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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
50
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.
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.
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States
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.
Time frame: 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
Time frame: 30-day post-surgery follow-up (endpoint)
Physical Function
Short physical performance battery - higher scores means a better physical performance (Total score = 0-12)
Time frame: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
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