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

Obesity Clinical Trial

— AOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01023139
• Other study ID #: c.2009.025
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2009
• Last updated: December 1, 2009
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: December 2009
• Source: Brooke Army Medical Center
• Contact: Jorge L Cabrera, MD, Ph.D
• Phone: 210-916-0607
• Email: jorge.luis.cabrera[@]us.army.mil
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas
United States	Wilford Hall Medical Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Brooke Army Medical Center	Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change in BMI z score		12 month	No
Secondary	absolute weight change		12 months	No
Secondary	waist circumference change		12 month	No