- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00471172
Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
September 12, 2008 updated by: Pfizer
A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity
The aim of the study was to compare 5 methods of delivering a weight loss lifestyle modification program to obese patients on a background of sibutramine.
The methods differed in the type and frequency of counseling utilized to deliver dietary, physical activity and behavioral recommendations for weight loss.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Behavioral: Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)
- Behavioral: Face-to-face counseling by a dietitian (monthly)
- Behavioral: Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)
- Behavioral: Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week)
- Behavioral: Self help
Study Type
Interventional
Enrollment
350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States
- Pfizer Investigational Site
-
-
Florida
-
Clearwater, Florida, United States
- Pfizer Investigational Site
-
Kissimmee, Florida, United States
- Pfizer Investigational Site
-
Pembroke Pines, Florida, United States
- Pfizer Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, United States
- Pfizer Investigational Site
-
Louisville, Kentucky, United States
- Pfizer Investigational Site
-
-
Massachusetts
-
Milford, Massachusetts, United States
- Pfizer Investigational Site
-
-
North Carolina
-
Charlotte, North Carolina, United States
- Pfizer Investigational Site
-
-
Pennsylvania
-
Harleysville, Pennsylvania, United States
- Pfizer Investigational Site
-
-
Rhode Island
-
Warwick, Rhode Island, United States
- Pfizer Investigational Site
-
-
Tennessee
-
Nashville, Tennessee, United States
- Pfizer Investigational Site
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1- Body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and <40 kg/m2.
- 2- Eligibility to be prescribed sibutramine, following the eligibility requirements listed in the US Package Insert
- 3- Willingness and ability to comply with study related procedures
- 4- Access to Internet and email
Exclusion Criteria:
- Uncontrolled blood pressure (defined as ≥140/90 mmHg), diabetes, coronary heart disease, chronic congestive heart failure, stroke, significant metabolic, hepatic or renal disease, current malignancy, gastric bypass surgery or had a weight loss ≥10%, participated in a structured weight loss program, or had taken weight loss agents during the past 6 months. Women were excluded if pregnant or breastfeeding; women of childbearing potential had to use adequate contraception.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Percentage change in body weight at 6 months.
|
Secondary Outcome Measures
Outcome Measure |
---|
Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
May 7, 2007
First Submitted That Met QC Criteria
May 7, 2007
First Posted (Estimate)
May 9, 2007
Study Record Updates
Last Update Posted (Estimate)
September 15, 2008
Last Update Submitted That Met QC Criteria
September 12, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A9001187
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)
-
VA Connecticut Healthcare SystemTerminated
-
The University of Texas Health Science Center,...National Center for Advancing Translational Sciences (NCATS)CompletedBlood Pressure | Telemedicine | Psychosocial Impairment | Stroke PreventionUnited States
-
Memorial Sloan Kettering Cancer CenterNYU Langone Health; National Comprehensive Cancer Network; New York University...Completed
-
Memorial Sloan Kettering Cancer CenterCompletedRectal CancerUnited States
-
Memorial Sloan Kettering Cancer CenterTufts Medical Center; Lahey ClinicCompleted
-
National Cancer Institute (NCI)RecruitingDown Syndrome | B Acute Lymphoblastic Leukemia | B Lymphoblastic LymphomaUnited States, Canada, Puerto Rico, Australia, New Zealand