Nutritional Perihabilitation in Older Veterans Undergoing Surgery
Primary Purpose
Malnutrition, Nutritional Risk, Abdominal Surgery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein enhanced nutrition intervention
Education Control
Sponsored by
About this trial
This is an interventional health services research trial for Malnutrition focused on measuring protein supplementation, older adults, nutrition perihabilitation, perioperative optimization, Veterans
Eligibility Criteria
Inclusion Criteria:
Elective abdominal surgery
- upper GI
- colorectal
- hepatobiliary
- pancreatic
- intra-abdominal
- Abdominal aortic aneurysm
- Referred to the VA Perioperative Optimization of Senior Health Clinic
- Able to record dietary intake or has a proxy who can record dietary intake
Exclusion Criteria:
- Cognitive impairment
- Unwillingness to be randomized to either intervention arm, submit to study testing, or continuously participate in the intervention for six weeks
- Living in skilled nursing facility
- No access to telephone
Sites / Locations
- Durham VA Medical Center, Durham, NC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PeriHab
PoshControl
Arm Description
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Outcomes
Primary Outcome Measures
Change in physical function
Short physical performance battery
Secondary Outcome Measures
hospital readmission
determine from medical records
Change in Physical activity
3-axis accelerometer will be used to measure activity counts, step counts, and physical activity intensity.
Change in Dietary Intake
Three day food records will be collected.
serum albumin
serum
Change in Handgrip strength
Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials.
Change in Nutritional Risk Screener-2002
Validated Nutritoinal Risk Screener-2002 Questionnaire to determine nutritional risk
Change in Patient Generated-Subjective Global Assessment
Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status
Change in ICD-10 Malnutrition Code
Nutrition focused physical assessment will be conducted to determine the standard diagnostic classification of malnutrition
discharge location
determine from medical records
length of stay
determine from medical records
length of skilled care if needed
determine from medical records
emergency department readmission
determine from medical records
postoperative complications
determine from medical records
high sensitivity C-reactive protein
serum
tumor necrosis factor-alpha
serum
Full Information
NCT ID
NCT03073811
First Posted
February 23, 2017
Last Updated
April 13, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03073811
Brief Title
Nutritional Perihabilitation in Older Veterans Undergoing Surgery
Official Title
Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research study will be conducted in two parts. The first part will consist of selecting appropriate screening and assessment tools for Veterans undergoing elective surgery and identifying the number of Veterans who are malnourished and at risk of malnutrition. The second portion of the study will be to determine if a protein-enhanced diet before and after surgery will improve function and postoperative outcomes and compare the results to an education control group.
Detailed Description
In year 1 of the two-part research study, an observational, prospective study of 75 Veterans preparing for elective surgery will be conducted. The purpose of this study will be to select appropriate nutrition screening and assessment tools and to employ them to characterize malnutrition prevalence and severity and establish cut-off values associated with malnutrition in this population. In years 2-5 of the research two-part research study, a pilot randomized controlled trial will be conducted. The purpose of this study will be evaluate the feasibility, fidelity, and acceptability of a perioperative protein-enhanced intervention compared to an educational control. Veterans who are malnourished or at risk of being malnourished will be randomly assigned on a 1:1 ratio to either an education (nutritional counseling) control or high-protein perihabilitation arm. Participants in the high-protein perihabilitation arm will be provided with 30 grams of high quality protein supplements three times per day. The study will take place two weeks prior to an elective abdominal or GI surgery and will continue 4 weeks post surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Nutritional Risk, Abdominal Surgery
Keywords
protein supplementation, older adults, nutrition perihabilitation, perioperative optimization, Veterans
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PeriHab
Arm Type
Experimental
Arm Description
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
Arm Title
PoshControl
Arm Type
Active Comparator
Arm Description
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein enhanced nutrition intervention
Other Intervention Name(s)
Perihabilitation
Intervention Description
Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery.
Intervention Type
Other
Intervention Name(s)
Education Control
Other Intervention Name(s)
PoshControl
Intervention Description
provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
Primary Outcome Measure Information:
Title
Change in physical function
Description
Short physical performance battery
Time Frame
Baseline, day of surgery, 30-days post-surgery
Secondary Outcome Measure Information:
Title
hospital readmission
Description
determine from medical records
Time Frame
endpoint (30 days post-surgery)
Title
Change in Physical activity
Description
3-axis accelerometer will be used to measure activity counts, step counts, and physical activity intensity.
Time Frame
Baseline and endpoint (30-days post-surgery)
Title
Change in Dietary Intake
Description
Three day food records will be collected.
Time Frame
baseline, 3 days before surgery, and 30-days post-surgery
Title
serum albumin
Description
serum
Time Frame
baseline, day of surgery, and 30-days post-surgery
Title
Change in Handgrip strength
Description
Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials.
Time Frame
baseline, day of surgery, 30-days post-surgery
Title
Change in Nutritional Risk Screener-2002
Description
Validated Nutritoinal Risk Screener-2002 Questionnaire to determine nutritional risk
Time Frame
baseline, day of surgery, and 30-days post-surgery
Title
Change in Patient Generated-Subjective Global Assessment
Description
Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status
Time Frame
Baseline, day of surgery, and 30-days post-surgery
Title
Change in ICD-10 Malnutrition Code
Description
Nutrition focused physical assessment will be conducted to determine the standard diagnostic classification of malnutrition
Time Frame
baseline, day of surgery, and endpoint
Title
discharge location
Description
determine from medical records
Time Frame
endpoint (30 days post-surgery)
Title
length of stay
Description
determine from medical records
Time Frame
endpoint (30 days post-surgery)
Title
length of skilled care if needed
Description
determine from medical records
Time Frame
endpoint (30 days post-surgery)
Title
emergency department readmission
Description
determine from medical records
Time Frame
endpoint (30 days post-surgery)
Title
postoperative complications
Description
determine from medical records
Time Frame
endpoint (30 days post-surgery)
Title
high sensitivity C-reactive protein
Description
serum
Time Frame
baseline, day of surgery, and 30-days post-surgery
Title
tumor necrosis factor-alpha
Description
serum
Time Frame
baseline, day of surgery, and 30-days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective abdominal surgery
upper GI
colorectal
hepatobiliary
pancreatic
intra-abdominal
Abdominal aortic aneurysm
Referred to the VA Perioperative Optimization of Senior Health Clinic
Able to record dietary intake or has a proxy who can record dietary intake
Exclusion Criteria:
Cognitive impairment
Unwillingness to be randomized to either intervention arm, submit to study testing, or continuously participate in the intervention for six weeks
Living in skilled nursing facility
No access to telephone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn N. Starr, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Nutritional Perihabilitation in Older Veterans Undergoing Surgery
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