"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
  Purpose

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 Intervention
Obesity
Behavioral: Sibutramine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • % change in BMI z score [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • absolute weight change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • waist circumference change [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023139

Contacts
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

Locations
United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Jorge L Cabrera, MD, PhD    210-916-0607    jorge.luis.cabrera@us.army.mil   
Contact: Jeffrey R Livezey, MD    210-916-0615    jeffrey.livezey@us.army.mil   
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    jorge.luis.cabrera@us.army.mil   
Contact: Jeffrey R Livezey, MD    210-916-0615    jeffrey.livezey@us.army.mil   
Sponsors and Collaborators
Brooke Army Medical Center
Wilford Hall Medical Center
Investigators
Principal Investigator: Jorge L Cabrera, MD, PhD Brooke Army Medical Center
  More Information

No publications provided

Responsible Party: Jorge L. Cabrera, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01023139     History of Changes
Other Study ID Numbers: c.2009.025
Study First Received: December 1, 2009
Last Updated: December 1, 2009
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Adolescent
Obesity
Pharmacotherapy
Sibutramine

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Sibutramine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents

ClinicalTrials.gov processed this record on September 22, 2014