The Efficacy of an Inpatient Program for Long-term Weight Maintenance in Children and Adolescents With Morbid Obesity

NCT ID: NCT01254266

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-09-30

Brief Summary

The major problem in the treatment of morbidly obese children is the long term maintenance of the reduced weight. Maintenance-focused interventions have not been studied enough in adolescents with morbid obesity, neither in regard to conservative methods of weight reduction, nor in regard to bariatric surgeries.

This study will investigate the effectiveness of an integrative, multi-disciplinary inpatient program for promoting long-term weight maintenance in children with morbid obesity. The program will be studied in two perspectives: as a conservative treatment, as well as an 'envelope' for bariatric surgeries including a pre-operational preparation phase and a post-operational follow-up.

The investigators hypothesize that program participants will maintain weight significantly better than the proportion known in the literature.

Detailed Description

Background: The major problem in the treatment of morbidly obese children and adolescents is not weight reduction itself, but the long term maintenance of the reduced weight. Treatment of morbid obesity has a dual goal: Immediate relief for the obesity-related physical symptoms (by moderate weight reduction), and prevention of relapse by encouraging weight maintenance. Without maintenance-focused interventions, morbidly obese children are prone for repeated weight gains that can induce further complications and undermine therapeutic efforts. Maintenance-focused interventions have not been studied enough in adolescents with morbid obesity. An alternative solution for the conservative approach described above is based on bariatric surgeries. These are currently limited in adolescents due to insufficient evidence regarding pre- and post-operational interventions for long term weight maintenance.

Goals: The study is designed to investigate the effect of an integrative, multi-disciplinary program for children and adolescents with morbid obesity. The program includes interventions for moderate weight reduction and for long term weight maintenance. The program is based on a year-long treatment continuum. The different phases of this continuum include a short hospitalization, intensive day treatment program, and weekly follow up. The program is also based on intensive work with parents, with emphasis on familial change of life habits. The program will be studied in two perspectives: as a conservative treatment, as well as an 'envelope' for bariatric surgeries including a pre-operational preparation phase and a post-operational follow-up.

Hypothesis: The proportion of program participants who will decrease their weight and maintain it for at least one year will be significantly higher than the proportion known in the literature. This finding is expected among participants in the 'conservative' program as well as among participants who will undergo bariatric surgeries.

Method: the study will take place in a child and adolescent psychiatric unit located in a general children hospital, in cooperation with pediatric and endocrinology units. Participants will undergo short hospitalization focused on acute relief of obesity related complications and as a pre-operational preparation for those participants who are designated for surgery. All participants, whether designed for operation or not, will continue participation in a year long day program focused on weight maintenance and acquisition of healthy life habits. Study design will include 4 assessments of psychical and psychological measures: pre-hospitalization screening, admission, 4-month follow up, 1-year follow up. At those assessment points, both children and parents will be assessed.

Conditions

Morbid Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conservative treatment

conservative weight reduction treatment in an inpatient unit.

Group Type: EXPERIMENTAL

inpatient hospitalization and follow up

Intervention Type: BEHAVIORAL

An inpatient program and a 1-year weekly follow up that include multi-disciplinary interventions for weight reduction and maintenance.

inpatient treatment and follow up

Intervention Type: BEHAVIORAL

one month inpatient treatment followed by a year-long follow up on the inpatient unit.

bariatric surgery

inpatient program as a pre- and post- operational 'envelope' for bariatric surgeries.

Group Type: EXPERIMENTAL

bariatric surgery

Intervention Type: PROCEDURE

bariatric surgery.

inpatient treatment with follow up

Intervention Type: BEHAVIORAL

1 month inpatient treatment followed by a year-long follow up on the inpatient unit.

Interventions

inpatient hospitalization and follow up

An inpatient program and a 1-year weekly follow up that include multi-disciplinary interventions for weight reduction and maintenance.

Intervention Type: BEHAVIORAL

inpatient treatment and follow up

one month inpatient treatment followed by a year-long follow up on the inpatient unit.

Intervention Type: BEHAVIORAL

bariatric surgery

bariatric surgery.

Intervention Type: PROCEDURE

inpatient treatment with follow up

1 month inpatient treatment followed by a year-long follow up on the inpatient unit.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. BMI > 40, with a physical complication known to improve by weight reduction or BMI > 95% for age and weight with a serious obesity-related physical complication that without intervention would require acute invasive procedure.

2. Previous failures in obtaining weight reduction in the framework of intensive, outpatient programs.

3. Voluntary participation by the child and his or her family and high motivation for change as assessed in a pre-hospitalization assessment.

Exclusion Criteria

1. Failure of parents in applying changes required by the program (e.g., missing parent guidance appointments).

2. Lack of cooperation with the program (e.g., non-compliance with dietary regime, failure in maintaining food diaries).

3. Failure to obtain weight reduction in two consecutive weeks, without a clear physical or medical cause.

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• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rabin Medical Center

Principal Investigators

Silvana Fennig, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Canter

Tamar Tahar, R.N.

Role: STUDY_DIRECTOR

Rabin Medical Center

Locations

Rabin Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Silvana Fennig, M.D.

Role: CONTACT

silvanaf@clalit.org.il

+972-3-9253761

Tamar Tahar, R.N.

Role: CONTACT

drorac@clalit.org.il

+972-3-9253761

Facility Contacts

silvana Fennig, MD

Role: primary

silvanaf@clalit.org.il

+97239253761

Other Identifiers

5833

Identifier Type: -

Identifier Source: org_study_id