The Effect of HealthWear on Short-Term Weight Loss

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00177593
• Collaborator: Roche Diagnostics (Industry)
• Enrollment: 75
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 24.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Obesity	Behavioral: behavioral weight loss	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of HealthWear on Short-Term Weight Loss
• Study Start Date: Jun 1, 2005
• Study Completion Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

1. weight loss []

Secondary Outcome Measures

1. fitness []

2. physical activity []

3. dietary intake []

4. mediators []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

9. No exclusion criteria shall be based on race, ethnicity, or gender.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15203

Sponsors and Collaborators

• University of Pittsburgh
• Roche Diagnostics

Investigators

• Principal Investigator: John M Jakicic, Ph.D., University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00177593
• Other Study ID Numbers: 0503021
• First Posted: Sep 15, 2005
• Last Update Posted: Sep 15, 2005
• Last Verified: Sep 1, 2005

• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

No Results Posted as of Sep 15, 2005