Nutrition Education in Spine Surgery

Not Applicable

Active, not recruiting

• Conditions: Nutrition Education; Enhanced Recovery After Surgery

• Registration Number: NCT06719492
• Lead Sponsor: Jennifer Bowden

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-05
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Status Verified: 2025-02
• Primary Completion: 2025-02-10
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants in each group with changes in PROMIS global and food frequency questionnaire.	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.	At both the preoperative and postoperative visits, participants will be given PROMIS Global and food frequency questionnaires.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events of nausea and vomiting as assessed by CTCAE v4.0.	Total study duration is about 6-7 weeks from preoperative to initial postoperative visit, with this outcome measure being addressed 2 days following surgery.	Nausea and vomiting and initial drinking and eating times will be evaluated comparing participants with extra nutrition education to those with standard care. Presence and severity of nausea and vomiting, and initial eating and drinking times by hours after surgery will be reported by participants 2 days after surgery in a texted survey.

Trial Locations

Locations (1)

Summit Brain, Spine, and Orthopedics; 🇺🇸 Lehi, Utah, United States