ObesityNCT01555034
Movement Therapy and Childhood Obesity
A study testing movement therapy and exercise plus nutrition in people with Obesity, run by Meir Medical Center at 1 site in Israel.
Trial summary
The Child health and Sports Center, Meir Medical Center, has an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment.The emphasis given in the center to physical activity and sport enables a strong connection with movement therapy. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- movement therapy and exercise plus nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Overweight/obese children
Who cannot join
- Child that do not want to take part in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Movement Therapy on the Success in a Multidisciplinary Intervention for the Treatment of Childhood Obesity
The Child health and Sports Center, Meir Medical Center, has an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment.The emphasis given in the center to physical activity and sport enables a strong connection with movement therapy. Movement therapy allows obese children to face and cope with the psychological and emotional aspects of obesity.
The purpose of this study is to evaluate the contribution of the movement therapy intervention to our program.
Read the detailed description
Movement therapy is part of the multidisciplinary intervention. Weekly one hour long sessions are conducted under the guidance of a certified therapists.
The meeting includes physical movement aimed to address the emotional world of the obese child. Using games, structured exercises and verbal processing.
At the start and end of the evaluation the children will answer questionnaires to study:
- Behavioral questionnaires:emotional state: anxiety, depression, communication, self-esteem, quality of life and self-efficacy.
- Demographic questions . At the beginning and the end of the program a certified movement therapist will observe the children to estimate the change of emotional movement.weight, height and BMI are measured regularly in the center.
- Conditions
- Obesity
- Being tested
- movement therapy, exercise plus nutrition
- Keywords
- obesity, movement therapy, exercise, behaviour
- Medical subject headings
- Obesity, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
movement therapyBehavioural
exercise, nutrition, movement therapy
exercise plus nutritionOther
exercise, nutrition
| Study group | Role | What they receive |
|---|---|---|
| intervention plus therapy | Active comparator | Not described Receives: Behavioral: movement therapy |
| intervention no therapy | Active comparator | exercise and nutrition Receives: Other: exercise plus nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional/behavioral changes
Change from Baseline in emotional and behavioral questioners at 3 months. The questioners: depression, anxiety, self-efficacy, self-esteem, attachment and quality of life.
Measured: 3 MONTHS
Secondary outcomes (1)
weight, height and BMI
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startApr 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 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
- 26 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
- NCT01555034
- Sponsor's protocol ID
- 016111CTIL
- Status last verified
- Mar 2014
- First submitted
- 8 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
- The Effect of Movement Therapy on the Success in a Multidisciplinary Intervention for the Treatment of Childhood Obesity
- ClinicalTrials.gov ID
- NCT01555034
- Acronym / sponsor ID
- 016111CTIL
- Conditions
- Obesity
- Keywords
- obesity, movement therapy, exercise, behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Mar 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, Meir Medical Center, has an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment.The emphasis given in the center to physical activity and sport enables a strong connection with movement therapy. Movement therapy allows obese children to face and cope with the psychological and emotional aspects of obesity.
The purpose of this study is to evaluate the contribution of the movement therapy intervention to our program.
Detailed description
Movement therapy is part of the multidisciplinary intervention. Weekly one hour long sessions are conducted under the guidance of a certified therapists.
The meeting includes physical movement aimed to address the emotional world of the obese child. Using games, structured exercises and verbal processing.
At the start and end of the evaluation the children will answer questionnaires to study:
- Behavioral questionnaires:emotional state: anxiety, depression, communication, self-esteem, quality of life and self-efficacy.
- Demographic questions . At the beginning and the end of the program a certified movement therapist will observe the children to estimate the change of emotional movement.weight, height and BMI are measured regularly in the center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention plus therapy | Active comparator | Behavioral: movement therapy |
| intervention no therapy | Active comparator | Other: exercise plus nutritionexercise and nutrition |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Overweight/obese children
Key exclusion criteria (1 listed)
- Child that do not want to take part in this study
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 |
|---|---|---|
| movement therapyexercise, nutrition, movement therapy | Behavioural | intervention plus therapy |
| exercise plus nutritionexercise, nutrition | Other | intervention no therapy |
Primary outcome
Emotional/behavioral changes
Time frame: 3 MONTHS
Change from Baseline in emotional and behavioral questioners at 3 months. The questioners: depression, anxiety, self-efficacy, self-esteem, attachment and quality of life.
1 secondary outcome
weight, height and BMI
Time frame: 3 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 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 movement therapy and exercise plus nutrition 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 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?
Emotional/behavioral changes (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.