"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

NCT06102538 | Unknown

• 1 other identifier: 0392-23-SMC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 \[The medical accompaniment to the program will take place on the basis of the patients' mother clinics and the medical follow-up of them will be done separately\].

Conditions

Morbid Obesity

Keywords

morbid obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Improving eating habits

  3 and 6 months

• Improvement in physical fitness

  3 and 6 months

• An increase in motivation for the IDF recruitment process

  3 and 6 months

• Decrease in Depression

  3 and 6 months

• Increase in social support

  3 and 6 months

Study Arms (2)

Morbid obese adolescents with comorbidity

ACTIVE COMPARATOR

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

Obese children who do not participate in this intervention

NO INTERVENTION

This group of adolescents will continue the routine treatment in the clinic

Interventions

# The importance of service in the IDF # Physical activity # Healthy nutrition # Psychological support BEHAVIORAL

\# 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

Morbid obese adolescents with comorbidity

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Endocrine and Diabetes Unit, Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Orit Hamiel, Prof

CONTACT

+972526667385; orit.hamiel@sheba.health.gov.il

Moran Shemesh- Iron, MA

CONTACT

+972542475008; moran.shemeshiron@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pediatric endocrinology and diabetes unit

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 26, 2023
• Study Start: October 9, 2023
• Primary Completion: October 10, 2024
• Study Completion: December 30, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

IL (1)