Obesity4055obesityprvNCT00438555
Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children
A study testing Parents and children group and Parent's group in people with Obesity, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.Patients will be randomly allocated into one of two behavior intervention groups or control group in ratio of 1:1:1.The study will consist of two main periods: an intervention period of 3 months followed by 21 months of a… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Parents and children group and Parent's group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2006to Dec 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5-10 years old
- BMI in 85-98 percentile
- Both parents signing informed consent form
Who cannot join
- Chronic disease or chronic use of medication
- Incapability to perform all study procedure
Trial locations and contacts
1 site in 1 country.
About this study
Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.Patients will be randomly allocated into one of two behavior intervention groups or control group in ratio of 1:1:1.The study will consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in al 3 groups) at months 0, 3, 12 and 24.
Read the detailed description
Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.
Objectives:
- To develop an intervention program for obesity prevention in children aged 5-10 years old, who are at risk to develop obesity
- To compare between the efficacy of two different intervention programs and a control group in preventing obesity in the short and the long term.
- To evaluate the role and significance of including parents in an intervention program for obesity prevention.
- To identify demographic parameters, lifestyle characteristic and biochemical markers that predict the risk of developing obesity and the response for treatment.
Randomization:
Patients will be randomly allocated into one of two intervention groups or control group in ratio of 1:1:1. Each group will contain 12-15 participants.
Intervention groups:
- parent's group- only parents will take part at the intervention program.
- Parents and children group- both children and parents will take part at the intervention program, in two separate sessions.
Methods:
- The study will be consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in all 3 groups) at months 0, 3, 12 and 24.
- Height, weight, fat mass and waist circumference will be measured at 0, 3, 12 and 24 month. Height and weight of parents will also be measured at these visits.
- Physical examination will be performed at 0, 3, 12 and 24 month.
- Psychological and nutritional questionnaire (depression, quality of life and self estimation) will be filled at 0, 3, 12 and 24 month.
- Fasting blood tests for: chemistry, hematology, lipids, glucose, insulin, TSH, adiponectin, IL-6 and TNFα will be performed at 0, 3, 12 and 24 month.
- Conditions
- Obesity
- Being tested
- Parents and children group, Parent's group
- Keywords
- obesity,prevention,pediatric
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents and children groupBehavioural
3 months workshops of parents and children intervention, guided by dietician and phycologist
Parent's groupBehavioural
3 months workshop of parents intervention, guided by dietician and phycologist
| Study group | Role | What they receive |
|---|---|---|
| Parent's group | Experimental | 3 months workshop of parents intervention, guided by dietician and phycologist Receives: Behavioral: Parent's group |
| Parents and children group | Experimental | 3 months workshops of parents and children intervention, guided by dietician and phycologist Receives: Behavioral: Parents and children group |
| Control group | No intervention | control group, no intervention, medical follow up only |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startOct 2006
- Primary completionOct 2014
- Study completionDec 2014
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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, MD, Principal investigator, Schneider Children Medical CenterJoseph Meyerovitch, Dr, MD, Principal investigator, Schneider Children Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438555
- Sponsor's protocol ID
- rmc004055ctil
- Acronym
- 4055obesityprv
- Status last verified
- Jul 2014
- First submitted
- 21 Feb 2007
- Last updated
- 19 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children
- ClinicalTrials.gov ID
- NCT00438555
- Acronym / sponsor ID
- 4055obesityprv / rmc004055ctil
- Conditions
- Obesity
- Keywords
- obesity,prevention,pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2006
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Feb 2007 (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.
Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.Patients will be randomly allocated into one of two behavior intervention groups or control group in ratio of 1:1:1.The study will consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in al 3 groups) at months 0, 3, 12 and 24.
Detailed description
Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.
Objectives:
- To develop an intervention program for obesity prevention in children aged 5-10 years old, who are at risk to develop obesity
- To compare between the efficacy of two different intervention programs and a control group in preventing obesity in the short and the long term.
- To evaluate the role and significance of including parents in an intervention program for obesity prevention.
- To identify demographic parameters, lifestyle characteristic and biochemical markers that predict the risk of developing obesity and the response for treatment.
Randomization:
Patients will be randomly allocated into one of two intervention groups or control group in ratio of 1:1:1. Each group will contain 12-15 participants.
Intervention groups:
- parent's group- only parents will take part at the intervention program.
- Parents and children group- both children and parents will take part at the intervention program, in two separate sessions.
Methods:
- The study will be consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in all 3 groups) at months 0, 3, 12 and 24.
- Height, weight, fat mass and waist circumference will be measured at 0, 3, 12 and 24 month. Height and weight of parents will also be measured at these visits.
- Physical examination will be performed at 0, 3, 12 and 24 month.
- Psychological and nutritional questionnaire (depression, quality of life and self estimation) will be filled at 0, 3, 12 and 24 month.
- Fasting blood tests for: chemistry, hematology, lipids, glucose, insulin, TSH, adiponectin, IL-6 and TNFα will be performed at 0, 3, 12 and 24 month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parent's group | Experimental | Behavioral: Parent's group3 months workshop of parents intervention, guided by dietician and phycologist |
| Parents and children group | Experimental | Behavioral: Parents and children group3 months workshops of parents and children intervention, guided by dietician and phycologist |
| Control group | No intervention | –control group, no intervention, medical follow up only |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5-10 years old
- BMI in 85-98 percentile
- Both parents signing informed consent form
Key exclusion criteria (2 listed)
- Chronic disease or chronic use of medication
- Incapability to perform all study procedure
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 |
|---|---|---|
| Parents and children group3 months workshops of parents and children intervention, guided by dietician and phycologist | Behavioural | Parents and children group |
| Parent's group3 months workshop of parents intervention, guided by dietician and phycologist | Behavioural | Parent's group |
Primary outcome
BMI
Time frame: 24 month
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 19 Mar 2015.
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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.
Moshe Phillip, Prof, MD principal investigator
Schneider Children Medical Center
Joseph Meyerovitch, Dr, MD principal investigator
Schneider Children Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents and children group and Parent's group in people with Obesity, run by Rabin 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 3 inclusion and 2 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 19 Mar 2015. 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 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?
BMI (time frame: 24 month). 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 19 Mar 2015.