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Longitudinal Study of Weight Change Following Lower Limb Amputation

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: July 1, 2009
Last updated: January 13, 2016
Last verified: January 2016
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.

Amputation Wound Traumatic Amputation of Toe Dysvascular Amputation of Lower Limb

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Weight Change, Physical Activity and Health Promotion in Veteran Amputees

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • % Weight Change From Baseline [ Time Frame: At ~3 years after baseline ]
    Time window for 3 years is 31-39 months after baseline

Enrollment: 4549
Study Start Date: March 2010
Study Completion Date: January 2016
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Group 1
Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
Group 2
No history of lower limb amputation


Ages Eligible for Study:   27 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Veterans who received care at a VISN20 medical facility between 1997 and 2008

Inclusion Criteria:

"Exposed" cohort:

  • 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"

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00932399

United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Alyson J. Littman, PhD MPH VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT00932399     History of Changes
Other Study ID Numbers: F6982-W
Study First Received: July 1, 2009
Results First Received: October 2, 2014
Last Updated: January 13, 2016

Additional relevant MeSH terms:
Body Weight Changes
Amputation, Traumatic
Body Weight
Signs and Symptoms
Wounds and Injuries processed this record on September 25, 2017