Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

24 luglio 2011 aggiornato da: Rabin Medical Center

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

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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Israele
      • Petah Tikva, Israele
        • Reclutamento
        • Rabin Medical Center
        • Contatto:
        • Investigatore principale:
          • Silvana Fennig, M.D.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 10 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

    -

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: conservative treatment
conservative weight reduction treatment in an inpatient unit.
Comportamentale: 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.
Comportamentale: inpatient treatment and follow up
one month inpatient treatment followed by a year-long follow up on the inpatient unit.
Sperimentale: bariatric surgery
inpatient program as a pre- and post- operational 'envelope' for bariatric surgeries.
Procedura: bariatric surgery
bariatric surgery.
Comportamentale: inpatient treatment with follow up
1 month inpatient treatment followed by a year-long follow up on the inpatient unit.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Weight
Lasso di tempo: 1 year from hospitalization
The subject's weight will be measured.
1 year from hospitalization

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Weight
Lasso di tempo: Pre-hospitalization screening, admission, and 4-month follow-up.
Subject's weight will be measured.
Pre-hospitalization screening, admission, and 4-month follow-up.
Clinical condition, as measured in an adapted version of the Morgan-Russel scale.
Lasso di tempo: 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.
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Endocrinological and physical condition
Lasso di tempo: 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.
admission, 4-month follow-up, and 1-year follow-up.
Depression as measured by the Beck Depression Inventory (BDI).
Lasso di tempo: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
The BDI is a valid and reliable measure of depression.
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)
Lasso di tempo: 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.
Pre-hospitalization assessment, admission, 4-month follow-up and 1-year follow-up.
Symptoms of morbid obesity and eating disorders as measured by the Eating Disorders Examination, questionnaire version (EDE-Q).
Lasso di tempo: 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.
Admission, 4-month follow-up, and 1-year follow-up.
Self-efficacy, as measured by the self-efficacy questionnaire.
Lasso di tempo: 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.
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Motivation for treatment, as measured by the Treatment Motivation Scale (TMQ).
Lasso di tempo: 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.
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Life Habits.
Lasso di tempo: 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.
pre-hospitalization screening, and 4-month follow-up.
Structured Clinical Interview for Axis I DSM-IV Disorders (SCID).
Lasso di tempo: pre-hospitalization screening.
The SCID is a semi-structured interview designed to assess and diagnose the presence of Axis I disorders.
pre-hospitalization screening.
Clinical Demographic Questionnaire
Lasso di tempo: 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.
pre-hospitalization screening.
Parent's Self-efficacy, as measured by the parent's self-efficacy questionnaire.
Lasso di tempo: 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.
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Child's motivation for treatment, from the perspective of the parent.
Lasso di tempo: 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).
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Parent's depression as measured by the Beck Depression Inventory (BDI).
Lasso di tempo: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
The BDI is a valid and reliable measure of depression.
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Parent's Clinical Demographic Questionnaire
Lasso di tempo: pre-hospitalization screening.
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.
pre-hospitalization screening.
Child's clinical condition, from the perspective of the parent.
Lasso di tempo: 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 based on and adaptation of the well-establised Morgan-Russel Scale.
pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Child's life habits, from the perspective of the parent.
Lasso di tempo: pre-hospitalization screening, and 1-year 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.
pre-hospitalization screening, and 1-year follow-up.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Rabin Medical Center

Investigatori

  • Investigatore principale: Silvana Fennig, M.D., Rabin Medical Canter
  • Direttore dello studio: Tamar Tahar, R.N., Rabin Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2010

Completamento primario (Anticipato)

1 giugno 2013

Completamento dello studio (Anticipato)

1 settembre 2014

Date di iscrizione allo studio

Primo inviato

9 novembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

2 dicembre 2010

Primo Inserito (Stima)

6 dicembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 luglio 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 luglio 2011

Ultimo verificato

1 maggio 2010

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 5833

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su inpatient hospitalization and follow up

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Oman

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi