Longitudinal Study of Weight Change Following Lower Limb Amputation
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Department of Veterans Affairs
First received: July 1, 2009
Last updated: April 7, 2014
Last verified: April 2014
The purpose of this study is to assess weight change in a population of veterans with amputations. Little is known about the how weight changes following an amputation. It is widely believed that many patients experience weight gain following amputation. This study aims to identify magnitude of weight changes following amputation and determine characteristics associated with weight gain. Information on weight change trajectories would be useful to better understand long-term health consequences associated with amputation and to design and target interventions to encourage weight maintenance and general health promotion for groups at high risk of weight gain.
||Observational Model: Cohort
Time Perspective: Retrospective
||Weight Change, Physical Activity and Health Promotion in Veteran Amputees
Primary Outcome Measures:
- weight change [ Time Frame: In the 3 years after amputation ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||August 2010 (Final data collection date for primary outcome measure)
Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
No history of lower limb amputation
|Ages Eligible for Study:
||27 Years to 89 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Veterans who received care at a VISN20 medical facility between 1997 and 2008
- incident lower limb amputation during the study period (1/1997-12/2008) in VISN 20
- >= 1 plausible weight recoded in the medical record at baseline (defined as 8 weeks before amputation or 2-8 weeks post amputation)
- >=1 weight measured post amputation (2 months to 42 months post amputation)
"Unexposed" (comparison) cohort:
- no lower limb amputation during the study period
- no prior history of amputation
- >= 2 plausible recorded weights including at least one in the 2-6 weeks after their reference date ("baseline").
- Alive at least 18 months after "baseline"
- female (due to small number of women with lower limb amputations)
- lack information on any of the characteristics used for matching (e.g., birth year/age and height to calculate body mass index)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00932399
|VA Puget Sound Health Care System, Seattle
|Seattle, Washington, United States, 98108 |
||Alyson J. Littman, PhD MPH
||VA Puget Sound Health Care System, Seattle
No publications provided
||Department of Veterans Affairs
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 1, 2009
||April 7, 2014
||United States: Federal Government
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
Body Weight Changes
Signs and Symptoms