Longitudinal Study of Weight Change Following Lower Limb Amputation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00932399
First received: July 1, 2009
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition
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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • % Weight Change From Baseline [ Time Frame: At ~3 years after baseline ] [ Designated as safety issue: No ]
    Time window for 3 years is 31-39 months after baseline


Enrollment: 4549
Study Start Date: March 2010
Estimated Study Completion Date: June 2015
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   27 Years to 89 Years
Genders 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

Criteria

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 ClinicalTrials.gov identifier: NCT00932399

Locations
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Principal Investigator: Alyson J. Littman, PhD MPH VA Puget Sound Health Care System, Seattle
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov 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: October 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Amputation, Traumatic
Body Weight Changes
Body Weight
Signs and Symptoms
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014