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