The Effect of HealthWear on Short-Term Weight Loss

NCT ID: NCT00177593

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2005-09-30

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.

Conditions

Weight Loss; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

behavioral weight loss

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 18-55 years of age.

2. Body mass index (BMI) between 25.0-39.9 kg/m2.

3. 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

1. Report losing >5% of current body weight in the previous 6 months.

2. Report participating in a research project involving weight loss or physical activity in the previous 6 months.

3. 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.)

4. Currently being treated for any medical condition that could impact body weight (i.e., diabetes mellitus, cancer, etc.).

5. History of myocardial infarction, or a history of undergoing heart surgery such as bypass or angioplasty.

6. Taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers).

7. Taking medication that could affect metabolism and/or contribute to a change in body weight (e.g., synthroid).

8. Being treated by a therapist for psychological issues or problems, taking pyschotropic medications, or receiving treatment with psychotropic medications within the previous 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John M Jakicic, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

0503021

Identifier Type: -

Identifier Source: org_study_id