Nutritional Perihabilitation in Older Veterans Undergoing Surgery

VA Office of Research and Development

Status: Completed

Conditions: Nutritional Risk; Malnutrition; Abdominal Surgery

Treatments: Other: Education Control; Dietary Supplement: Protein enhanced nutrition intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03073811

IK2RX002348 (U.S. NIH Grant/Contract)

E2348-W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

PeriHab

Experimental group

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.

Treatment:

Dietary Supplement: Protein enhanced nutrition intervention

PoshControl

Active Comparator group

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.

Treatment:

Other: Education Control