ObesityNCT00987532
A Participatory Parental Intervention Promoting Physical Activity in Preschools
A study testing parent-focused intervention and twice weekly gym lessons in people with Obesity and Physical Activity, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
The aim of this study is to test whether a parent-focused participatory intervention in addition to gym lessons can enhance preschoolers physical activity compared to gym lessons alone. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- parent-focused intervention and twice weekly gym lessons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,047 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Mar 2011
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 3-6 years
Who cannot join
- severe atopic dermatitis,
- serious acute infectious diseases,
- physical malformations, and
- severe physical disabilities.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Mannheim Institute of Public Health, Medical Faculty Mannheim, Heidelberg University
Mannheim, Baden-Wurttemberg, 68167
About this study
The aim of this study is to test whether a parent-focused participatory intervention in addition to gym lessons can enhance preschoolers physical activity compared to gym lessons alone.
Read the detailed description
Over the last 20 years, physical activity (PA) in children has rapidly decreased in both developed and developing nations. More effective interventions to prevent inactivity in childhood thus are urgently needed. The preschool years, including the adiposity rebound period, might represent a good window of opportunity. Study literature suggests that targeting parents is crucial for lasting changes in young childrens' behavior. However, it is not known which methods are effective for involving parents in physical activity promotion. Consistent with experience from community-based participatory research, encouraging parents to participate the intervention in terms of content and structure might lead to higher intervention effectivity and sustainability. In our study, we therefore "enriched" a child-centered physical activity intervention in preschools (twice weekly gym lessons over 6 months) with a parent-focused participatory community intervention component.
- Conditions
- Obesity, Physical Activity
- Being tested
- parent-focused intervention, twice weekly gym lessons
- Keywords
- preschool, participatory intervention, cluster-randomization, children, obesity prevention
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent-focused interventionBehavioural
Also called Ene mene fit - Eltern machen mit
The core of the parent-focused intervention is a menu of 15 easy to realize project ideas to promote the everyday physical activity of children and families. The 15 ideas are presented to the parents and teachers via a webpage, a printed book and a film. During a face-to-face meeting, parents and teachers are guided into discussions of their own preschool environment's and community's physical activity shortcomings and encouraged to generate their own ideas of how to enhance the physical activity of their families and preschools. Over the course of three structured follow-up meetings, parents and teachers are instructed to choose maximally 3 to 4 ideas from either the menu or the network's own ideas, and then are empowered to realize and implement them together.
twice weekly gym lessonsBehavioural
Also called child-centered physical activity intervention
twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months
| Study group | Role | What they receive |
|---|---|---|
| parent intervention plus gym lessons | Experimental | Parent-focused participatory preschool intervention in addition to twice weekly gym lessons over 6 months. The participatory intervention includes parents, teachers and children. Receives: Behavioral: parent-focused intervention; Behavioral: twice weekly gym lessons |
| gym lessons only | Active comparator | Twice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months Receives: Behavioral: twice weekly gym lessons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in mean accelerometry counts over 6 days
Measured: baseline, end of intervention, six months after end of intervention
Secondary outcomes (1)
Body Mass Index
Measured: baseline, end of intervention, six months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,047 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Baden-Württemberg Stiftung gGmbH
- Responsible party
- Principal investigator, Joachim E. Fischer, MD MSc, Universitätsmedizin Mannheim
- Investigators
- Joachim E. Fischer, MD, M.Sc., Principal investigator, Mannheim Institute of Public Health, Medical Faculty Mannheim, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987532
- Sponsor's protocol ID
- MIPH_KITA2008
- Status last verified
- May 2023
- First submitted
- 30 Sep 2009
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
De Bock F, Genser B, Raat H, Fischer JE, Renz-Polster H. A participatory physical activity intervention in preschools: a cluster randomized controlled trial. Am J Prev Med. 2013 Jul;45(1):64-74. doi: 10.1016/j.amepre.2013.01.032.
PubMed 23790990De Bock F, Fischer JE, Hoffmann K, Renz-Polster H. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial. BMC Public Health. 2010 Jan 31;10:49. doi: 10.1186/1471-2458-10-49.
PubMed 20113522
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Participatory Parental Intervention Promoting Physical Activity in Preschools
- ClinicalTrials.gov ID
- NCT00987532
- Acronym / sponsor ID
- MIPH_KITA2008
- Conditions
- Obesity, Physical Activity
- Keywords
- preschool, participatory intervention, cluster-randomization, children, obesity prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,047 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- Baden-Württemberg Stiftung gGmbH
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 1 Oct 2009 (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.
The aim of this study is to test whether a parent-focused participatory intervention in addition to gym lessons can enhance preschoolers physical activity compared to gym lessons alone.
Detailed description
Over the last 20 years, physical activity (PA) in children has rapidly decreased in both developed and developing nations. More effective interventions to prevent inactivity in childhood thus are urgently needed. The preschool years, including the adiposity rebound period, might represent a good window of opportunity. Study literature suggests that targeting parents is crucial for lasting changes in young childrens' behavior. However, it is not known which methods are effective for involving parents in physical activity promotion. Consistent with experience from community-based participatory research, encouraging parents to participate the intervention in terms of content and structure might lead to higher intervention effectivity and sustainability. In our study, we therefore "enriched" a child-centered physical activity intervention in preschools (twice weekly gym lessons over 6 months) with a parent-focused participatory community intervention component.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parent intervention plus gym lessons | Experimental | Behavioral: parent-focused intervention, Behavioral: twice weekly gym lessonsParent-focused participatory preschool intervention in addition to twice weekly gym lessons over 6 months. The participatory intervention includes parents, teachers and children. |
| gym lessons only | Active comparator | Behavioral: twice weekly gym lessonsTwice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- age 3-6 years
Key exclusion criteria (4 listed)
- severe atopic dermatitis,
- serious acute infectious diseases,
- physical malformations, and
- severe physical disabilities.
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 |
|---|---|---|
| parent-focused interventionAlso: Ene mene fit - Eltern machen mitThe core of the parent-focused intervention is a menu of 15 easy to realize project ideas to promote the everyday physical activity of children and families. The 15 ideas are presented to the parents and teachers via a webpage, a printed book and a film. During a face-to-face meeting, parents and teachers are guided into discussions of their own preschool environment's and community's physical activity shortcomings and encouraged to generate their own ideas of how to enhance the physical activity of their families and preschools. Over the course of three structured follow-up meetings, parents and teachers are instructed to choose maximally 3 to 4 ideas from either the menu or the network's own ideas, and then are empowered to realize and implement them together. | Behavioural | parent intervention plus gym lessons |
| twice weekly gym lessonsAlso: child-centered physical activity interventiontwice weekly one-hour gym lessons delivered by a specially trained external physical education teacher over 6 months | Behavioural | gym lessons only, parent intervention plus gym lessons |
Primary outcome
Absolute change in mean accelerometry counts over 6 days
Time frame: baseline, end of intervention, six months after end of intervention
1 secondary outcome
Body Mass Index
Time frame: baseline, end of intervention, six months after end of intervention
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 11 May 2023.
- Derived from this study: PubMed 23790990De Bock F, Genser B, Raat H, Fischer JE, Renz-Polster H. A participatory physical activity intervention in preschools: a cluster randomized controlled trial. Am J Prev Med. 2013 Jul;45(1):64-74. doi: 10.1016/j.amepre.2013.01.032.
- Derived from this study: PubMed 20113522De Bock F, Fischer JE, Hoffmann K, Renz-Polster H. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial. BMC Public Health. 2010 Jan 31;10:49. doi: 10.1186/1471-2458-10-49.
- webpage of the participatory parent-focused interventionLink provided by the sponsor.
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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.
Joachim E. Fischer, MD, M.Sc. principal investigator
Mannheim Institute of Public Health, Medical Faculty Mannheim, Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parent-focused intervention and twice weekly gym lessons in people with Obesity and Physical Activity, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 1 inclusion and 4 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Absolute change in mean accelerometry counts over 6 days (time frame: baseline, end of intervention, six months after end of intervention). 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 NCT00987532, which also lists 2 linked publications.
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 11 May 2023.