The Effect of HealthWear on Short-Term Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177593
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Roche Diagnostics
Information provided by:
University of Pittsburgh

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 Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
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 : June 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. weight loss

Secondary Outcome Measures :
  1. fitness
  2. physical activity
  3. dietary intake
  4. mediators

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177593

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
University of Pittsburgh
Roche Diagnostics
Principal Investigator: John M Jakicic, Ph.D. University of Pittsburgh Identifier: NCT00177593     History of Changes
Other Study ID Numbers: 0503021
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 15, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes