Nutritional Perihabilitation in Older Veterans Undergoing Surgery

NCT03073811 | Completed Results

• 2 other identifiers: E2348-WIK2RX002348
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Nutritional Risk; Abdominal Surgery

Keywords

protein supplementation; older adults; nutrition perihabilitation; perioperative optimization; Veterans

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Hospital Readmission

  endpoint (30 days post-surgery)

• Dietary Intake

  baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

• Handgrip Strength

  baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

• Nutritional Risk Screener-2002

  baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

• Patient Generated-Subjective Global Assessment

  baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)

Study Arms (2)

PeriHab

EXPERIMENTAL

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

PoshControl

ACTIVE COMPARATOR

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

Interventions

Protein enhanced nutrition intervention DIETARY_SUPPLEMENT

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.

Also known as: Perihabilitation

PeriHab

Education Control OTHER

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.

Also known as: PoshControl

PoshControl

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Kathryn Starr, PhD, RD; Research Health Scientist
• Organization: Durham VA Health Care System

kathryn.starr2@va.gov

919-660-7571

Study Officials

• Kathryn N. Starr, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 8, 2017
• Study Start: June 20, 2017
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 1, 2025
• Results First Posted: January 31, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)