ObesityNCT01534091
Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time
A study testing Pedometer with supervision and Pedometer without supervision in people with Obesity, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine if internet supervised by pedometer will contribute to enhance the amount of physical activity at leisure time by obese children. The investigators hypothesize that using pedometer will increase the amount of physical activity done by obese children in the afternoon and will… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- Pedometer with supervision and Pedometer without supervision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Dec 2013
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- overweight/obese children
- age 5-18
- boys and girls
Who cannot join
- children with genetic obesity or obesity cased by a disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine if internet supervised by pedometer will contribute to enhance the amount of physical activity at leisure time by obese children.
The investigators hypothesize that using pedometer will increase the amount of physical activity done by obese children in the afternoon and will improve the likelihood of success in the intervention program.
Read the detailed description
Childhood overweight \& obesity is the most common chronic disease in the western society. The prevalence of childhood obesity in Israel is among the highest in Europe. Recent data suggest that the recommended treatment for childhood obesity should be intense, multi-disciplinary intervention, including dietary, behavioral and physical activity components. Such a program exists at the Meir Medical Center in Israel for a few years with promising results.
The program includes: physical activity(PA)exercise (twice a week/1h), dietary guidance, medical supervision and behavioral intervention. The participants are asked to enhance PA at their leisure time, and to report to their coaches. Yet, the amount of time they actually exercise is not controled by us.
This study will include 3 groups of overweight\& obese children:
- Intervention with pedometers and supervision.
- Intervention with pedometer without supervision.
- Control. Obese and overweight children not taking part in a treatment program.
- Conditions
- Obesity
- Being tested
- Pedometer with supervision, Pedometer without supervision
- Keywords
- overweight, obese, children, exercise, physical activity, pedometer
- 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.
Pedometer with supervisionBehavioural
Also called exercise + diet + pedometer
Pedometer without supervisionBehavioural
Also called exercise + diet + closed pedometer
| Study group | Role | What they receive |
|---|---|---|
| Pedometer with supervision | Active comparator | Participants will get pedometers to evaluate their daily PA. The sport center stuff will review the child weekly reports, guide the child, encourage him and supervise that the recommended PA level is achieved. Receives: Behavioral: Pedometer with supervision |
| Pedometer without supervision | Active comparator | Participants will get pedometers to evaluate their daily PA. The sport center stuff won't give any recommendation or supervision for PA level. Receives: Behavioral: Pedometer without supervision |
| Control group | No intervention | Overweight \& obese children not participating in an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in BMI percentiles
BMI percentiles will be calculated at the beginning and in the end of the study
Measured: 3 months
Secondary outcomes (1)
Aerobic fitness
15 minutes of running or walking test
Measured: 3 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2013
- Study completionDec 2013
Why it stopped: Lack of cooperation by the participants
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Nemet, Prof. MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534091
- Sponsor's protocol ID
- MeirMc02711CTIL
- Status last verified
- Oct 2013
- First submitted
- 18 Jan 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
- Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time
- ClinicalTrials.gov ID
- NCT01534091
- Acronym / sponsor ID
- MeirMc02711CTIL
- Conditions
- Obesity
- Keywords
- overweight, obese, children, exercise, physical activity, pedometer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of cooperation by the participants
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Feb 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 purpose of this study is to examine if internet supervised by pedometer will contribute to enhance the amount of physical activity at leisure time by obese children.
The investigators hypothesize that using pedometer will increase the amount of physical activity done by obese children in the afternoon and will improve the likelihood of success in the intervention program.
Detailed description
Childhood overweight \& obesity is the most common chronic disease in the western society. The prevalence of childhood obesity in Israel is among the highest in Europe. Recent data suggest that the recommended treatment for childhood obesity should be intense, multi-disciplinary intervention, including dietary, behavioral and physical activity components. Such a program exists at the Meir Medical Center in Israel for a few years with promising results.
The program includes: physical activity(PA)exercise (twice a week/1h), dietary guidance, medical supervision and behavioral intervention. The participants are asked to enhance PA at their leisure time, and to report to their coaches. Yet, the amount of time they actually exercise is not controled by us.
This study will include 3 groups of overweight\& obese children:
- Intervention with pedometers and supervision.
- Intervention with pedometer without supervision.
- Control. Obese and overweight children not taking part in a treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pedometer with supervision | Active comparator | Behavioral: Pedometer with supervisionParticipants will get pedometers to evaluate their daily PA. The sport center stuff will review the child weekly reports, guide the child, encourage him and supervise that the recommended PA level is achieved. |
| Pedometer without supervision | Active comparator | Behavioral: Pedometer without supervisionParticipants will get pedometers to evaluate their daily PA. The sport center stuff won't give any recommendation or supervision for PA level. |
| Control group | No intervention | –Overweight \& obese children not participating in an intervention. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- overweight/obese children
- age 5-18
- boys and girls
Key exclusion criteria (1 listed)
- children with genetic obesity or obesity cased by a disease
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 |
|---|---|---|
| Pedometer with supervisionAlso: exercise + diet + pedometer | Behavioural | Pedometer with supervision |
| Pedometer without supervisionAlso: exercise + diet + closed pedometer | Behavioural | Pedometer without supervision |
Primary outcome
Decline in BMI percentiles
Time frame: 3 months
BMI percentiles will be calculated at the beginning and in the end of the study
1 secondary outcome
Aerobic fitness
Time frame: 3 months intervention
Results and safety
The study was stopped early (reason given: Lack of cooperation by the participants). Results are not available in the source record.
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, Prof. 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 Pedometer with supervision and Pedometer without supervision in people with 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 3 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: stopped early, 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 was stopped early (reason given: Lack of cooperation by the participants). Results are not available in the source record.
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?
Decline in BMI percentiles (time frame: 3 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.