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"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention" (AOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01023139
Recruitment Status : Unknown
Verified December 2009 by Brooke Army Medical Center.
Recruitment status was:  Recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Wilford Hall Medical Center
Information provided by:
Brooke Army Medical Center

Brief Summary:

There are few studies that look at sustained weight loss in the adolescent population. This study uses a multidisciplinary approach along with pharmacotherapy (use of Meridia)to motivate and establish behavior changes in adolescents (12-18yo) during the first phase of the study.

The second phase will have those who have lost at least 5% BMI to be randomized into one of two groups. This first group will have no intervention and will be followed at 3 and 6 months to assess for weight loss maintenance. The second group will continue on with monthly behavior modifications and also be evaluated at 3 and 6 months.

The hypothesis proposed is that, 1)there will be sustained weight loss at the end of one year in both arms as compared to baseline BMI, 2) and the arm with the behavioral therapy intervention will be more successful than no intervention at weight loss maintenance.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Sibutramine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
Study Start Date : April 2009
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
No Intervention: Standard of care (SOC)
No intervention following phase 1 of the study is done during this 2nd phase. Participants will have their height and weights examined at 3 month and 6 month following end of phase 1. During these two visits, they will receive counseling from the physician regarding food choices and exercise maintenance.
Experimental: Continuing Behavioral Therapy (CoBT)
This arm follows the end of the phase 1 which incorporates behavioral therapy, nutrition counseling and pharmacotherapy with Sibutramine while medically supervised. Participants randomized to this arm no longer receive medication and will receive behavioral therapy once a month and then evaluated at 3 months and six months for weight loss maintenance.
Behavioral: Sibutramine
During phase 1, sibutramine is given to all participants, 10mg po q day. If they do not meet a change in BMI of at least 2.5%,then the dosage may be increased to 15mg po q day. The main intervention in the study during phase 1 and 2is the behavioral modification

Primary Outcome Measures :
  1. % change in BMI z score [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. absolute weight change [ Time Frame: 12 months ]
  2. waist circumference change [ Time Frame: 12 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age: > or = 12 and < or = 18 years old at the time of screening

    • BMI that is at least more than the U.S. weighted mean of the 95th percentile based on age and sex
    • Willing to lose weight to meet and continue study medication for the 12 month treatment period even if he/she meets personal weight loss goal.
    • Willing to not start any new weight loss products
    • Males or non-pregnant females (pregnancy determined by self-report)
    • Females of childbearing potential if practicing acceptable method of contraception

Exclusion Criteria:

  • Weight loss ≥ 10 pounds in previous 3 months
  • Active gastrointestinal disorders (except GERD) such as peptic ulcer disease, irritable bowel disease, and gallbladder condition (in last 3 months); inflammable bowel disease (Crohn's ulcerative colitis, celiac sprue)
  • At least 2 out of 3 blood pressure readings either systolic or diastolic ≥ 95%ile for height and age or pulse ≥95 beats per minute at initial visit.
  • Drug treated diabetes mellitus or drug treated hypertension
  • Drugs and/or supplements administered for the first time or withdrawn during the past 6 months which have a significant impact on body weight or digestion (see Appendix D)
  • Inability or unwillingness to comply with protocol requirements, i.e. considered to be unfit for study participation, or unable to swallow pills.
  • Unwilling to avoid consumption of alcoholic beverages
  • Smoking or has started a smoking cessation program within the past six months
  • Previous treatment with prescription sibutramine (Meridia®)
  • History of recurrent nephrolithiasis
  • Major psychiatric or eating disorders (i.e., major depressive disorder, bipolar disorder, anorexia nervosa, bulimia or laxative abuse)
  • Kidney, liver, or thyroid disorder
  • Drugs that are contraindicated with concomitant use of sibutramine (Meridia®) within last 4 weeks (See Appendix E)
  • Cardiovascular disease (including arrhythmias, heart failure or congenital heart defect
  • History of bleeding problems, hemophilia
  • History of migraine headaches; seizures; a stroke or mini-stroke
  • History of Pulmonary hypertension
  • Osteopenia or osteoporosis
  • Self-report of current recreational drug use or overused prescription medications
  • History of glaucoma
  • Females who self-report pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01023139

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Contact: Jorge L Cabrera, MD, Ph.D 210-916-0607
Contact: Jeffrey R Livezey, MD 210-916-0615

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United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Jorge L Cabrera, MD, PhD    210-916-0607   
Contact: Jeffrey R Livezey, MD    210-916-0615   
Principal Investigator: Jorge L Cabrera, MD, PhD         
Wilford Hall Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Jorge L Cabrera, MD, PhD    210-916-0607   
Contact: Jeffrey R Livezey, MD    210-916-0615   
Sponsors and Collaborators
Brooke Army Medical Center
Wilford Hall Medical Center
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Principal Investigator: Jorge L Cabrera, MD, PhD Brooke Army Medical Center

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Responsible Party: Jorge L. Cabrera, Brooke Army Medical Center Identifier: NCT01023139    
Other Study ID Numbers: c.2009.025
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009
Keywords provided by Brooke Army Medical Center:
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents