Back to results"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention" (AOS)
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sibutramine
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Adolescent, Obesity, Pharmacotherapy, Sibutramine
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- Drugs and/or supplements administered for the first time or withdrawn during the past 6 months which have a significant impact on body weight or digestion (see Appendix D)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
Sites / Locations
- Brooke Army Medical CenterRecruiting
- Wilford Hall Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of care (SOC)
Continuing Behavioral Therapy (CoBT)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
% change in BMI z score
Secondary Outcome Measures
absolute weight change
waist circumference change
Full Information
NCT ID
NCT01023139
First Posted
December 1, 2009
Last Updated
December 1, 2009
Sponsor
Brooke Army Medical Center
Collaborators
59th Medical Wing
1. Study Identification
Unique Protocol Identification Number
NCT01023139
Brief Title
"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
Acronym
AOS
Official Title
"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Brooke Army Medical Center
Collaborators
59th Medical Wing
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Adolescent, Obesity, Pharmacotherapy, Sibutramine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care (SOC)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Continuing Behavioral Therapy (CoBT)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Sibutramine
Intervention Description
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
Primary Outcome Measure Information:
Title
% change in BMI z score
Time Frame
12 month
Secondary Outcome Measure Information:
Title
absolute weight change
Time Frame
12 months
Title
waist circumference change
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge L Cabrera, MD, Ph.D
Phone
210-916-0607
Email
jorge.luis.cabrera@us.army.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey R Livezey, MD
Phone
210-916-0615
Email
jeffrey.livezey@us.army.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge L Cabrera, MD, PhD
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge L Cabrera, MD, PhD
Phone
210-916-0607
Email
jorge.luis.cabrera@us.army.mil
First Name & Middle Initial & Last Name & Degree
Jeffrey R Livezey, MD
Phone
210-916-0615
Email
jeffrey.livezey@us.army.mil
First Name & Middle Initial & Last Name & Degree
Jorge L Cabrera, MD, PhD
Facility Name
Wilford Hall Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge L Cabrera, MD, PhD
Phone
210-916-0607
Email
jorge.luis.cabrera@us.army.mil
First Name & Middle Initial & Last Name & Degree
Jeffrey R Livezey, MD
Phone
210-916-0615
Email
jeffrey.livezey@us.army.mil
12. IPD Sharing Statement
Learn more about this trial
"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"
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