The Effect of HealthWear on Short-Term Weight Loss

Obesity Clinical Trial

Official title:

The Effect of HealthWear on Short-Term Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177593
• Other study ID #: 0503021
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2005
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

Behavioral:
• behavioral weight loss

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Roche Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss
Secondary	fitness
Secondary	physical activity
Secondary	dietary intake
Secondary	mediators