Childhood ObesityNCT01578863
Predictors of Success in an Intervention Program for the Treatment of Childhood Obesity
A study testing Intervention program for obese children in people with Childhood Obesity, run by Meir Medical Center at 1 site in Israel.
Trial summary
The child health and sports center, at the Meir Medical Center, runs for over 10 years an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment. A similar program exists in the nearby city of Hadera. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Intervention program for obese children
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Apr 2015
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Obese / overweight children
Who cannot join
- Children that has an organic illness that cause obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Success in a Multidisciplinary Intervention Program for Obese Children and Adolescence
The child health and sports center, at the Meir Medical Center, runs for over 10 years an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment. A similar program exists in the nearby city of Hadera. The aim of the programs is to promote weight loss, encourage physical activity and modify behavior in order to get long term results. The aim of the present study is to try and identify the demographic and behavioral characteristics of children who succeed in the program.
- Conditions
- Childhood Obesity
- Being tested
- Intervention program for obese children
- Keywords
- Childhood obesity, Adolescence, Predictors, Success, Intervention program
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention program for obese childrenOther
Also called exercise, nutrition, behavioral
The program includes physical activity, nutrition intervention and behavioral treatment and lasts for 6 months. The aim of the program is to promote weight loss and physical activity and to promote future healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Intervention program | Active comparator | 6 months intervention program to lose weight in obese children. Behavioral, emotional, physical, familial and demographic questioners will be fulfilled at the beginning and at the end of the program. Receives: Other: Intervention program for obese children |
| Untreated obese children | No intervention | Behavioral, emotional, physical, familial and demographic questioners will be fulfilled twice in a 6 month program. |
| Normal weight children | No intervention | Behavioral, emotional, physical, familial and demographic questioners will fulfill twice in the 6 month period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of the children who succeed in the program
We will use behavioral, emotional, physical, familial and demographic questionnaires to characterize the children taking part in the programs.
The questionnaires: self-efficacy, motivation, depression, parenting style, demographic, environmental.Anthropometric and fitness measurements are performed on a monthly basis .
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Nemet, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578863
- Sponsor's protocol ID
- MeirMc009-12CTIL
- Status last verified
- May 2014
- First submitted
- 15 Mar 2012
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Success in a Multidisciplinary Intervention Program for Obese Children and Adolescence
- ClinicalTrials.gov ID
- NCT01578863
- Acronym / sponsor ID
- MeirMc009-12CTIL
- Conditions
- Childhood Obesity
- Keywords
- Childhood obesity, Adolescence, Predictors, Success, Intervention program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Apr 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.
The child health and sports center, at the Meir Medical Center, runs for over 10 years an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment. A similar program exists in the nearby city of Hadera. The aim of the programs is to promote weight loss, encourage physical activity and modify behavior in order to get long term results. The aim of the present study is to try and identify the demographic and behavioral characteristics of children who succeed in the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention program | Active comparator | Other: Intervention program for obese children6 months intervention program to lose weight in obese children. Behavioral, emotional, physical, familial and demographic questioners will be fulfilled at the beginning and at the end of the program. |
| Untreated obese children | No intervention | –Behavioral, emotional, physical, familial and demographic questioners will be fulfilled twice in a 6 month program. |
| Normal weight children | No intervention | –Behavioral, emotional, physical, familial and demographic questioners will fulfill twice in the 6 month period. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Obese / overweight children
Key exclusion criteria (1 listed)
- Children that has an organic illness that cause obesity
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 |
|---|---|---|
| Intervention program for obese childrenAlso: exercise, nutrition, behavioralThe program includes physical activity, nutrition intervention and behavioral treatment and lasts for 6 months. The aim of the program is to promote weight loss and physical activity and to promote future healthy lifestyle. | Other | Intervention program |
Primary outcome
Characteristics of the children who succeed in the program
Time frame: 6 Months
We will use behavioral, emotional, physical, familial and demographic questionnaires to characterize the children taking part in the programs. The questionnaires: self-efficacy, motivation, depression, parenting style, demographic, environmental.Anthropometric and fitness measurements are performed on a monthly basis .
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 14 Apr 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.
Dan Nemet, MD principal investigator
Meir 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 Intervention program for obese children in people with Childhood 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: finished, as of the sponsor's last update on 14 Apr 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?
Characteristics of the children who succeed in the program (time frame: 6 Months). 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 14 Apr 2015.