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The Effect of HealthWear on Short-Term Weight Loss
This study has been completed.
Sponsors and Collaborators: University of Pittsburgh
Hoffmann-La Roche
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177593
  Purpose

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 Intervention Phase
Weight Loss
Obesity
Behavioral: behavioral weight loss
Phase I
Phase II

MedlinePlus related topics: Obesity Weight Control
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Official Title: The Effect of HealthWear on Short-Term Weight Loss

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • weight loss

Secondary Outcome Measures:
  • fitness
  • physical activity
  • dietary intake
  • mediators

Estimated Enrollment: 75
Study Start Date: June 2005
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Accepts Healthy Volunteers:   Yes
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.
  9. No exclusion criteria shall be based on race, ethnicity, or gender.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177593

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
University of Pittsburgh
Hoffmann-La Roche
Investigators
Principal Investigator: John M Jakicic, Ph.D. University of Pittsburgh
  More Information

Study ID Numbers: 0503021
Study First Received: September 13, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00177593  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Weight Loss
Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009