Longitudinal Study of Weight Change Following Lower Limb Amputation

Weight Change, Physical Activity and Health Promotion in Veteran Amputees

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.

Study Overview

• Status: Completed
• Conditions: Amputation Wound; Traumatic Amputation of Toe; Dysvascular Amputation of Lower Limb

• Study Type: Observational
• Enrollment (Actual): 4549

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Veterans who received care at a VISN20 medical facility between 1997 and 2008

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Weight Change From Baseline	Time window for 3 years is 31-39 months after baseline	At ~3 years after baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Publications and helpful links

General Publications

• Bouldin ED, Thompson ML, Boyko EJ, Morgenroth DC, Littman AJ. Weight Change Trajectories After Incident Lower-Limb Amputation. Arch Phys Med Rehabil. 2016 Jan;97(1):1-7.e1. doi: 10.1016/j.apmr.2015.09.017. Epub 2015 Oct 8.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 1, 2009
• First Submitted That Met QC Criteria: July 1, 2009
• First Posted (Estimate): July 3, 2009

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: January 13, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Weight; Body Weight Changes; Amputation, Traumatic
• Other Study ID Numbers: F6982-W