ObesityNCT01656928
Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters
A study testing preschool-based nutritional intervention in people with Obesity, run by Heidelberg University at 1 site in Germany.
Trial summary
This study assesses the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Obesity
- What is being tested?
- preschool-based nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteGermany
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pre-schools were eligible to participate in the study if they were located in one of three predefined regions and had applied to participate in the nutritional intervention module of a state-sponsored health promotion programme 'Komm mit in das gesunde Boot' ('Come aboard the health boat'), with at least fifteen children participating.
- Healthy children in eligible preschools
Who cannot join
- Age under 3 years or above 7 years
- Serious health problems
- Genetic conditions
- Metabolic diseases
- Acute infectious diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Mannheim Institute of Public Health, University of Heidelberg
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters: a Cluster-randomized Trial
This study assesses the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.
Read the detailed description
Objective: To assess the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.
Design: Using a cluster-randomized study design with waiting-list controls, we test a six-month intervention administered once weekly by a nutritional expert consisting of joint meal preparation and activities for children and parents like tasting and preparing nutritious, fresh foods. At baseline, six and twelve months, a parent-completed questionnaire assesses fruit and vegetable intake (primary outcomes) and water and sugared drink consumption (other outcomes). Direct measurement assessed BMI, percentage body fat (skin fold thicknesses) and waist-to-height-ratio. An intention-to-treat analysis used random effects panel regression models to assess the intervention effect, adjusted for each child's age, gender, immigrant background and maternal education.
Setting: 18 Preschools from three south German regions. Subjects: Healthy children from three to seven years of age.
- Conditions
- Obesity
- Being tested
- preschool-based nutritional intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preschool-based nutritional interventionBehavioural
Also called Nutritional Module of program "Komm mit in das gesunde Boot"
6-month intervention administered once weekly by a nutrition expert consisting of joint meal preparation and activities for children and parents such as tasting and preparing nutritious, fresh foods.
| Study group | Role | What they receive |
|---|---|---|
| Waiting-list control | Other | Allocation to waiting-list Control. Receives intervention 6 months later. Receives: Behavioral: preschool-based nutritional intervention |
| Intervention | Active comparator | Allocation to intervention. Directly starts with nutritional intervention. Receives: Behavioral: preschool-based nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fruit- and vegetable consumption
Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
Measured: 0, 6, 12 months
Secondary outcomes (3)
Change in Body Mass Index
Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
Measured: 0, 6, and 12 months
Change in Percent body fat
Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
Measured: 0, 6 and 12 months
Change in waist-to-height ratio
Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
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 posted3 Aug 2012 (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 (1)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
- 375 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, Professor Dr.med. MSc, Principal investigator, University of Heidelberg, Mannheim Institute of Pubic Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656928
- Sponsor's protocol ID
- CRTLasti_nutr_kiga
- Status last verified
- Jul 2012
- First submitted
- 27 Jul 2012
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
De Bock F, Breitenstein L, Fischer JE. Positive impact of a pre-school-based nutritional intervention on children's fruit and vegetable intake: results of a cluster-randomized trial. Public Health Nutr. 2012 Mar;15(3):466-75. doi: 10.1017/S136898001100200X. Epub 2011 Aug 23.
PubMed 21859516
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters: a Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT01656928
- Acronym / sponsor ID
- CRTLasti_nutr_kiga
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 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
- 3 Aug 2012 (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 assesses the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.
Detailed description
Objective: To assess the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.
Design: Using a cluster-randomized study design with waiting-list controls, we test a six-month intervention administered once weekly by a nutritional expert consisting of joint meal preparation and activities for children and parents like tasting and preparing nutritious, fresh foods. At baseline, six and twelve months, a parent-completed questionnaire assesses fruit and vegetable intake (primary outcomes) and water and sugared drink consumption (other outcomes). Direct measurement assessed BMI, percentage body fat (skin fold thicknesses) and waist-to-height-ratio. An intention-to-treat analysis used random effects panel regression models to assess the intervention effect, adjusted for each child's age, gender, immigrant background and maternal education.
Setting: 18 Preschools from three south German regions. Subjects: Healthy children from three to seven years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting-list control | Other | Behavioral: preschool-based nutritional interventionAllocation to waiting-list Control. Receives intervention 6 months later. |
| Intervention | Active comparator | Behavioral: preschool-based nutritional interventionAllocation to intervention. Directly starts with nutritional intervention. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pre-schools were eligible to participate in the study if they were located in one of three predefined regions and had applied to participate in the nutritional intervention module of a state-sponsored health promotion programme 'Komm mit in das gesunde Boot' ('Come aboard the health boat'), with at least fifteen children participating.
- Healthy children in eligible preschools
Key exclusion criteria (5 listed)
- Age under 3 years or above 7 years
- Serious health problems
- 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 |
|---|---|---|
| preschool-based nutritional interventionAlso: Nutritional Module of program "Komm mit in das gesunde Boot"6-month intervention administered once weekly by a nutrition expert consisting of joint meal preparation and activities for children and parents such as tasting and preparing nutritious, fresh foods. | Behavioural | Intervention, Waiting-list control |
Primary outcome
Change in Fruit- and vegetable consumption
Time frame: 0, 6, 12 months
Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
3 secondary outcomes
Change in Body Mass Index
Time frame: 0, 6, and 12 months
Change in Percent body fat
Time frame: 0, 6 and 12 months
Change in waist-to-height ratio
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 3 Aug 2012.
- Results publication: PubMed 21859516De Bock F, Breitenstein L, Fischer JE. Positive impact of a pre-school-based nutritional intervention on children's fruit and vegetable intake: results of a cluster-randomized trial. Public Health Nutr. 2012 Mar;15(3):466-75. doi: 10.1017/S136898001100200X. Epub 2011 Aug 23.
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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, Professor Dr.med. MSc principal investigator
University of Heidelberg, Mannheim Institute of Pubic Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preschool-based nutritional intervention in people with Obesity, run by Heidelberg University 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 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 3 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 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?
Change in Fruit- and vegetable consumption (time frame: 0, 6, 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 NCT01656928, 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 3 Aug 2012.