Clinical trial NCT01254266: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Keywords: morbid obesity
adolescents
inpatient treatment
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

   -

Primary outcomes:
measure: Weight
timeFrame: 1 year from hospitalization
Secondary outcomes:
measure: Weight
timeFrame: Pre-hospitalization screening, admission, and 4-month follow-up.
measure: Clinical condition, as measured in an adapted version of the Morgan-Russel scale.
timeFrame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
measure: Endocrinological and physical condition
timeFrame: admission, 4-month follow-up, and 1-year follow-up.
measure: Depression as measured by the Beck Depression Inventory (BDI).
timeFrame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
measure: Psychological features association with eating disorders measured by Eating Disorders Inventory - 2(EDI-2)
timeFrame: Pre-hospitalization assessment, admission, 4-month follow-up and 1-year follow-up.
measure: Symptoms of morbid obesity and eating disorders as measured by the Eating Disorders Examination, questionnaire version (EDE-Q).
timeFrame: Admission, 4-month follow-up, and 1-year follow-up.
measure: Self-efficacy, as measured by the self-efficacy questionnaire.
timeFrame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
measure: Motivation for treatment, as measured by the Treatment Motivation Scale (TMQ).
timeFrame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
measure: Life Habits.
timeFrame: pre-hospitalization screening, and 4-month follow-up.
measure: Structured Clinical Interview for Axis I DSM-IV Disorders (SCID).
timeFrame: pre-hospitalization screening.
measure: Clinical Demographic Questionnaire
timeFrame: pre-hospitalization screening.
measure: Parent's Self-efficacy, as measured by the parent's self-efficacy questionnaire.
timeFrame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
measure: Child's motivation for treatment, from the perspective of the parent.
timeFrame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
measure: Parent's depression as measured by the Beck Depression Inventory (BDI).
timeFrame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
measure: Parent's Clinical Demographic Questionnaire
timeFrame: pre-hospitalization screening.
measure: Child's clinical condition, from the perspective of the parent.
timeFrame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
measure: Child's life habits, from the perspective of the parent.
timeFrame: pre-hospitalization screening, and 1-year follow-up.
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Canter
name: Silvana Fennig, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin Medical Center
name: Tamar Tahar, R.N.
role: STUDY_DIRECTOR
References: