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NCT01032733 · ClinicalTrials.gov registry record · Phase 2
Biological Effects of Weight Loss In Older, Obese Women
A Phase 2 study of Obesity and Sarcopenia, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01032733: Completed Phase 2 study of Obesity and Sarcopenia, sponsored by University of Florida.
NCT01032733 is a Phase 2 study of Obesity and Sarcopenia that has completed, run by University of Florida. The registered enrollment target is 34 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01032733, a Phase 2 study of Obesity and Sarcopenia, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Obesity and sedentary lifestyle are associated with physical impairments and biological changes in older adults. Weight loss combined with exercise may reduce inflammation and may improve physical functioning in older adults who are overweight or obese and sedentary. However, the mechanisms by which weight change and exercise influence physical functioning and sarcopenia remain largely understudied. ions). In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions each week throughout the entire study. During each exercise session, participants engaged in both aerobic activities (i.e., walking) and lower body resistance training of moderate intensity. The participants in the educational control group attended monthly health education lectures on topics relevant to older adults. It was hypothesized that participants assigned to the WL+E intervention would 1) lose a larger amount of weight, 2) improve their physical function levels, and 3) reduce levels of oxidative stress and inflammation to a greater degree than participants assigned to the Educational Control group. Outcomes are: 1) body weight, 2) walking speed (assessed by 400 meter walk test), 3) the Short Physical Performance Battery \[SPPB\], and 4) knee extension isokinetic strength. The objectives of this pilot study are fourfold: 1) to demonstrate the feasibility, acceptability, and efficacy of the proposed WL+E intervention in a sample of 40 sedentary, obese older adults with impaired physical functioning; 2) to examine the biological effects of the intervention on inflammatory processes, oxidative stress, apoptosis, sarcopenia, muscle and body composition, muscle strength, and functional performance; 3) to determine whether the expected beneficial effects of the WL+E intervention on physical functioning are mediated by changes in inflammation, apoptosis, and sarcopenia; and 4) to determine the effect size of the WL+E intervention on key outcome
Primary Outcome
Walking speed was assessed at baseline and 24-week assessment by the 400 Meter Walk Test, during which participants were asked to complete a standard walking course at their usual pace. Participants were permitted to stop during the walk but were not allowed to sit or receive help from others and were required to complete the course in 15 minutes.
Conditions Studied
Interventions
- BEHAVIORAL Lifestyle Counseling
- OTHER Educational Control
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT01032733 record still lists
NCT01032733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Lifestyle Counseling is the first listed.
NCT01032733 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01032733 about?
NCT01032733 is a clinical study titled "Biological Effects of Weight Loss In Older, Obese Women". Obesity and sedentary lifestyle are associated with physical impairments and biological changes in older adults. Weight loss combined with exercise may reduce inflammation and may improve physical functioning in older adults who are overweight or obese and sedentary. However, the mechanisms by which...
What is the current status of trial NCT01032733?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2006-09. Estimated completion is 2009-10.
What conditions does trial NCT01032733 study?
This clinical trial studies the following conditions: Obesity, Sarcopenia.
What interventions are being tested in trial NCT01032733?
The interventions under investigation include: Lifestyle Counseling (BEHAVIORAL), Educational Control (OTHER).
Who is sponsoring clinical trial NCT01032733?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01032733 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01032733's enrollment target sits among peer trials
34 829th of 1053 higher than 221 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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