OverweightNCT01111812
Prediction of Weight Gain by Children and Adolescents
An observational study of Overweight and Obesity, run by Meir Medical Center at 1 site in Israel.
Trial summary
The 'Meir children's sport and health center' runs a multi-disciplinary intervention program for the treatment of overweight and obese children and adolescents. The program includes physical activity, dietary guidelines, medical supervision and behavioral treatment. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- How many people
- 530 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Nov 2017
- Phase
- Observational
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: overweight and obese children and adolescence, boys and girls, ages 5-18
Who may be able to join
- Overweight and obese children and adolescence
- Boys and girls
- Ages 5-18
- That taking pat in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Weight Gain by Children and Adolescents That Participate in a Multi-disciplinary Intervention Program for Treatment of Overweight and Obese
The 'Meir children's sport and health center' runs a multi-disciplinary intervention program for the treatment of overweight and obese children and adolescents. The program includes physical activity, dietary guidelines, medical supervision and behavioral treatment. The participants are routinely weighed once a week, at the same day and time, in order to supervise their progress. According to our experience, the child can predict his weight change, based on his "behavior" in the previous week. To our knowledge the overweight/obese child's ability to predict his weekly weight change, while participating in a multi-disciplinary intervention program, has never been tested.
Read the detailed description
The aim of this study is to examine whether a child participating in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center, can predict his weight change during intervention before the actual weighing.
This study will include 1000 weight measurements of children and adolescents, boys and girls, ages 5-18 years. A patient might be measured several times.
The data will be collected during 6 mounts. in this period the program participants will be asked, discretely, before being weighed if, in there opinion, they had lost or gained weight in the past week, and how mach and why.
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obese, children, weighing, weight
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| weight measurements | This study include 1000 weight measurements of children and adolescence, boys and girls, ages 5-18, that taking pat in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants will be able to predict their weight change
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 posted28 Apr 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2017
- Study completionNov 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Nemet, MD, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111812
- Sponsor's protocol ID
- MMC131-09CTIL
- Status last verified
- Nov 2017
- First submitted
- 26 Apr 2010
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Weight Gain by Children and Adolescents That Participate in a Multi-disciplinary Intervention Program for Treatment of Overweight and Obese
- ClinicalTrials.gov ID
- NCT01111812
- Acronym / sponsor ID
- MMC131-09CTIL
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obese, children, weighing, weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 28 Apr 2010 (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 'Meir children's sport and health center' runs a multi-disciplinary intervention program for the treatment of overweight and obese children and adolescents. The program includes physical activity, dietary guidelines, medical supervision and behavioral treatment. The participants are routinely weighed once a week, at the same day and time, in order to supervise their progress. According to our experience, the child can predict his weight change, based on his "behavior" in the previous week. To our knowledge the overweight/obese child's ability to predict his weekly weight change, while participating in a multi-disciplinary intervention program, has never been tested.
Detailed description
The aim of this study is to examine whether a child participating in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center, can predict his weight change during intervention before the actual weighing.
This study will include 1000 weight measurements of children and adolescents, boys and girls, ages 5-18 years. A patient might be measured several times.
The data will be collected during 6 mounts. in this period the program participants will be asked, discretely, before being weighed if, in there opinion, they had lost or gained weight in the past week, and how mach and why.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| weight measurements | – | –This study include 1000 weight measurements of children and adolescence, boys and girls, ages 5-18, that taking pat in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- overweight and obese children and adolescence, boys and girls, ages 5-18
Key inclusion criteria (4 listed)
- Overweight and obese children and adolescence
- Boys and girls
- Ages 5-18
- That taking pat in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants will be able to predict their weight change
Time frame: 6 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 21 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 inclusion and 0 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 21 Nov 2017. 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?
Participants will be able to predict their weight change (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 21 Nov 2017.