Child ObesitySuperFITNCT03021980
Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial
A study testing SuperFIT in people with Child Obesity, run by Maastricht University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Obesity
- What is being tested?
- SuperFIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria for this study
About this study
Official title: Development and Evaluation of SuperFIT: 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.
- Conditions
- Child Obesity
- Being tested
- SuperFIT
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperFITBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SuperFIT | Experimental | This is the intervention group. They will receive the intervention SuperFIT. Receives: Behavioral: SuperFIT |
| Control | No intervention | This is the control group. Participants will receive 'care as usual' in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
Measured: from baseline to one year and 1.5 years after baseline
Change in physical activity by an Actigraph accelerometer
Measured: from baseline to one year and 1.5 years after baseline
Change in Diet, Food and Nutrition by a 24HR recall
Measured: from baseline to one year and 1.5 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds NutsOhra, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Sanne Gerards, Dr., Principal investigator, Department of Health Promotion, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021980
- Sponsor's protocol ID
- NL58061.068.16
- Acronym
- SuperFIT
- Status last verified
- Mar 2019
- First submitted
- 9 Jan 2017
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34863245
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of SuperFIT: Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial.
- ClinicalTrials.gov ID
- NCT03021980
- Acronym / sponsor ID
- SuperFIT / NL58061.068.16
- Conditions
- Child Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Fonds NutsOhra, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jan 2017
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SuperFIT | Experimental | Behavioral: SuperFITThis is the intervention group. They will receive the intervention SuperFIT. |
| Control | No intervention | –This is the control group. Participants will receive 'care as usual' in this arm. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuperFITBehavioural 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. | Behavioural | SuperFIT |
Primary outcome
Change in BMI
Time frame: from baseline to one year and 1.5 years after baseline
Change in physical activity by an Actigraph accelerometer
Time frame: from baseline to one year and 1.5 years after baseline
Change in Diet, Food and Nutrition by a 24HR recall
Time frame: from baseline to one year and 1.5 years after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Derived from this study: PubMed 34863245van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanne Gerards, Dr. principal investigator
Department of Health Promotion, Maastricht University
Questions about this trial
What is this clinical trial studying?
A study testing SuperFIT in people with Child Obesity, run by Maastricht University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI (time frame: from baseline to one year and 1.5 years after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.