Protocol #1:Behavioral Therapy + Placebo or SibutramineNCT00212173
Adolescent Weight Management Study
A study testing Sibutramine and Slim Fast in people with Protocol #1:Behavioral Therapy + Placebo or Sibutramine and Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial summary
Protocol #1:The goals of this study was to examine whether increased weight loss in obese adolescent is induced when the weight loss medication sibutramine is added to a family-based, behavioral weight control program. Protocol #2: This study aims to improve the behavioral treatment of obesity during adolescence. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Protocol #1:Behavioral Therapy + Placebo or Sibutramine, Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food
- What is being tested?
- Sibutramine and Slim Fast
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Aug 2007
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Body Mass Index (BMI) between 28-50 kg/m2
Who cannot join
- Severe cardiovascular problems; arrhythmias
- Hypertension, uncontrolled (blood pressure >140/90 mm Hg)
- Diabetes mellitus (Fasting glucose > 126)
- Other serious medical disorders that would complicate dieting such as: Ulcer disease, cancer, thrombophlebitis, liver or kidney disease
- Current use of weight loss medications, amphetamines, steroids, or aspirin; medications affecting body weight
- Mental retardation or genetic syndromes associated with obesity
Show all 18Show fewer
- Currently pregnant or planning a pregnancy or engaging in sexual activity without using contraceptives. All females will have a serum pregnancy test at baseline and all must agree to use contraception if they are sexually active during the study.
- Glaucoma
- History of major depression, bipolar disorder, or psychosis
- History of anorexia or bulimia
- Alcoholism and other substance abuse
- Use of anti-psychotic or anti-depressant medications in the last 6 months
- Highly dysfunctional family system or parental psychopathology
- Weight loss in the preceding 6 months of 5% or more and/or participation in another weight loss program
- Cigarette smoking or recent cessation
- If taking medication for hypertension or hypercholesterolemia condition must be stable for at least 3 months prior to enrollment in the study
- Chronic use of decongestants
- Intolerance of SlimFast
About this study
Official title: Behavioral & Pharmacologic Therapy of Adolescent Obesity
Protocol #1:The goals of this study was to examine whether increased weight loss in obese adolescent is induced when the weight loss medication sibutramine is added to a family-based, behavioral weight control program.
Protocol #2: This study aims to improve the behavioral treatment of obesity during adolescence. A behavioral program using regular foods will be compared to a behavioral program using a structured meal plan (a portion-controlled approach with liquid-meal replacements [nutritional supplements]). This structured approach may be better for the promotion of weight loss compared to a diet of regular foods.
- Conditions
- Protocol #1:Behavioral Therapy + Placebo or Sibutramine, Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food
- Being tested
- Sibutramine, Slim Fast
- Keywords
- Adolescent, Weight Management, Obesity Treatment, Behavioral Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SibutramineDrug
Slim FastDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
BMI
Secondary outcomes (4)
Blood Pressure
Lipids
Glucose
Insulin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Protocol #1:Behavioral Therapy + Placebo or SibutramineStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert I Berkowitz, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212173
- Sponsor's protocol ID
- DK54713 (completed 2007)
- Status last verified
- Apr 2015
- First submitted
- 13 Sep 2005
- Last updated
- 17 Apr 2015
- Results posted
- No
Publications
Berkowitz RI, Wadden TA, Gehrman CA, Bishop-Gilyard CT, Moore RH, Womble LG, Cronquist JL, Trumpikas NL, Levitt Katz LE, Xanthopoulos MS. Meal replacements in the treatment of adolescent obesity: a randomized controlled trial. Obesity (Silver Spring). 2011 Jun;19(6):1193-9. doi: 10.1038/oby.2010.288. Epub 2010 Dec 9.
PubMed 21151016Bishop-Gilyard CT, Berkowitz RI, Wadden TA, Gehrman CA, Cronquist JL, Moore RH. Weight reduction in obese adolescents with and without binge eating. Obesity (Silver Spring). 2011 May;19(5):982-7. doi: 10.1038/oby.2010.249. Epub 2010 Oct 14.
PubMed 20948512
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral & Pharmacologic Therapy of Adolescent Obesity
- ClinicalTrials.gov ID
- NCT00212173
- Acronym / sponsor ID
- DK54713 (completed 2007)
- Conditions
- Protocol #1:Behavioral Therapy + Placebo or Sibutramine, Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food
- Keywords
- Adolescent, Weight Management, Obesity Treatment, Behavioral Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Sep 2005 (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.
Protocol #1:The goals of this study was to examine whether increased weight loss in obese adolescent is induced when the weight loss medication sibutramine is added to a family-based, behavioral weight control program.
Protocol #2: This study aims to improve the behavioral treatment of obesity during adolescence. A behavioral program using regular foods will be compared to a behavioral program using a structured meal plan (a portion-controlled approach with liquid-meal replacements [nutritional supplements]). This structured approach may be better for the promotion of weight loss compared to a diet of regular foods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) between 28-50 kg/m2
Key exclusion criteria (18 listed)
- Severe cardiovascular problems; arrhythmias
- Hypertension, uncontrolled (blood pressure >140/90 mm Hg)
- Diabetes mellitus (Fasting glucose > 126)
- Other serious medical disorders that would complicate dieting such as: Ulcer disease, cancer, thrombophlebitis, liver or kidney disease
- Current use of weight loss medications, amphetamines, steroids, or aspirin; medications affecting body weight
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 |
|---|---|---|
| Sibutramine | Drug | – |
| Slim Fast | Dietary supplement | – |
Primary outcome
Weight
BMI
4 secondary outcomes
Blood Pressure
Lipids
Glucose
Insulin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
- Results publication: PubMed 21151016Berkowitz RI, Wadden TA, Gehrman CA, Bishop-Gilyard CT, Moore RH, Womble LG, Cronquist JL, Trumpikas NL, Levitt Katz LE, Xanthopoulos MS. Meal replacements in the treatment of adolescent obesity: a randomized controlled trial. Obesity (Silver Spring). 2011 Jun;19(6):1193-9. doi: 10.1038/oby.2010.288. Epub 2010 Dec 9.
- Results publication: PubMed 20948512Bishop-Gilyard CT, Berkowitz RI, Wadden TA, Gehrman CA, Cronquist JL, Moore RH. Weight reduction in obese adolescents with and without binge eating. Obesity (Silver Spring). 2011 May;19(5):982-7. doi: 10.1038/oby.2010.249. Epub 2010 Oct 14.
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.
Robert I Berkowitz, MD principal investigator
Children's Hospital of Philadelphia
Questions about this trial
What is this clinical trial studying?
A study testing Sibutramine and Slim Fast in people with Protocol #1:Behavioral Therapy + Placebo or Sibutramine and Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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 1 inclusion and 18 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: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212173, which also lists 2 linked publications.
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 17 Apr 2015.