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OpenTrials
Completed

NCT Number: NCT00177593

The Effect of HealthWear on Short-Term Weight Loss

The purpose of this study is to examine the effect of a computer tracking system and energy expenditure device on weight loss in adults.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-55 years of age.
  • Body mass index (BMI) between 25.0-39.9 kg/m2.
  • 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

  • Report losing >5% of current body weight in the previous 6 months.
  • Report participating in a research project involving weight loss or physical activity in the previous 6 months.
  • 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.)
  • Currently being treated for any medical condition that could impact body weight (i.e., diabetes mellitus, cancer, etc.).
  • History of myocardial infarction, or a history of undergoing heart surgery such as bypass or angioplasty.
  • Taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers).
  • Taking medication that could affect metabolism and/or contribute to a change in body weight (e.g., synthroid).
  • Being treated by a therapist for psychological issues or problems, taking pyschotropic medications, or receiving treatment with psychotropic medications within the previous 6 months.
  • No exclusion criteria shall be based on race, ethnicity, or gender.

Treatment and study plan

Behavioral weight loss

Behavioral

Primary outcomes

  1. weight loss

Secondary outcomes

  1. fitness

  2. physical activity

  3. dietary intake

  4. mediators

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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