ObesityNCT01070251
Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial
A study testing Participatory parent-focused intervention and State-sponsored PA program in people with Obesity, run by Heidelberg University at 2 sites in Germany.
Trial summary
This study investigates whether a preschool-based physical activity intervention involving parents as active agents of behavioral change affects objectively measured physical activity in preschool children. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Obesity
- What is being tested?
- Participatory parent-focused intervention and State-sponsored PA program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 826 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2008to Apr 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
- No healthy volunteers
- Child
Who may be able to join
- Healthy children
- Participation in the standard physical activity lesson twice weekly
Who cannot join
- Age under 3 years or above 6 years
- Serious atopic dermatitis
- Genetic conditions
- Metabolic diseases
- Acute infectious diseases
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Mannheim Institute of Public Health, University of Heidelberg
Mannheim, Baden-Wurttemberg, 68167
Mannheim Institute of Public Health
Mannheim, Baden-Wurttemberg, 68167
About this study
This study investigates whether a preschool-based physical activity intervention involving parents as active agents of behavioral change affects objectively measured physical activity in preschool children.
Read the detailed description
In the last 25 years, obesity in children has increased dramatically in Germany (Lampert et al. 2007, Stolzenberg et al., 2007) and other western societies. Lack of physical activity (PA) is one important factor contributing to obesity development. However, healthy behaviors are established early in life (adiposity rebound: Reilly 2008), which underlines the importance of early interventions. Preschools therefore might be an ideal setting for interventions to promote physical activity. While previous preschool interventions were directly aimed at the children's physical activity behaviors (e.g. promoting activity by sports lessons), parents as influential caregivers were mainly involved in educational ways and by information (e.g. newsletters, physical activity homework).
The current intervention takes a participatory approach to involve parents as active agents of behavioral change. The study aim is to evaluate the effects of the participatory preference-based parental intervention on preschoolers' objectively measured physical activity behaviour and Body Mass Index (BMI). The intervention can easily be added as a parent module to existing children-focused physical activity programmes.
In several workshops, parents are presented a set of possible project ideas for improving everyday physical activity in the preschools. After forming teams, they either select project ideas from the preexisting menu or develop ideas de novo and then implement them into the local preschool environment.
The intervention is implemented in the frame of an existing state-sponsored physical activity (PA) program offering twice weekly sports lessons by external gym trainers to preschoolers over a period of 6 months. Preschools in the control arm get the state-sponsored PA program only. Preschools in the intervention arm get the participatory parent-focused PA intervention in addition to the existing state-sponsored PA program.
- Conditions
- Obesity
- Being tested
- Participatory parent-focused intervention, State-sponsored PA program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory parent-focused interventionBehavioural
Also called "Ene mene fit - Eltern machen mit!"
Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program
State-sponsored PA programBehavioural
Also called Standard physical activity lessons
Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
| Study group | Role | What they receive |
|---|---|---|
| Existing state-sponsored PA program | Active comparator | standard children-focused gym lessons approach Receives: Behavioral: State-sponsored PA program |
| Participatory intervention plus state-sponsored PA program | Active comparator | Participatory parent-focused intervention over nine months in addition to state-sponsored PA program Receives: Behavioral: Participatory parent-focused intervention; Behavioral: State-sponsored PA program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity as measured by accelerometry and heart rate
before intervention (0 months), 6 and 12 months later
Measured: 0,6 and 12 months
Secondary outcomes (1)
Change in Body Mass Index, percent fat mass (based on skin folds), waist-to-height ratio and waist circumference Change in blood pressure, sympathetic/parasympathetic tone. Sleep quantity by accelerometry.
before intervention (0 months), 6 and 12 months later
Measured: 0, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionApr 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
- 826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim E. Fischer, Heidelberg University
- Investigators
- Joachim E Fischer, Prof MD MSc, Study director, Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070251
- Sponsor's protocol ID
- CRTLasti_PA_kiga
- Status last verified
- Jul 2012
- First submitted
- 16 Feb 2010
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Reilly JJ, Kelly L, Montgomery C, Williamson A, Fisher A, McColl JH, Lo Conte R, Paton JY, Grant S. Physical activity to prevent obesity in young children: cluster randomised controlled trial. BMJ. 2006 Nov 18;333(7577):1041. doi: 10.1136/bmj.38979.623773.55. Epub 2006 Oct 6.
PubMed 17028105Taylor RW, Mcauley KA, Williams SM, Barbezat W, Nielsen G, Mann JI. Reducing weight gain in children through enhancing physical activity and nutrition: the APPLE project. Int J Pediatr Obes. 2006;1(3):146-52. doi: 10.1080/17477160600881247.
PubMed 17899632
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT01070251
- Acronym / sponsor ID
- CRTLasti_PA_kiga
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 826 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Feb 2010 (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 investigates whether a preschool-based physical activity intervention involving parents as active agents of behavioral change affects objectively measured physical activity in preschool children.
Detailed description
In the last 25 years, obesity in children has increased dramatically in Germany (Lampert et al. 2007, Stolzenberg et al., 2007) and other western societies. Lack of physical activity (PA) is one important factor contributing to obesity development. However, healthy behaviors are established early in life (adiposity rebound: Reilly 2008), which underlines the importance of early interventions. Preschools therefore might be an ideal setting for interventions to promote physical activity. While previous preschool interventions were directly aimed at the children's physical activity behaviors (e.g. promoting activity by sports lessons), parents as influential caregivers were mainly involved in educational ways and by information (e.g. newsletters, physical activity homework).
The current intervention takes a participatory approach to involve parents as active agents of behavioral change. The study aim is to evaluate the effects of the participatory preference-based parental intervention on preschoolers' objectively measured physical activity behaviour and Body Mass Index (BMI). The intervention can easily be added as a parent module to existing children-focused physical activity programmes.
In several workshops, parents are presented a set of possible project ideas for improving everyday physical activity in the preschools. After forming teams, they either select project ideas from the preexisting menu or develop ideas de novo and then implement them into the local preschool environment.
The intervention is implemented in the frame of an existing state-sponsored physical activity (PA) program offering twice weekly sports lessons by external gym trainers to preschoolers over a period of 6 months. Preschools in the control arm get the state-sponsored PA program only. Preschools in the intervention arm get the participatory parent-focused PA intervention in addition to the existing state-sponsored PA program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Existing state-sponsored PA program | Active comparator | Behavioral: State-sponsored PA programstandard children-focused gym lessons approach |
| Participatory intervention plus state-sponsored PA program | Active comparator | Behavioral: Participatory parent-focused intervention, Behavioral: State-sponsored PA programParticipatory parent-focused intervention over nine months in addition to state-sponsored PA program |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children
- Participation in the standard physical activity lesson twice weekly
Key exclusion criteria (5 listed)
- Age under 3 years or above 6 years
- Serious atopic dermatitis
- Genetic conditions
- Metabolic diseases
- Acute infectious diseases
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 |
|---|---|---|
| Participatory parent-focused interventionAlso: "Ene mene fit - Eltern machen mit!"Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program | Behavioural | Participatory intervention plus state-sponsored PA program |
| State-sponsored PA programAlso: Standard physical activity lessonsPreschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer | Behavioural | Existing state-sponsored PA program, Participatory intervention plus state-sponsored PA program |
Primary outcome
Change in physical activity as measured by accelerometry and heart rate
Time frame: 0,6 and 12 months
before intervention (0 months), 6 and 12 months later
1 secondary outcome
Change in Body Mass Index, percent fat mass (based on skin folds), waist-to-height ratio and waist circumference Change in blood pressure, sympathetic/parasympathetic tone. Sleep quantity by accelerometry.
Time frame: 0, 6 and 12 months
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 1 Aug 2012.
- Background: PubMed 17028105Reilly JJ, Kelly L, Montgomery C, Williamson A, Fisher A, McColl JH, Lo Conte R, Paton JY, Grant S. Physical activity to prevent obesity in young children: cluster randomised controlled trial. BMJ. 2006 Nov 18;333(7577):1041. doi: 10.1136/bmj.38979.623773.55. Epub 2006 Oct 6.
- Background: PubMed 17899632Taylor RW, Mcauley KA, Williams SM, Barbezat W, Nielsen G, Mann JI. Reducing weight gain in children through enhancing physical activity and nutrition: the APPLE project. Int J Pediatr Obes. 2006;1(3):146-52. doi: 10.1080/17477160600881247.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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, Prof MD MSc study director
Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory parent-focused intervention and State-sponsored PA program in people with Obesity, run by Heidelberg University at 2 sites 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 2 inclusion and 5 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 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in physical activity as measured by accelerometry and heart rate (time frame: 0,6 and 12 months). 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 NCT01070251, 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 1 Aug 2012.