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NCT00957008 · ClinicalTrials.gov registry record · NA
Lifestyle Education for Activity and Nutrition for a Leaner You
A NA study, sponsored by University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 197
- Enrollment target
NCT00957008 is a NA study that has completed, run by University of South Carolina. The registered enrollment target is 197 participants.
The verdict
NCT00957008, a NA study, has completed, sponsored by University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 197 participants
- Enrollment target
Study Summary
Although weight loss programs are effective in the short-term, maintaining weight loss is more challenging. Regularly tracking and logging physical activity (PA) and diet is related to greater improvements in PA and diet and to greater weight loss over time. Receiving continuous real-time feedback regarding calories burned and calories consumed could enhance weight loss maintenance. This study will examine whether a device that provides such feedback, called the SenseWear armband, enhances weight maintenance. 200 overweight adults aged 18 to 65 years will be randomly assigned to one of four groups: (1) a standard behavior change weight loss group-based program (14 group sessions over a 4 month period followed by 6 phone calls over a 5 month period), (2) a standard behavior change weight loss group-based program (15 group session over a 4 month period followed by 6 phone calls over a 5 month period) combined with the armband, (3) the armband alone (training in the use of the armband and a follow up telephone call), or (4) a self-directed weight loss control group. Participants will be recruited through USC through listserv emails, flyers, and worksite advertisements. Interested individuals will take part in a telephone screen, an orientation, a run-in visit (which includes 2 weeks of PA and dietary logging), a baseline assessment, and a randomization visit. The intervention will then take place over a 9-month period with eligible participants. Participants will take part in follow-up assessments at month 4 and 9. Assessments at all three times will include questionnaires assessing diet, PA, psychosocial factors related to diet and PA, and quality of life related measures. They will also have their fasting blood drawn to assess lipids, glucose, and insulin, and staff will measure their blood pressure, waist circumference (size), skinfold, height, and weight.
Interventions
- BEHAVIORAL Group weight loss program
- OTHER Group weight loss program plus use of the Senseware Armband
- DEVICE Use of the senseware armband alone program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2008-02 |
| Est. Completion | 2009-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00957008
The ClinicalTrials.gov registry entry for NCT00957008 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 197 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Carolina, which has 157 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Group weight loss program is the first listed.
NCT00957008 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00957008 about?
NCT00957008 is a clinical study titled "Lifestyle Education for Activity and Nutrition for a Leaner You". Although weight loss programs are effective in the short-term, maintaining weight loss is more challenging. Regularly tracking and logging physical activity (PA) and diet is related to greater improvements in PA and diet and to greater weight loss over time. Receiving continuous real-time feedback r...
What is the current status of trial NCT00957008?
This trial is currently completed. It is a NA study. The enrollment target is 197 participants. The study started on 2008-02. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00957008?
The interventions under investigation include: Group weight loss program (BEHAVIORAL), Group weight loss program plus use of the Senseware Armband (OTHER), Use of the senseware armband alone program (DEVICE).
Who is sponsoring clinical trial NCT00957008?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
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