Clinical trial NCT01023139: "Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
Official title: "Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Adolescent
Obesity
Pharmacotherapy
Sibutramine
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: 59th Medical Wing
First posted: 2009-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: % change in BMI z score
timeFrame: 12 month
Secondary outcomes:
measure: absolute weight change
timeFrame: 12 months
measure: waist circumference change
timeFrame: 12 month
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: Wilford Hall Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Jorge L Cabrera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: