Clinical trial NCT06719492: Nutrition Education in Spine Surgery
Official title: Development and Impact of a Nutrition Supplement and Nutrition Education on Patient Acceptance and Outcomes in Spine Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nutrition Education
Enhanced Recovery After Surgery
Lead sponsor: Summit Brain,Spine,and Orthopedics
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives additional nutrition education, the other (control) group receives typical clinic care. Both groups have an option to include a supplemental nutritional beverage if they choose.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this interventional study is to learn if having 15 minutes of surgery related nutrition education changes the food choices participants make during the time right before and after a spine surgery in participants who have a surgery with Dr. John Edwards. The main questions it aims to answer are:

* Does nutrition education at a participant's preoperative appointment help them choose healthier foods and drinks that help their recovery from surgery?
* Does choosing to drink some extra nutrients before and after surgery help participants feel better and make it easier to have other foods and liquids after surgery? Researchers will compare participants getting extra education with those in a control group who have normal instructions from the clinic to see if extra education makes a difference in people's food choices. Researchers will also look at how well participants do with the extra nutrition they get before and after surgery, and if choosing to include it changes with the extra education.

Participants will:

* Complete 2 surveys (PROMIS global and food frequency) at both their preoperative and postoperative appointments
* Complete one survey 2 days after their surgery asking about how well they did with liquids and solid foods in the 24 hours after surgery
* Choose whether or not they decide to have a drink with extra nutrients before and after surgery, and let the researchers know what they chose.


Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Patient of Dr. John Edwards undergoing spine surgery
* Patient is willing and able to complete all study requirements, including any education and follow up appointments

Exclusion Criteria:

* Under 18 years of age or pregnant
* Known allergies or intolerances to any supplement ingredients
* Patients deemed medically unstable by Dr. Edwards
* Patients with uncontrolled diabetes, as identified as Hemoglobin A1C\>7.5
* Patients unwilling or unable to complete all study requirements including any education and follow up appointments

Primary outcomes:
measure: Number of participants in each group with changes in PROMIS global and food frequency questionnaire.
timeFrame: The study starts at the preoperative visit, typically 2 weeks prior to surgery, and ends at the first postoperative visit, which is typically 4 weeks after surgery for a total study duration of about 6-7 weeks.
Secondary outcomes:
measure: Number of participants with treatment-related adverse events of nausea and vomiting as assessed by CTCAE v4.0.
timeFrame: Total study duration is about 6-7 weeks from preoperative to initial postoperative visit, with this outcome measure being addressed 2 days following surgery.
Other outcomes:
measure: Participant satisfaction and learning as measured by change in food frequency questionnaire responses as well as time of initial food and liquid consumption after surgery.
timeFrame: The study starts at the preoperative visit, typically 2 weeks prior to surgery, and ends at the first postoperative visit, which is typically 4 weeks after surgery for a total study duration of about 6-7 weeks.
Locations:
city: Lehi
country: United States
facility: Summit Brain, Spine, and Orthopedics
state: Utah
Study officials:
affiliation: Summit Brain,Spine,and Orthopedics
name: Jennifer Bowden, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hirsch KR, Wolfe RR, Ferrando AA. Pre- and Post-Surgical Nutrition for Preservation of Muscle Mass, Strength, and Functionality Following Orthopedic Surgery. Nutrients. 2021 May 15;13(5):1675. doi: 10.3390/nu13051675.