OverweightNCT01285063
Intervention Study for Overweight and Obese Kindergarten Children
A study testing Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment. in people with Overweight and Obesity, run by Meir Medical Center at 1 site in Israel.
Trial summary
The goal of the this study is to create an interdisciplinary program which includes intervention in the fields of nutrition, physical activity and behavior in order to treat obesity and overweight among kindergarten children and to examine the influence of such program on the BMI,BMI%, physical fitness, knowledge and… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Overweight, Obesity, Physical Fitness
- What is being tested?
- Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Feb 2014
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children in ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95).
Who cannot join
- children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
Israel1 site
the sports and health center for children and youth at "Meir" medical center
Kfar Saba
About this study
Official title: Combined Physical Activity and Diet Intervention for the Treatment of Overweight and Obesity in Kindergarten Children
The goal of the this study is to create an interdisciplinary program which includes intervention in the fields of nutrition, physical activity and behavior in order to treat obesity and overweight among kindergarten children and to examine the influence of such program on the BMI,BMI%, physical fitness, knowledge and preferences in the said fields among the participants.
Read the detailed description
Subjects, goals and objective:
Obesity is the most common chronic children disease of the modern era. The number of children who suffer from obesity is increasing to scales of epidemic. The frequency of obesity among kindergarten children (ages of 2-5) in the United States is approximately 14%, whereas among children of those ages in the center of Israel there is a risk of 25% to obesity and overweight.
Obesity is not only a cosmetic problem but also constitutes the #1 risk factor for common medical problems, such as: hyperlipidemia, high blood pressure, glucose intolerance, type 2 diabetes, arteriosclerosis, asthma, orthopaedic problems and psychological problems. A comprehensive review that was recently published showed that among fat children, intensive intervention programs which include nutrition consulting, physical training and behavioral change are the most effective to treat obesity.
Children who suffer from obesity have a greater risk to become fat adults and the older the child the greater the risk becomes. Therefore, it is highly important to treat such obesity in the youngest age possible. Moreover, along with the change of nutritious preferences, a great emphasize should be given to physical activity in order to reduce the BMI percentage and improve the physical fitness.
The goal of the paper is to create an interdisciplinary program which includes intervention in the fields of nutrition, physical activity and behavior in order to treat obesity and overweight among kindergarten children and to examine the influence of such program on the BMI,%BMI, physical fitness, knowledge and preferences in the said fields among the participants.
Place: The intervention program will be held in the sports and health center for children and youth at "Meir" medical center.
The intervention group: 25 kindergarten children in the ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95).
Non-generalization criteria: children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research.
The control group: 25 kindergarten children in similar ages who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95) and who do not participate in any intervention program.
The research plan Nutritious plan: includes 6 personal meetings, 30-45 minutes each, of the child and his parents with a dietician from the center. The meetings will include nutritious evaluation and will focus on nutritious education.
Physical activity: physical trainings of 45 minutes each will be held twice a week and be guided by a qualified trainer. In order to encourage the participants to take responsibility for the process, the children will be asked to further practice during the weeks and conduct little assignments which will be given by the trainer.
Additionally, all the participants will take part it a 45 minutes meeting of movement therapy once a week. Such meeting will be held by a qualified trainer. The goal of such meeting is to strengthen nutritious and physical activity habits and to assimilate positive change in the participants' lifestyle.
Evaluation index: height, weight, BMI and BMI percentage,"nutrition and physical activity knowledge and preferences" questionnaire. The questionnaire is an instrument to evaluate the knowledge and preferences of children in the ages of 4-8 in the fields of nutrition and physical activity.
Evaluation of physical fitness: "back and forth" running test for a 10m distance.
- Conditions
- Overweight, Obesity, Physical Fitness
- Being tested
- Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.
- Keywords
- overweight, obesity, physical fitness, kinder garden, preschool
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.Other
3 months intervention. Nutritious plan: includes 6 meetings of the child and his or her parents with a dietician from the center.
Physical activity: physical trainings of 60 minutes each will be held twice a week.
behavioral treatment: all the participants will take part it a 45 minutes meeting of movement therapy once a week. The goal of such meeting is to strengthen nutritious and physical activity habits and to assimilate positive change in the participants' lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| physical activiy & nutrition | Experimental | 25 kindergarten children in the ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95).
Non-generalization criteria: children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research. Receives: Other: Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of the BMI percentage among the participants in comparison to the control group.
height, weight, BMI and BMI percentage will be documented after each meeting with the dietitian.
Measured: every 2 weeks.
Secondary outcomes (2)
Improvement in the physical fitness of the participants in comparison to the control group.
"Back and forth" running test for a 10m distance.
Measured: Day 1 and after 3 months.
Positive change in the knowledge and preferences of the participants in the fields of nutrition and physical activity in comparison to the control group.
"Nutrition and physical activity knowledge and preferences" questionnaire. The questionnaire is an instrument to evaluate the knowledge and preferences of children in the ages of 4-8 in the fields of nutrition and physical activity.
Measured: Day 1 and after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: We were not successful in raising money for this project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tali Sinai, Dr, Study chair, The hebrew university, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285063
- Sponsor's protocol ID
- Mc01162010ctil
- Status last verified
- Feb 2013
- First submitted
- 7 Dec 2010
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Physical Activity and Diet Intervention for the Treatment of Overweight and Obesity in Kindergarten Children
- ClinicalTrials.gov ID
- NCT01285063
- Acronym / sponsor ID
- Mc01162010ctil
- Conditions
- Overweight, Obesity, Physical Fitness
- Keywords
- overweight, obesity, physical fitness, kinder garden, preschool
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were not successful in raising money for this project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 27 Jan 2011 (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 goal of the this study is to create an interdisciplinary program which includes intervention in the fields of nutrition, physical activity and behavior in order to treat obesity and overweight among kindergarten children and to examine the influence of such program on the BMI,BMI%, physical fitness, knowledge and preferences in the said fields among the participants.
Detailed description
Subjects, goals and objective:
Obesity is the most common chronic children disease of the modern era. The number of children who suffer from obesity is increasing to scales of epidemic. The frequency of obesity among kindergarten children (ages of 2-5) in the United States is approximately 14%, whereas among children of those ages in the center of Israel there is a risk of 25% to obesity and overweight.
Obesity is not only a cosmetic problem but also constitutes the #1 risk factor for common medical problems, such as: hyperlipidemia, high blood pressure, glucose intolerance, type 2 diabetes, arteriosclerosis, asthma, orthopaedic problems and psychological problems. A comprehensive review that was recently published showed that among fat children, intensive intervention programs which include nutrition consulting, physical training and behavioral change are the most effective to treat obesity.
Children who suffer from obesity have a greater risk to become fat adults and the older the child the greater the risk becomes. Therefore, it is highly important to treat such obesity in the youngest age possible. Moreover, along with the change of nutritious preferences, a great emphasize should be given to physical activity in order to reduce the BMI percentage and improve the physical fitness.
The goal of the paper is to create an interdisciplinary program which includes intervention in the fields of nutrition, physical activity and behavior in order to treat obesity and overweight among kindergarten children and to examine the influence of such program on the BMI,%BMI, physical fitness, knowledge and preferences in the said fields among the participants.
Place: The intervention program will be held in the sports and health center for children and youth at "Meir" medical center.
The intervention group: 25 kindergarten children in the ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95).
Non-generalization criteria: children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research.
The control group: 25 kindergarten children in similar ages who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95) and who do not participate in any intervention program.
The research plan Nutritious plan: includes 6 personal meetings, 30-45 minutes each, of the child and his parents with a dietician from the center. The meetings will include nutritious evaluation and will focus on nutritious education.
Physical activity: physical trainings of 45 minutes each will be held twice a week and be guided by a qualified trainer. In order to encourage the participants to take responsibility for the process, the children will be asked to further practice during the weeks and conduct little assignments which will be given by the trainer.
Additionally, all the participants will take part it a 45 minutes meeting of movement therapy once a week. Such meeting will be held by a qualified trainer. The goal of such meeting is to strengthen nutritious and physical activity habits and to assimilate positive change in the participants' lifestyle.
Evaluation index: height, weight, BMI and BMI percentage,"nutrition and physical activity knowledge and preferences" questionnaire. The questionnaire is an instrument to evaluate the knowledge and preferences of children in the ages of 4-8 in the fields of nutrition and physical activity.
Evaluation of physical fitness: "back and forth" running test for a 10m distance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physical activiy & nutrition | Experimental | Other: Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.25 kindergarten children in the ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95). Non-generalization criteria: children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children in ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95).
Key exclusion criteria (1 listed)
- children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research.
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 |
|---|---|---|
| Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.3 months intervention. Nutritious plan: includes 6 meetings of the child and his or her parents with a dietician from the center. Physical activity: physical trainings of 60 minutes each will be held twice a week. behavioral treatment: all the participants will take part it a 45 minutes meeting of movement therapy once a week. The goal of such meeting is to strengthen nutritious and physical activity habits and to assimilate positive change in the participants' lifestyle. | Other | physical activiy & nutrition |
Primary outcome
reduction of the BMI percentage among the participants in comparison to the control group.
Time frame: every 2 weeks.
height, weight, BMI and BMI percentage will be documented after each meeting with the dietitian.
2 secondary outcomes
Improvement in the physical fitness of the participants in comparison to the control group.
Time frame: Day 1 and after 3 months.
Positive change in the knowledge and preferences of the participants in the fields of nutrition and physical activity in comparison to the control group.
Time frame: Day 1 and after 3 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
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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.
Tali Sinai, Dr study chair
The hebrew university, Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment. in people with Overweight and Obesity, run by Meir Medical Center at 1 site 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 1 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: withdrawn, as of the sponsor's last update on 21 Feb 2013. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
reduction of the BMI percentage among the participants in comparison to the control group. (time frame: every 2 weeks.). 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 21 Feb 2013; AzTrials last refreshed its copy on 31 Oct 2026.