Childhood ObesityNCT03165604
The Effect of Information on Physical Fitness Measures and Training in Overweight Children
A study testing standard information and positive information in people with Childhood Obesity, run by Meir Medical Center at 1 site in Israel.
Trial summary
In the present study the investigators will examine the impact of varying information (positive compared to standard information) concerning a drink for improving physical fitness in overweight children. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- standard information and positive information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2017to 3 Oct 2018
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pre pubertal children
- Study group: BMI precentiles over 85 (overweight and obese children)
- Control group: BMI precentiles between 5-85 (normal weight children)
Who cannot join
- Children with organic Disease
- Competitive athlete
Trial locations and contacts
1 site in 1 country.
About this study
In the present study the investigators will examine the impact of varying information (positive compared to standard information) concerning a drink for improving physical fitness in overweight children.
Read the detailed description
The present study will explore the short and medium term effects of receiving information concerning a drink (water) (positive compared to standard information) on the physical fitness in overweight children.
Study subjects will be 30 overweight children aged 6 to 13, new participates in a nutritional, behavioral sport program,The control group of 30 normal weight children.
The first stage of the study the investigators will examine the short-term influence of different types of information concerning water on subjects' fitness which will be measured by treadmill performance. First, the water will be presented to the participants children as an ordinary water while in the second case it will be presented as an "energy drink".
The second stage of the study will examine the impact of varying information on the subjects' sports participation/level of physical activity over a 6 week period of training, Study subjects will be 30 over-weight children aged 6 to 13, who participate in a nutritional, behavioral sport program. During this period, information on the type of drink will be changed every week. Children will be assessed in all training sessions and their level of activity will be monitored to examine whether the information on the drink led to a different exercise behavior.
The study hypothesis is that the use of these positive information will increase participants' fitness and levels of activity compared to standard information.
- Conditions
- Childhood Obesity
- Being tested
- standard information, positive information
- Keywords
- Physical fitness, Exercise, Childhood Obesity, Information
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard informationOther
The participates will be given a standard information regarding the water drink before physical activity
positive informationOther
The participates will be given positive information (the drink will be presented as an "energy" drink) regarding the drink before physical activity
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Active comparator | 30 normal weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise Receives: Other: standard information; Other: positive information |
| Over weight | Active comparator | 30 over weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise Receives: Other: standard information; Other: positive information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running time (seconds)
Overall running time during aerobic treadmill fitness test
Measured: up to 6 weeks
Secondary outcomes (1)
Maximal heart rate (beats/min)
Maximal heart rate during aerobic treadmill fitness test
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jul 2017
- Primary completion1 Oct 2018
- Study completion3 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 54 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
- NCT03165604
- Sponsor's protocol ID
- MeirMc0017-17CTIL
- Status last verified
- Dec 2018
- First submitted
- 18 Apr 2017
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fanti-Oren S, Birenbaum-Carmeli D, Eliakim A, Pantanowitz M, Nemet D. The effect of placebo on endurance capacity in normal weight children - a randomized trial. BMC Pediatr. 2019 Jan 10;19(1):15. doi: 10.1186/s12887-019-1394-x.
PubMed 30630461
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Information on Physical Fitness Measures and Training in Overweight Children
- ClinicalTrials.gov ID
- NCT03165604
- Acronym / sponsor ID
- MeirMc0017-17CTIL
- Conditions
- Childhood Obesity
- Keywords
- Physical fitness, Exercise, Childhood Obesity, Information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 24 May 2017 (actual)
- 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.
In the present study the investigators will examine the impact of varying information (positive compared to standard information) concerning a drink for improving physical fitness in overweight children.
Detailed description
The present study will explore the short and medium term effects of receiving information concerning a drink (water) (positive compared to standard information) on the physical fitness in overweight children.
Study subjects will be 30 overweight children aged 6 to 13, new participates in a nutritional, behavioral sport program,The control group of 30 normal weight children.
The first stage of the study the investigators will examine the short-term influence of different types of information concerning water on subjects' fitness which will be measured by treadmill performance. First, the water will be presented to the participants children as an ordinary water while in the second case it will be presented as an "energy drink".
The second stage of the study will examine the impact of varying information on the subjects' sports participation/level of physical activity over a 6 week period of training, Study subjects will be 30 over-weight children aged 6 to 13, who participate in a nutritional, behavioral sport program. During this period, information on the type of drink will be changed every week. Children will be assessed in all training sessions and their level of activity will be monitored to examine whether the information on the drink led to a different exercise behavior.
The study hypothesis is that the use of these positive information will increase participants' fitness and levels of activity compared to standard information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | Active comparator | Other: standard information, Other: positive information30 normal weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise |
| Over weight | Active comparator | Other: standard information, Other: positive information30 over weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pre pubertal children
- Study group: BMI precentiles over 85 (overweight and obese children)
- Control group: BMI precentiles between 5-85 (normal weight children)
Key exclusion criteria (2 listed)
- Children with organic Disease
- Competitive athlete
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 |
|---|---|---|
| standard informationThe participates will be given a standard information regarding the water drink before physical activity | Other | Normal weight, Over weight |
| positive informationThe participates will be given positive information (the drink will be presented as an "energy" drink) regarding the drink before physical activity | Other | Normal weight, Over weight |
Primary outcome
Running time (seconds)
Time frame: up to 6 weeks
Overall running time during aerobic treadmill fitness test
1 secondary outcome
Maximal heart rate (beats/min)
Time frame: up to 6 weeks
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 6 Dec 2018.
- Derived from this study: PubMed 30630461Fanti-Oren S, Birenbaum-Carmeli D, Eliakim A, Pantanowitz M, Nemet D. The effect of placebo on endurance capacity in normal weight children - a randomized trial. BMC Pediatr. 2019 Jan 10;19(1):15. doi: 10.1186/s12887-019-1394-x.
- Individual participant dataSharing planned: No
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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 standard information and positive information 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 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 6 Dec 2018. 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?
Running time (seconds) (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03165604, which also lists 1 linked publication.
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 6 Dec 2018.