Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss - Tabular View

Tracking Information

First Received Date ^ICMJE

May 7, 2007

Last Updated Date

September 12, 2008

Start Date ^ICMJE

August 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Percentage change in body weight at 6 months.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00471172 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss

Official Title ^ICMJE

A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

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 Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

350

Completion Date

May 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

25 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00471172

Responsible Party

Study ID Numbers ^ICMJE

A9001187

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP