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

24. juli 2011 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Israel
      • Petah Tikva, Israel
        • Rekruttering
        • Rabin Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Silvana Fennig, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

    -

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: conservative treatment
conservative weight reduction treatment in an inpatient unit.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: inpatient treatment and follow up
one month inpatient treatment followed by a year-long follow up on the inpatient unit.
Eksperimentel: bariatric surgery
inpatient program as a pre- and post- operational 'envelope' for bariatric surgeries.
Procedure: bariatric surgery
bariatric surgery.
Adfærdsmæssigt: inpatient treatment with follow up
1 month inpatient treatment followed by a year-long follow up on the inpatient unit.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight
Tidsramme: 1 year from hospitalization
The subject's weight will be measured.
1 year from hospitalization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rabin Medical Center

Efterforskere

  • Ledende efterforsker: Silvana Fennig, M.D., Rabin Medical Canter
  • Studieleder: Tamar Tahar, R.N., Rabin Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2010

Primær færdiggørelse (Forventet)

1. juni 2013

Studieafslutning (Forventet)

1. september 2014

Datoer for studieregistrering

Først indsendt

9. november 2010

Først indsendt, der opfyldte QC-kriterier

2. december 2010

Først opslået (Skøn)

6. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2011

Sidst verificeret

1. maj 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5833

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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