Nutrition Education in Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-05

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Knowledge of Nutritional Concerns in Physically Active Females

NCT05589077

Nutritional Deficiency

COMPLETED NA

Athlete Needs Assessment & Focus Groups

NCT06213350

Athlete Support

RECRUITING

Prepackaged Foods to Promote Weight Loss

NCT02136290

Overweight Obese

COMPLETED NA

Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep

NCT05413928

PreDiabetes Type 2 Diabetes Healthy

RECRUITING NA

Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes

NCT06837376

Nutritional Deficiency

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nutrition Education Enhanced Recovery After Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

nutrition education

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nutrition education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No