Nutrition Education in Spine Surgery

February 10, 2025 updated by: Jennifer Bowden

Development and Impact of a Nutrition Supplement and Nutrition Education on Patient Acceptance and Outcomes 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Lehi, Utah, United States, 84043
        • Summit Brain, Spine, and Orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition education
Participants randomized to this group will receive an additional 15 minutes of nutrition education focused on nutrition for surgical recovery. They will be offered an additional nutrition beverage if they choose it.
Behavioral: nutrition education
15 minutes of surgery specific nutrition education provided by a Registered Dietitian.
No Intervention: Control group with typical clinic education and care
Participants randomized to this group will receive typical clinic education and care. They will be offered an additional nutrition beverage if they choose it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jennifer Bowden

Investigators

  • Principal Investigator: Jennifer Bowden, PhD, RDN, Summit Brain,Spine,and Orthopedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Actual)

February 10, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • SMI1351071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Enhanced Recovery After Surgery

Clinical Trials on nutrition education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe