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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Brooke Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Wilford Hall Medical Center
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01023139
First received: December 1, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 1, 2009
December 1, 2009
April 2009
November 2010   (final data collection date for primary outcome measure)
% change in BMI z score [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • absolute weight change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • waist circumference change [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
Yes
Contact: Jorge L Cabrera, MD, Ph.D 210-916-0607 jorge.luis.cabrera@us.army.mil
Contact: Jeffrey R Livezey, MD 210-916-0615 jeffrey.livezey@us.army.mil
United States
 
NCT01023139
c.2009.025
No
Jorge L. Cabrera, Brooke Army Medical Center
Brooke Army Medical Center
Wilford Hall Medical Center
Principal Investigator: Jorge L Cabrera, MD, PhD Brooke Army Medical Center
Brooke Army Medical Center
December 2009

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