Study of Five Different Methods Of Delivering A Lifestyle... | NCT00471172

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

NCT00471172

Sponsor

Pfizer

Status

Completed

Last Update Posted

Sep 15, 2008Estimated

Enrollment

350

Phase

Not Applicable

Conditions

Obesity

Interventions

Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)
Face-to-face counseling by a dietitian (monthly)
Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)
Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week)
Self help

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

May 2005Actual

First Submitted Date

May 7, 2007

First Submission Date that Met QC Criteria

May 7, 2007

First Posted Date

May 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2008

Last Update Posted Date

Sep 15, 2008Estimated

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage change in body weight at 6 months.

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Los Angeles	California		United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms