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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Morbid Obesity in Children and Adolescents : Does Inpatient Treatment in a Psychosomatic Unit Increases the Chance for a Long-term Weight Maintenance?

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 Summary:

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. Th
Sponsor: Rabin Medical Center

Current Primary Outcome: Weight [ Time Frame: 1 year from hospitalization ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Weight [ Time Frame: Pre-hospitalization screening, admission, and 4-month follow-up. ]
  Subject's weight will be measured.
• Clinical condition, as measured in an adapted version of the Morgan-Russel scale. [ Time Frame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up. ]
  The clinical features of morbid obesity and symptoms of other eating disorders are assessed using a semi-structured clinical interview.
• Endocrinological and physical condition [ Time Frame: admission, 4-month follow-up, and 1-year follow-up. ]
  Blood Tests: SMA (including fasting glucose, and lipid profile), blood cell count, HBA1c, TSH, FT4, Folic Acid, Fasting Insulin, B12, Forum. Urine Cortisol. In Acanthosis Nigricans, Hyperlipidemia, or high Blood Pressure, an OGTT test will be performed. In abnormal hepatic enzymes, an abdominal ultrasound will be performed. In menstrual abnormalities additional blood tests will be performed:LH, FSH,Andostrindione, Testosterone,17 OHP, DEHAS. Physical Examination and Diagnostic Tests: BIA (Bioelectrical Bioimpedance Analysis),skinfold thickness measurement, Blood Pressure , EKG.
• Depression as measured by the Beck Depression Inventory (BDI). [ Time Frame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up. ]
  The BDI is a valid and reliable measure of depression.
• Psychological features association with eating disorders measured by Eating Disorders Inventory - 2(EDI-2) [ Time Frame: Pre-hospitalization assessment, admission, 4-month follow-up and 1-year follow-up. ]
  The EDI-2 is a valid and reliable measure of psychological features of eating disorders.
• Symptoms of morbid obesity and eating disorders as measured by the Eating Disorders Examination, questionnaire version (EDE-Q). [ Time Frame: Admission, 4-month follow-up, and 1-year follow-up. ]
  The EDE-Q will be administered as a self-report questionnaire. It is a valid and reliable measure of symptoms of eating disorders and obesity.
• Self-efficacy, as measured by the self-efficacy questionnaire. [ Time Frame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up. ]
  Subject's self-efficacy to control behaviors and feelings realted to obesity and management of weight. The self-efficacy questionnaire was written for this study.
• Motivation for treatment, as measured by the Treatment Motivation Scale (TMQ). [ Time Frame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up. ]
  The TMQ is a valid and reliable measure to assess motivation for treatment.
• Life Habits. [ Time Frame: pre-hospitalization screening, and 4-month follow-up. ]
  Life habits will be assessed using a semi-structured interview designed easpecially for the purpose of the current study. The interview includes questions about eating behaviors, family life style, living arrangements, patterns of food consumption and availability etc.
• Structured Clinical Interview for Axis I DSM-IV Disorders (SCID). [ Time Frame: pre-hospitalization screening. ]
  The SCID is a semi-structured interview designed to assess and diagnose the presence of Axis I disorders.
• Clinical Demographic Questionnaire [ Time Frame: pre-hospitalization screening. ]
  This questionnaire assess demographic information as well as information regarding weight history, development of diatery regime, as well as previous treatment and/or hospitalization.
• Parent's Self-efficacy, as measured by the parent's self-efficacy questionnaire. [ Time Frame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up. ]
  Parent's self-efficacy to help his or her child to control behaviors and feelings realted to obesity and management of weight. The parent's self-efficacy questionnaire was written for this study.
• Child's motivation for treatment, from the perspective of the parent. [ Time Frame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up. ]
  The parent's view on the child's motivation for treatment. This variable will be measured using an adapted veriou of the Treatment Motivation Scale (TMQ).
• Parent's depression as measured by the Beck Depression Inventory (BDI). [ Time Frame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up. ]
  The BDI is a valid and reliable measure of depression.
• Parent's Clinical Demographic Questionnaire [ Time Frame: pre-hospitaliza
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Rabin Medical Center
  

  Dates:
  Date Received: November 9, 2010
  Date Started: December 2010
  Date Completion: September 2014
  Last Updated: July 24, 2011
  Last Verified: May 2010