Morbid ObesityNCT01254266
The Efficacy of an Inpatient Program for Long-term Weight Maintenance in Children and Adolescents With Morbid Obesity
A study testing inpatient hospitalization and follow up, inpatient treatment and follow up and bariatric surgery in people with Morbid Obesity, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- inpatient hospitalization and follow up, inpatient treatment and follow up and bariatric surgery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
silvana Fennig, MD, +97239253761, silvanaf@clalit.org.il
Silvana Fennig, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- inpatient hospitalization and follow up, inpatient treatment and follow up, bariatric surgery, inpatient treatment with follow up
- Keywords
- morbid obesity, adolescents, inpatient treatment
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inpatient hospitalization and follow upBehavioural
An inpatient program and a 1-year weekly follow up that include multi-disciplinary interventions for weight reduction and maintenance.
inpatient treatment and follow upBehavioural
one month inpatient treatment followed by a year-long follow up on the inpatient unit.
bariatric surgeryProcedure or surgery
bariatric surgery.
inpatient treatment with follow upBehavioural
1 month inpatient treatment followed by a year-long follow up on the inpatient unit.
| Study group | Role | What they receive |
|---|---|---|
| conservative treatment | Experimental | conservative weight reduction treatment in an inpatient unit. Receives: Behavioral: inpatient hospitalization and follow up; Behavioral: inpatient treatment and follow up |
| bariatric surgery | Experimental | inpatient program as a pre- and post- operational 'envelope' for bariatric surgeries. Receives: Procedure: bariatric surgery; Behavioral: inpatient treatment with follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
The subject's weight will be measured.
Measured: 1 year from hospitalization
Secondary outcomes (17)
Weight
Subject's weight will be measured.
Measured: Pre-hospitalization screening, admission, and 4-month follow-up.
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.
Measured: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
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.
Measured: admission, 4-month follow-up, and 1-year follow-up.
Depression as measured by the Beck Depression Inventory (BDI).
The BDI is a valid and reliable measure of depression.
Measured: 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)
The EDI-2 is a valid and reliable measure of psychological features of eating disorders.
Measured: 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).
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.
Measured: Admission, 4-month follow-up, and 1-year follow-up.
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.
Measured: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Motivation for treatment, as measured by the Treatment Motivation Scale (TMQ).
The TMQ is a valid and reliable measure to assess motivation for treatment.
Measured: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
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.
Measured: pre-hospitalization screening, and 4-month follow-up.
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.
Measured: pre-hospitalization screening.
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.
Measured: pre-hospitalization screening.
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.
Measured: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
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).
Measured: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Parent's depression as measured by the Beck Depression Inventory (BDI).
The BDI is a valid and reliable measure of depression.
Measured: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
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.
Measured: pre-hospitalization screening.
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.
Measured: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
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.
Measured: pre-hospitalization screening, and 1-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2013 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Silvana Fennig, M.D., Principal investigator, Rabin Medical CanterTamar Tahar, R.N., Study director, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254266
- Sponsor's protocol ID
- 5833
- Status last verified
- May 2010
- First submitted
- 9 Nov 2010
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbid Obesity in Children and Adolescents : Does Inpatient Treatment in a Psychosomatic Unit Increases the Chance for a Long-term Weight Maintenance?
- ClinicalTrials.gov ID
- NCT01254266
- Acronym / sponsor ID
- 5833
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, adolescents, inpatient treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 6 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative treatment | Experimental | Behavioral: inpatient hospitalization and follow up, Behavioral: inpatient treatment and follow upconservative weight reduction treatment in an inpatient unit. |
| bariatric surgery | Experimental | Procedure: bariatric surgery, Behavioral: inpatient treatment with follow upinpatient program as a pre- and post- operational 'envelope' for bariatric surgeries. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inpatient hospitalization and follow upAn inpatient program and a 1-year weekly follow up that include multi-disciplinary interventions for weight reduction and maintenance. | Behavioural | conservative treatment |
| inpatient treatment and follow upone month inpatient treatment followed by a year-long follow up on the inpatient unit. | Behavioural | conservative treatment |
| bariatric surgerybariatric surgery. | Procedure or surgery | bariatric surgery |
| inpatient treatment with follow up1 month inpatient treatment followed by a year-long follow up on the inpatient unit. | Behavioural | bariatric surgery |
Primary outcome
Weight
Time frame: 1 year from hospitalization
The subject's weight will be measured.
17 secondary outcomes
Weight
Time frame: Pre-hospitalization screening, admission, and 4-month follow-up.
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.
Endocrinological and physical condition
Time frame: admission, 4-month follow-up, and 1-year follow-up.
Depression as measured by the Beck Depression Inventory (BDI).
Time frame: 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)
Time frame: 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).
Time frame: Admission, 4-month follow-up, and 1-year follow-up.
Self-efficacy, as measured by the self-efficacy questionnaire.
Time frame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
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.
Life Habits.
Time frame: pre-hospitalization screening, and 4-month follow-up.
Structured Clinical Interview for Axis I DSM-IV Disorders (SCID).
Time frame: pre-hospitalization screening.
Clinical Demographic Questionnaire
Time frame: pre-hospitalization screening.
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.
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.
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.
Parent's Clinical Demographic Questionnaire
Time frame: pre-hospitalization screening.
Child's clinical condition, from the perspective of the parent.
Time frame: pre-hospitalization screening, admission, 4-month follow-up, and 1-year follow-up.
Child's life habits, from the perspective of the parent.
Time frame: pre-hospitalization screening, and 1-year follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvana Fennig, M.D. principal investigator
Rabin Medical Canter
Tamar Tahar, R.N. study director
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inpatient hospitalization and follow up, inpatient treatment and follow up and bariatric surgery in people with Morbid Obesity, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvana Fennig, M.D. (+972-3-9253761, silvanaf@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 1 year from hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.