"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

Morbid Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102538
• Other study ID #: 0392-23-SMC
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Sheba Medical Center
• Contact: Orit Hamiel, Prof
• Phone: +972526667385
• Email: orit.hamiel[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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].

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 1. 6-minute walk test (6MWT) 2. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 30, 2024
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Behavioral:
• # 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

Locations

Country	Name	City	State
Israel	Endocrine and Diabetes Unit, Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	The change in weight from the baseline of the study to the end of the study	1 year
Primary	Psychological well-being - improvement in coherence	Sense of Coherence Scale - by Antonovsky	3 and 6 months
Secondary	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	3 and 6 months
Secondary	Improvement in physical fitness	Improvement in physical fitness; The 6-minute walking test (6MWT) - an acceptable walking test	3 and 6 months
Secondary	An increase in motivation for the IDF recruitment process	Number of participant who will eventually be recruited to the army	3 and 6 months
Secondary	Decrease in Depression	A decrease in the level of depression - Using PHQ9-	3 and 6 months
Secondary	Increase in social support	Scale of Perceiver Social Support MSPSS by (Ziment, Dahlem, Ziment and Fanley, 1988)	3 and 6 months
Secondary	Improvement in quality of life	Improvement in quality of life -Improvement in quality of life - (IWQOL-Kids)	3 and 6 months
Secondary	Improvement in self-efficacy -	Self Efficacy questionnaire by Chen, Gully and Eden 2001	3 and 6 months
Secondary	Balance test: testing balance	Dynamic balance test - Star Excursion Balance Test	3 and 6 months
Secondary	Balance test: testing balance time measurement.	Stork Balance Stand Test	3 and 6 months