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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

Tracking Information
First Submitted Date  ICMJE December 1, 2009
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date December 2, 2009
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
% change in BMI z score [ Time Frame: 12 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
  • absolute weight change [ Time Frame: 12 months ]
  • waist circumference change [ Time Frame: 12 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE "Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
Official Title  ICMJE "Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Sibutramine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2011
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01023139
Other Study ID Numbers  ICMJE c.2009.025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jorge L. Cabrera, Brooke Army Medical Center
Study Sponsor  ICMJE Brooke Army Medical Center
Collaborators  ICMJE Wilford Hall Medical Center
Investigators  ICMJE
Principal Investigator: Jorge L Cabrera, MD, PhD Brooke Army Medical Center
PRS Account Brooke Army Medical Center
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP