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

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
inpatient hospitalization and follow up
inpatient treatment and follow up
bariatric surgery
inpatient treatment with follow up
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring morbid obesity, adolescents, inpatient treatment

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

    -

Sites / Locations

  • Rabin Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

conservative treatment

bariatric surgery

Arm Description

conservative weight reduction treatment in an inpatient unit.

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

Outcomes

Primary Outcome Measures

Weight
The subject's weight will be measured.

Secondary Outcome Measures

Weight
Subject's weight will be measured.
Clinical condition, as measured in an adapted version of the Morgan-Russel scale.
The clinical features of morbid obesity and symptoms of other eating disorders are assessed using a semi-structured clinical interview.
Endocrinological and physical condition
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).
The BDI is a valid and reliable measure of depression.
Psychological features association with eating disorders measured by Eating Disorders Inventory - 2(EDI-2)
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).
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.
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).
The TMQ is a valid and reliable measure to assess motivation for treatment.
Life Habits.
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).
The SCID is a semi-structured interview designed to assess and diagnose the presence of Axis I disorders.
Clinical Demographic Questionnaire
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.
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.
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).
The BDI is a valid and reliable measure of depression.
Parent's Clinical Demographic Questionnaire
This questionnaire assess demographic information as well as information regarding child's weight history, development of diatery regime, as well as previous treatment and/or hospitalization.
Child's clinical condition, from the perspective of the parent.
The clinical features of morbid obesity and symptoms of other eating disorders are assessed using a semi-structured clinical interview based on and adaptation of the well-establised Morgan-Russel Scale.
Child's life habits, from the perspective of the parent.
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.

Full Information

First Posted
November 9, 2010
Last Updated
July 24, 2011
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01254266
Brief Title
The Efficacy of an Inpatient Program for Long-term Weight Maintenance in Children and Adolescents With Morbid Obesity
Official Title
Morbid Obesity in Children and Adolescents : Does Inpatient Treatment in a Psychosomatic Unit Increases the Chance for a Long-term Weight Maintenance?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
morbid obesity, adolescents, inpatient treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conservative treatment
Arm Type
Experimental
Arm Description
conservative weight reduction treatment in an inpatient unit.
Arm Title
bariatric surgery
Arm Type
Experimental
Arm Description
inpatient program as a pre- and post- operational 'envelope' for bariatric surgeries.
Intervention Type
Behavioral
Intervention Name(s)
inpatient hospitalization and follow up
Intervention Description
An inpatient program and a 1-year weekly follow up that include multi-disciplinary interventions for weight reduction and maintenance.
Intervention Type
Behavioral
Intervention Name(s)
inpatient treatment and follow up
Intervention Description
one month inpatient treatment followed by a year-long follow up on the inpatient unit.
Intervention Type
Procedure
Intervention Name(s)
bariatric surgery
Intervention Description
bariatric surgery.
Intervention Type
Behavioral
Intervention Name(s)
inpatient treatment with follow up
Intervention Description
1 month inpatient treatment followed by a year-long follow up on the inpatient unit.
Primary Outcome Measure Information:
Title
Weight
Description
The subject's weight will be measured.
Time Frame
1 year from hospitalization
Secondary Outcome Measure Information:
Title
Weight
Description
Subject's weight will be measured.
Time Frame
Pre-hospitalization screening, admission, and 4-month follow-up.
Title
Clinical condition, as measured in an adapted version of the Morgan-Russel scale.
Description
The clinical features of morbid obesity and symptoms of other eating disorders are assessed using a semi-structured clinical interview.
Time Frame
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Title
Endocrinological and physical condition
Description
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.
Time Frame
admission, 4-month follow-up, and 1-year follow-up.
Title
Depression as measured by the Beck Depression Inventory (BDI).
Description
The BDI is a valid and reliable measure of depression.
Time Frame
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Title
Psychological features association with eating disorders measured by Eating Disorders Inventory - 2(EDI-2)
Description
The EDI-2 is a valid and reliable measure of psychological features of eating disorders.
Time Frame
Pre-hospitalization assessment, admission, 4-month follow-up and 1-year follow-up.
Title
Symptoms of morbid obesity and eating disorders as measured by the Eating Disorders Examination, questionnaire version (EDE-Q).
Description
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.
Time Frame
Admission, 4-month follow-up, and 1-year follow-up.
Title
Self-efficacy, as measured by the self-efficacy questionnaire.
Description
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.
Time Frame
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Title
Motivation for treatment, as measured by the Treatment Motivation Scale (TMQ).
Description
The TMQ is a valid and reliable measure to assess motivation for treatment.
Time Frame
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Title
Life Habits.
Description
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.
Time Frame
pre-hospitalization screening, and 4-month follow-up.
Title
Structured Clinical Interview for Axis I DSM-IV Disorders (SCID).
Description
The SCID is a semi-structured interview designed to assess and diagnose the presence of Axis I disorders.
Time Frame
pre-hospitalization screening.
Title
Clinical Demographic Questionnaire
Description
This questionnaire assess demographic information as well as information regarding weight history, development of diatery regime, as well as previous treatment and/or hospitalization.
Time Frame
pre-hospitalization screening.
Title
Parent's Self-efficacy, as measured by the parent's self-efficacy questionnaire.
Description
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.
Time Frame
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Title
Child's motivation for treatment, from the perspective of the parent.
Description
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).
Time Frame
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Title
Parent's depression as measured by the Beck Depression Inventory (BDI).
Description
The BDI is a valid and reliable measure of depression.
Time Frame
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Title
Parent's Clinical Demographic Questionnaire
Description
This questionnaire assess demographic information as well as information regarding child's weight history, development of diatery regime, as well as previous treatment and/or hospitalization.
Time Frame
pre-hospitalization screening.
Title
Child's clinical condition, from the perspective of the parent.
Description
The clinical features of morbid obesity and symptoms of other eating disorders are assessed using a semi-structured clinical interview based on and adaptation of the well-establised Morgan-Russel Scale.
Time Frame
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Title
Child's life habits, from the perspective of the parent.
Description
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.
Time Frame
pre-hospitalization screening, and 1-year follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvana Fennig, M.D.
Phone
+972-3-9253761
Email
silvanaf@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Tamar Tahar, R.N.
Phone
+972-3-9253761
Email
drorac@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvana Fennig, M.D.
Organizational Affiliation
Rabin Medical Canter
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamar Tahar, R.N.
Organizational Affiliation
Rabin Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
silvana Fennig, MD
Phone
+97239253761
Email
silvanaf@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Silvana Fennig, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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