Nutritional Perihabilitation in Older Veterans Undergoing Surgery

Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Abdominal Surgery; Nutritional Risk
• Intervention / Treatment: Dietary supplement: Protein enhanced nutrition intervention; Other: Education Control

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center, Durham, NC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PeriHab; 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.	Dietary supplement: Protein enhanced nutrition intervention; 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.; Other Names: Perihabilitation
Active Comparator: PoshControl; 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.	Other: Education Control; 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.; Other Names: PoshControl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.	Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained.	day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control	Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree	30-day post-surgery follow-up (endpoint)
Physical Function	Short physical performance battery - higher scores means a better physical performance (Total score = 0-12)	Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Readmission	determine from medical records	endpoint (30 days post-surgery)
Dietary Intake	Three day food records will be collected.	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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.	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Nutritional Risk Screener-2002	Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Patient Generated-Subjective Global Assessment	Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Discharge Location	determine from medical records	endpoint (30 days post-surgery)
Length of Stay	determine from medical records	endpoint (30 days post-surgery)
Emergency Department Readmission	Prevalence of emergency department admissions following surgery.	endpoint (30 days post-surgery)
Postoperative Complications	determine from medical records	endpoint (30 days post-surgery)
Albumin, g/dL	A measure of protein in the blood. Lower level may indicate infection or inflammation.	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Kathryn N. Starr, PhD, Durham VA Medical Center, Durham, NC

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: older adults; Veterans; protein supplementation; perioperative optimization; nutrition perihabilitation
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: E2348-W; IK2RX002348 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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