"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
NCT ID: NCT01023139
Last Updated: 2009-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2009-04-30
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
12 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
59th Medical Wing
FED
Brooke Army Medical Center
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Brooke Army Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jorge L Cabrera, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Brooke Army Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brooke Army Medical Center
San Antonio, Texas, United States
Wilford Hall Medical Center
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jorge L Cabrera, MD, PhD
Role: primary
Jeffrey R Livezey, MD
Role: backup
Jorge L Cabrera, MD, PhD
Role: primary
Jeffrey R Livezey, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
c.2009.025
Identifier Type: -
Identifier Source: org_study_id