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

NCT01254266 | Unknown

• 1 other identifier: 5833
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

morbid obesity; adolescents; inpatient treatment

Outcome Measures

Primary Outcomes (1)

• Weight

  The subject's weight will be measured.

  1 year from hospitalization

Secondary Outcomes (17)

• Weight

  Pre-hospitalization screening, admission, and 4-month follow-up.

• Clinical condition, as measured in an adapted version of the Morgan-Russel scale.

  pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.

• Endocrinological and physical condition

  admission, 4-month follow-up, and 1-year follow-up.

• Depression as measured by the Beck Depression Inventory (BDI).

  pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.

• Psychological features association with eating disorders measured by Eating Disorders Inventory - 2(EDI-2)

  Pre-hospitalization assessment, admission, 4-month follow-up and 1-year follow-up.

Study Arms (2)

conservative treatment

EXPERIMENTAL

conservative weight reduction treatment in an inpatient unit.

Behavioral: inpatient hospitalization and follow up; Behavioral: inpatient treatment and follow up

bariatric surgery

EXPERIMENTAL

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

Procedure: bariatric surgery; Behavioral: inpatient treatment with follow up

Interventions

inpatient hospitalization and follow up BEHAVIORAL

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

conservative treatment

inpatient treatment and follow up BEHAVIORAL

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

conservative treatment

bariatric surgery PROCEDURE

bariatric surgery.

bariatric surgery

inpatient treatment with follow up BEHAVIORAL

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

bariatric surgery

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Previous failures in obtaining weight reduction in the framework of intensive, outpatient programs.
• Voluntary participation by the child and his or her family and high motivation for change as assessed in a pre-hospitalization assessment.

You may not qualify if:

• Failure of parents in applying changes required by the program (e.g., missing parent guidance appointments).
• Lack of cooperation with the program (e.g., non-compliance with dietary regime, failure in maintaining food diaries).
• Failure to obtain weight reduction in two consecutive weeks, without a clear physical or medical cause.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Length of Stay; Hospitalization; Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Bariatrics; Obesity Management; Surgical Procedures, Operative

Study Officials

• Silvana Fennig, M.D.

  Rabin Medical Canter

  PRINCIPAL INVESTIGATOR

• Tamar Tahar, R.N.

  Rabin Medical Center

  STUDY DIRECTOR

Central Study Contacts

Silvana Fennig, M.D.

CONTACT

+972-3-9253761; silvanaf@clalit.org.il

Tamar Tahar, R.N.

CONTACT

+972-3-9253761; drorac@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: December 6, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2014
• Last Updated: July 26, 2011

Record last verified: 2010-05

Locations

IL (1)