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The Effect of HealthWear on Short-Term Weight Loss

Primary Purpose

Weight Loss, Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
behavioral weight loss
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18-55 years of age. Body mass index (BMI) between 25.0-39.9 kg/m2. Access to a computer, Internet access, and will demonstrate proficiency with using the Internet and Web-based software programs. Potential participants will be asked to provide the type of computer they have, the name of their internet service provider, and will have to demonstrate their ability to search the internet during their screening visit. Exclusion Criteria: Report losing >5% of current body weight in the previous 6 months. Report participating in a research project involving weight loss or physical activity in the previous 6 months. For women, report being pregnant during the previous 6 months, or planning on becoming pregnant over the following 3 months of the intervention. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. In addition, this will also be obtained as part of the signed medical clearance from the individual's personal physician.) Currently being treated for any medical condition that could impact body weight (i.e., diabetes mellitus, cancer, etc.). History of myocardial infarction, or a history of undergoing heart surgery such as bypass or angioplasty. Taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers). Taking medication that could affect metabolism and/or contribute to a change in body weight (e.g., synthroid). Being treated by a therapist for psychological issues or problems, taking pyschotropic medications, or receiving treatment with psychotropic medications within the previous 6 months. No exclusion criteria shall be based on race, ethnicity, or gender.

Sites / Locations

  • University of Pittsburgh

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

fitness
physical activity
dietary intake
mediators

Full Information

First Posted
September 13, 2005
Last Updated
March 29, 2023
Sponsor
University of Pittsburgh
Collaborators
Roche Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT00177593
Brief Title
The Effect of HealthWear on Short-Term Weight Loss
Official Title
The Effect of HealthWear on Short-Term Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
Roche Diagnostics

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to examine the effect of a computer tracking system and energy expenditure device on weight loss in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
behavioral weight loss
Primary Outcome Measure Information:
Title
weight loss
Secondary Outcome Measure Information:
Title
fitness
Title
physical activity
Title
dietary intake
Title
mediators

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-55 years of age. Body mass index (BMI) between 25.0-39.9 kg/m2. Access to a computer, Internet access, and will demonstrate proficiency with using the Internet and Web-based software programs. Potential participants will be asked to provide the type of computer they have, the name of their internet service provider, and will have to demonstrate their ability to search the internet during their screening visit. Exclusion Criteria: Report losing >5% of current body weight in the previous 6 months. Report participating in a research project involving weight loss or physical activity in the previous 6 months. For women, report being pregnant during the previous 6 months, or planning on becoming pregnant over the following 3 months of the intervention. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. In addition, this will also be obtained as part of the signed medical clearance from the individual's personal physician.) Currently being treated for any medical condition that could impact body weight (i.e., diabetes mellitus, cancer, etc.). History of myocardial infarction, or a history of undergoing heart surgery such as bypass or angioplasty. Taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers). Taking medication that could affect metabolism and/or contribute to a change in body weight (e.g., synthroid). Being treated by a therapist for psychological issues or problems, taking pyschotropic medications, or receiving treatment with psychotropic medications within the previous 6 months. No exclusion criteria shall be based on race, ethnicity, or gender.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Jakicic, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States

12. IPD Sharing Statement

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The Effect of HealthWear on Short-Term Weight Loss

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