ObesityNCT00747513
A Multi-component Program to Reduce Obesity in Children
A study testing lifestyle program in people with Obesity, run by Sheba Medical Center at 22 sites in Israel.
Trial summary
In an attempt to challenge the increasing prevalence of childhood obesity, many programs have been executed in order to improve childrens' lifestyle. Programs involved either school, family or environmental measures. In most, success was only limited. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 22 sitesIsrael
- Study dates
- Sep 2009to 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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- schools with lunch served
- school principal agreement
- school has 2 weekly PE classes
- parent and children consent given
Who cannot join
- consent not given
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Israel22 sites
El Biader
Hura
El Magad
Hura
Harel Elementary School
Lod
Mabuim School
Merhavim
Merhavim School
Merhavim
Rothchild School
Or Akiva
Amirim School
Qiryat Yam
Miflasim School
Qiryat Yam
El Gazali
Rahat
Omar El Hatab
Rahat
Achva School
Ramla
Sharet Elementary School
Ramla
Fikus Preschool
Rosh HaAyin
Ilanot Preschol
Rosh HaAyin
Kinor Preschool
Rosh HaAyin
Meitar Preschool
Rosh HaAyin
Nevel Preschool
Rosh HaAyin
Teena Preschool
Rosh HaAyin
Maimon School
Shlomi
Hassan Arafe School
Tel Aviv
Lev Yafo School
Tel Aviv
Noam School
Tiberias
About this study
Official title: A Multi-component Program to Improve Lifestyle Habits and Reduce Obesity in Children
In an attempt to challenge the increasing prevalence of childhood obesity, many programs have been executed in order to improve childrens' lifestyle. Programs involved either school, family or environmental measures. In most, success was only limited.
The purpose of this trial is to examine the ability of a low-cost multi-component program to improve behavioral, diet and activity habits in both school, family and afternoon settings. Ths ultimate goal is to construct and assess a lifestyle modification program that can be implemented in schools and kindergartens on a national level.
Read more
Participants will be ~2,500 children aged 5-12 from 22 kindergartens and elementary schools, divided into control and intervention centers.
Teachers and students will be provided with materials in order to perform activities on healthy food and drink choices and habits during the school day. Schools will offer increased physical activity opportunities to children, as will afternoon community centers. Children will be given personal exercise items. Parents will be offered lectures on topics of diet and activity. Diet and activity habits will be assessed by a questionnaire, and height, weight and body fat percentage will be measured before and after the program.
- Conditions
- Obesity
- Being tested
- lifestyle program
- Keywords
- school, prevention, overweight, children, diet, physical activity, fitness
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle programBehavioural
a comprehensive program designed to encourage healthier food choices and eating habits and increased physical activity among children, by use of school, family and community measures.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | intervention group Receives: Behavioral: lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
screen time
Measured: 12 months
physical activity
Measured: 12 months
breakfast consumption
Measured: 12 months
eating family meals
Measured: 12 months
number of fruits and vegetables eaten per day
Measured: 12 months
drinking water
Measured: 12 months
body mass index
Measured: 12 months
Secondary outcomes (2)
body fat percentage
Measured: 12 months
daily dairy product intake
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 3,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Rashi Foundation, D-Cure, Israel
- Responsible party
- Sponsor
- Investigators
- Liat Lerner-geva, MD PhD, Principal investigator, Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747513
- Sponsor's protocol ID
- SHEBA- 08-5401-LL-CTIL
- Status last verified
- May 2012
- First submitted
- 4 Sep 2008
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-component Program to Improve Lifestyle Habits and Reduce Obesity in Children
- ClinicalTrials.gov ID
- NCT00747513
- Acronym / sponsor ID
- SHEBA- 08-5401-LL-CTIL
- Conditions
- Obesity
- Keywords
- school, prevention, overweight, children, diet, physical activity, fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,600 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Rashi Foundation, D-Cure, Israel
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Sep 2008 (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.
In an attempt to challenge the increasing prevalence of childhood obesity, many programs have been executed in order to improve childrens' lifestyle. Programs involved either school, family or environmental measures. In most, success was only limited.
The purpose of this trial is to examine the ability of a low-cost multi-component program to improve behavioral, diet and activity habits in both school, family and afternoon settings. Ths ultimate goal is to construct and assess a lifestyle modification program that can be implemented in schools and kindergartens on a national level.
Participants will be ~2,500 children aged 5-12 from 22 kindergartens and elementary schools, divided into control and intervention centers.
Teachers and students will be provided with materials in order to perform activities on healthy food and drink choices and habits during the school day. Schools will offer increased physical activity opportunities to children, as will afternoon community centers. Children will be given personal exercise items. Parents will be offered lectures on topics of diet and activity. Diet and activity habits will be assessed by a questionnaire, and height, weight and body fat percentage will be measured before and after the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: lifestyle programintervention group |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- schools with lunch served
- school principal agreement
- school has 2 weekly PE classes
- parent and children consent given
Key exclusion criteria (1 listed)
- consent not given
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 |
|---|---|---|
| lifestyle programa comprehensive program designed to encourage healthier food choices and eating habits and increased physical activity among children, by use of school, family and community measures. | Behavioural | I |
Primary outcome
screen time
Time frame: 12 months
physical activity
Time frame: 12 months
breakfast consumption
Time frame: 12 months
eating family meals
Time frame: 12 months
number of fruits and vegetables eaten per day
Time frame: 12 months
drinking water
Time frame: 12 months
body mass index
Time frame: 12 months
2 secondary outcomes
body fat percentage
Time frame: 12 months
daily dairy product intake
Time frame: 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 Jun 2012.
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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.
Liat Lerner-geva, MD PhD principal investigator
Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle program in people with Obesity, run by Sheba Medical Center at 22 sites in Israel.
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 4 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 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Israel. 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?
screen time (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2012.