Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06719492

Nutrition Education in Spine Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Nutrition Education Enhanced Recovery After Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Summit Brain, Spine, and Orthopedics

Lehi, Utah, 84043, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Education

Behavioral

15 minutes of surgery specific nutrition education provided by a Registered Dietitian.

Primary outcomes

  1. Number of participants in each group with changes in PROMIS global and food frequency questionnaire.

    Time frame: 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 outcomes

  1. Number of participants with treatment-related adverse events of nausea and vomiting as assessed by CTCAE v4.0.

    Time frame: 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.

Other outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jennifer Bowden

Other

Registry information

Official study title

Development and Impact of a Nutrition Supplement and Nutrition Education on Patient Acceptance and Outcomes in Spine Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.