Weight LossPhase 1/2NCT00177593
The Effect of HealthWear on Short-Term Weight Loss
A Phase 1/2 study testing behavioral weight loss in people with Weight Loss and Obesity, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity
- What is being tested?
- behavioral weight loss
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Sep 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15203
About this study
The purpose of this study is to examine the effect of a computer tracking system and energy expenditure device on weight loss in adults.
- Conditions
- Weight Loss, Obesity
- Being tested
- behavioral weight loss
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral weight lossBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Secondary outcomes (4)
fitness
physical activity
dietary intake
mediators
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- John M Jakicic, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177593
- Sponsor's protocol ID
- 0503021
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 3 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HealthWear on Short-Term Weight Loss
- ClinicalTrials.gov ID
- NCT00177593
- Acronym / sponsor ID
- 0503021
- Conditions
- Weight Loss, Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- Jun 2005
- Study completion
- Sep 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of a computer tracking system and energy expenditure device on weight loss in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral weight loss | Behavioural | – |
Primary outcome
weight loss
4 secondary outcomes
fitness
physical activity
dietary intake
mediators
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Jakicic, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing behavioral weight loss in people with Weight Loss and Obesity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.