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OpenTrials
Completed

NCT Number: NCT03021980

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

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.

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Key information

Conditions

Child Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SuperFIT

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.

Primary outcomes

  1. Change in BMI

    Time frame: from baseline to one year and 1.5 years after baseline

  2. Change in physical activity by an Actigraph accelerometer

    Time frame: from baseline to one year and 1.5 years after baseline

  3. Change in Diet, Food and Nutrition by a 24HR recall

    Time frame: from baseline to one year and 1.5 years after baseline

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Fonds NutsOhra
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: SuperFIT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2017
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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