Morbid ObesityNCT06102538
"Hachi Barie" Project - A Multidisciplinary Program to Accompany Severely Obese Teenagers in the Weight Loss Process for the Benefit of Their Recruitment Into the Israel Defense Forces
A study testing # The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological support in people with Morbid Obesity, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Teenagers with body mass values (BMI) above 35 kg/m2 and co-morbidity are designated for medical disqualification from service in the IDF. Data show that there has been an increase in the incidence of these teenagers, specifically among the lower socioeconomic status. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- # The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological support
- 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
- 9 Oct 2023to 30 Dec 2024
- 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 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Boys and girls ages 15 -19 years
- Obesity - BMI >30-40 Kg/m2
- Additional morbidity ( Type 2 diabetes, Hypertension)
- A basic state of health that allows participation in the program.
- Boys and girls who have their own and their family's willingness and commitment to participate in the process
- Expected to be exempt from enlistment in the IDF
Who cannot join
- retardation
- a syndrome that does not allow integration into the group
- significant morbidity that prevents physical activity according to the decision of the attending physician.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Endocrine and Diabetes Unit, Sheba Medical Center
Ramat Gan, 52621
Orit Pinhas-Hamiel, MD, 972-526667385, orit.hamiel@sheba.healtg.gov.il
About this study
Teenagers with body mass values (BMI) above 35 kg/m2 and co-morbidity are designated for medical disqualification from service in the IDF. Data show that there has been an increase in the incidence of these teenagers, specifically among the lower socioeconomic status. The purpose of this pilot study is to carry out an intervention Based lifestyle modification among a group of boys and girls with morbid obesity accompanied by a comorbidity that disqualifies them from service in the IDF.
Definition of success: meeting the threshold of weight and health status that allows recruitment into the IDF.
Read more
Criteria for finding candidates:
- Boys and girls from the age of 15 who suffer from morbid obesity and comorbidity that may prevent their enlistment in the IDF. (This age range was chosen to allow an ideal period of at least one year to make a significant change).
- Boys and girls who have their own and their family's willingness and commitment to participate in the process
- A basic state of health that allows participation in the program. The screening process will be done by the staff of the endocrine unit, under the management of Prof. Orit Pinhas-Hamiel.
Duration of intervention:
26 weekly sessions for the trainees. The duration of the meeting will be about three hours in the afternoon A decision whether to extend the duration of the intervention will be taken according to the initial results of the program.
Activity location:
Potential sites vary: Sheba// academic complex // military base for trainees. Number of participants - 25, (dropout expected 30%) Research goals (main content elements in the program) - there are 3 main content areas (of similar importance)
- Education about the importance of service in the IDF and the opportunities inherent in it
- Ability-adapted physical activity education and training
- Guidance for a healthy diet
- Psychological support [The medical accompaniment to the program will take place on the basis of the patients' mother clinics and the medical follow-up of them will be done separately].
Read the detailed description
The purpose of the program:
- Readiness for recruitment into the IDF, both in terms of recruitment criteria, and in terms of motivation
- Candidates: teenagers aged 15 and over, who, based on their weight and associated morbidity, can be assumed to be exempt from conscription. Boys and girls motivated for change.
Half-yearly program (26 sessions) with an option to extend.
- The location of the activity. Closed meetings at the college in Kiryat Ono, meetings will also be planned at the Wingit Institute, and at the IDF base (if possible).
- Number of participants for the initial pilot about 25 participants. More groups will be opened later.
- Before the start, the candidates will be screened by psychologists from the pediatric endocrinology unit,
- Before the start, the candidates will undergo a comprehensive medical examination by a pediatrician and endocrinologist, which will include height, weight, blood pressure test, waist circumference, Bio-Impedence
- In the first and last meeting, the physical ability will be assessed by me
- 6-minute walk test (6MWT)
- Balance tests
- Dynamic balance test - star excursion balance test
- Stork Balance Stand Test, time measurement. 3. Muscle strength tests: pressing force with a hand dynamometer. Questionnaires
- In the first and last meeting the participants will fill
- Questionnaires of eating habits FFQ, as well as pickiness in food
- Questionnaires about motivation, self-efficacy, depression
- Conditions
- Morbid Obesity
- Being tested
- # The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological support
- Keywords
- morbid obesity
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
# The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological supportBehavioural
# Education for the importance of service in the IDF # Education and training for physical activity adapted to abilities # Training for a healthy diet # Psychological support
| Study group | Role | What they receive |
|---|---|---|
| Morbid obese adolescents with comorbidity | Active comparator | A weekly intervention of physical education, group psychological support, and nutrition education. Receives: Behavioral: # The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological support |
| Obese children who do not participate in this intervention | No intervention | This group of adolescents will continue the routine treatment in the clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The change in weight from the baseline of the study to the end of the study
Measured: 1 year
Psychological well-being - improvement in coherence
Sense of Coherence Scale - by Antonovsky
Measured: 3 and 6 months
Secondary outcomes (9)
Improving eating habits
Eating habits Food frequency Questionnaire (FFQ) A screening questionnaire adapted to Israel for food consumption according to the principles of the Mediterranean diet -I-MEDAS Israeli MABAT Questionnaire - Israeli Ministry of Health
Measured: 3 and 6 months
Improvement in physical fitness
Improvement in physical fitness
The 6-minute walking test (6MWT) - an acceptable walking test
Measured: 3 and 6 months
An increase in motivation for the IDF recruitment process
Number of participant who will eventually be recruited to the army
Measured: 3 and 6 months
Decrease in Depression
A decrease in the level of depression - Using PHQ9-
Measured: 3 and 6 months
Increase in social support
Scale of Perceiver Social Support MSPSS by (Ziment, Dahlem, Ziment and Fanley, 1988)
Measured: 3 and 6 months
Improvement in quality of life
Improvement in quality of life -Improvement in quality of life - (IWQOL-Kids)
Measured: 3 and 6 months
Improvement in self-efficacy -
Self Efficacy questionnaire by Chen, Gully and Eden 2001
Measured: 3 and 6 months
Balance test: testing balance
Dynamic balance test - Star Excursion Balance Test
Measured: 3 and 6 months
Balance test: testing balance time measurement.
Stork Balance Stand Test
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start9 Oct 2023
- Primary completion10 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Single group
- Model description
- The structure of the meetings - once a week 1. An hour and a half of physical activity adapted to the ability of teenagers with morbid obesity. 2. An hour and a half of training and education, which will include: * 10 group sessions with a dietician 45 minutes each session * 10 group meetings with a mental health staff member, 45 minutes per meeting (at least two of the meetings will be designated for a joint cooking workshop with the parents) * 6 meetings with IDF personnel, value meetings: the structure of the army, integration into the army, etc. 3. Meetings for parents - will include guidance from a nutritionist, exercise for parents, resilience for parents.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Orit Hamiel, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102538
- Sponsor's protocol ID
- 0392-23-SMC
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Hachi Barie" Project - A Multidisciplinary Program to Accompany Severely Obese Teenagers in the Weight Loss Process for the Benefit of Their Recruitment Into the Israel Defense Forces
- ClinicalTrials.gov ID
- NCT06102538
- Acronym / sponsor ID
- 0392-23-SMC
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Oct 2023 (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.
Teenagers with body mass values (BMI) above 35 kg/m2 and co-morbidity are designated for medical disqualification from service in the IDF. Data show that there has been an increase in the incidence of these teenagers, specifically among the lower socioeconomic status. The purpose of this pilot study is to carry out an intervention Based lifestyle modification among a group of boys and girls with morbid obesity accompanied by a comorbidity that disqualifies them from service in the IDF.
Definition of success: meeting the threshold of weight and health status that allows recruitment into the IDF.
Criteria for finding candidates:
- Boys and girls from the age of 15 who suffer from morbid obesity and comorbidity that may prevent their enlistment in the IDF. (This age range was chosen to allow an ideal period of at least one year to make a significant change).
- Boys and girls who have their own and their family's willingness and commitment to participate in the process
- A basic state of health that allows participation in the program. The screening process will be done by the staff of the endocrine unit, under the management of Prof. Orit Pinhas-Hamiel.
Duration of intervention:
26 weekly sessions for the trainees. The duration of the meeting will be about three hours in the afternoon A decision whether to extend the duration of the intervention will be taken according to the initial results of the program.
Activity location:
Potential sites vary: Sheba// academic complex // military base for trainees. Number of participants - 25, (dropout expected 30%) Research goals (main content elements in the program) - there are 3 main content areas (of similar importance)
- Education about the importance of service in the IDF and the opportunities inherent in it
- Ability-adapted physical activity education and training
- Guidance for a healthy diet
- Psychological support [The medical accompaniment to the program will take place on the basis of the patients' mother clinics and the medical follow-up of them will be done separately].
Detailed description
The purpose of the program:
- Readiness for recruitment into the IDF, both in terms of recruitment criteria, and in terms of motivation
- Candidates: teenagers aged 15 and over, who, based on their weight and associated morbidity, can be assumed to be exempt from conscription. Boys and girls motivated for change.
Half-yearly program (26 sessions) with an option to extend.
- The location of the activity. Closed meetings at the college in Kiryat Ono, meetings will also be planned at the Wingit Institute, and at the IDF base (if possible).
- Number of participants for the initial pilot about 25 participants. More groups will be opened later.
- Before the start, the candidates will be screened by psychologists from the pediatric endocrinology unit,
- Before the start, the candidates will undergo a comprehensive medical examination by a pediatrician and endocrinologist, which will include height, weight, blood pressure test, waist circumference, Bio-Impedence
- In the first and last meeting, the physical ability will be assessed by me
- 6-minute walk test (6MWT)
- Balance tests
- Dynamic balance test - star excursion balance test
- Stork Balance Stand Test, time measurement. 3. Muscle strength tests: pressing force with a hand dynamometer. Questionnaires
- In the first and last meeting the participants will fill
- Questionnaires of eating habits FFQ, as well as pickiness in food
- Questionnaires about motivation, self-efficacy, depression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The structure of the meetings - once a week 1. An hour and a half of physical activity adapted to the ability of teenagers with morbid obesity. 2. An hour and a half of training and education, which will include: * 10 group sessions with a dietician 45 minutes each session * 10 group meetings with a mental health staff member, 45 minutes per meeting (at least two of the meetings will be designated for a joint cooking workshop with the parents) * 6 meetings with IDF personnel, value meetings: the structure of the army, integration into the army, etc. 3. Meetings for parents - will include guidance from a nutritionist, exercise for parents, resilience for parents.
| Arm | Type | Receives |
|---|---|---|
| Morbid obese adolescents with comorbidity | Active comparator | Behavioral: # The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological supportA weekly intervention of physical education, group psychological support, and nutrition education. |
| Obese children who do not participate in this intervention | No intervention | –This group of adolescents will continue the routine treatment in the clinic |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Boys and girls ages 15 -19 years
- Obesity - BMI >30-40 Kg/m2
- Additional morbidity ( Type 2 diabetes, Hypertension)
- A basic state of health that allows participation in the program.
- Boys and girls who have their own and their family's willingness and commitment to participate in the process
Key exclusion criteria (3 listed)
- retardation
- a syndrome that does not allow integration into the group
- significant morbidity that prevents physical activity according to the decision of the attending physician.
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 |
|---|---|---|
| # The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological support# Education for the importance of service in the IDF # Education and training for physical activity adapted to abilities # Training for a healthy diet # Psychological support | Behavioural | Morbid obese adolescents with comorbidity |
Primary outcome
Weight loss
Time frame: 1 year
The change in weight from the baseline of the study to the end of the study
Psychological well-being - improvement in coherence
Time frame: 3 and 6 months
Sense of Coherence Scale - by Antonovsky
9 secondary outcomes
Improving eating habits
Time frame: 3 and 6 months
Improvement in physical fitness
Time frame: 3 and 6 months
An increase in motivation for the IDF recruitment process
Time frame: 3 and 6 months
Decrease in Depression
Time frame: 3 and 6 months
Increase in social support
Time frame: 3 and 6 months
Improvement in quality of life
Time frame: 3 and 6 months
Improvement in self-efficacy -
Time frame: 3 and 6 months
Balance test: testing balance
Time frame: 3 and 6 months
Balance test: testing balance time measurement.
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing # The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological support in people with Morbid Obesity, run by Sheba 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orit Hamiel, Prof (+972526667385, orit.hamiel@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 1 year). The study lists 2 primary outcomes in all. 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 26 Oct 2023.