"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

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].

Study Overview

• Status: Recruiting
• Conditions: Morbid Obesity
• Intervention / Treatment: Behavioral: # The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological support

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

  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

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Orit Hamiel, Prof; Phone Number: +972526667385; Email: orit.hamiel@sheba.health.gov.il
• Study Contact Backup: Name: Moran Shemesh- Iron, MA; Phone Number: +972542475008; Email: moran.shemeshiron@sheba.health.gov.il

Study Locations

• Israel
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Endocrine and Diabetes Unit, Sheba Medical Center
    • Contact: Orit Pinhas-Hamiel, MD; Phone Number: 972-526667385; Email: orit.hamiel@sheba.healtg.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morbid obese adolescents with comorbidity; A weekly intervention of physical education, group psychological support, and nutrition education.	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
No Intervention: Obese children who do not participate in this intervention; This group of adolescents will continue the routine treatment in the clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	The change in weight from the baseline of the study to the end of the study	1 year
Psychological well-being - improvement in coherence	Sense of Coherence Scale - by Antonovsky	3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Improvement in physical fitness	Improvement in physical fitness The 6-minute walking test (6MWT) - an acceptable walking test	3 and 6 months
An increase in motivation for the IDF recruitment process	Number of participant who will eventually be recruited to the army	3 and 6 months
Decrease in Depression	A decrease in the level of depression - Using PHQ9-	3 and 6 months
Increase in social support	Scale of Perceiver Social Support MSPSS by (Ziment, Dahlem, Ziment and Fanley, 1988)	3 and 6 months
Improvement in quality of life	Improvement in quality of life -Improvement in quality of life - (IWQOL-Kids)	3 and 6 months
Improvement in self-efficacy -	Self Efficacy questionnaire by Chen, Gully and Eden 2001	3 and 6 months
Balance test: testing balance	Dynamic balance test - Star Excursion Balance Test	3 and 6 months
Balance test: testing balance time measurement.	Stork Balance Stand Test	3 and 6 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): October 10, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: morbid obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Obesity, Morbid
• Other Study ID Numbers: 0392-23-SMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No