Nutrition EducationNCT06719492
Nutrition Education in Spine Surgery
A study testing nutrition education in people with Nutrition Education and Enhanced Recovery After Surgery, run by Jennifer Bowden at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Education, Enhanced Recovery After Surgery
- What is being tested?
- nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Summit Brain, Spine, and Orthopedics
Lehi, Utah, 84043
About this study
Official title: 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.
Read more
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.
- Being tested
- nutrition education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition educationBehavioural
15 minutes of surgery specific nutrition education provided by a Registered Dietitian.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition education | Experimental | 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. Receives: Behavioral: nutrition education |
| Control group with typical clinic education and care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each group with changes in PROMIS global and food frequency questionnaire.
At both the preoperative and postoperative visits, participants will be given PROMIS Global and food frequency questionnaires.
Measured: 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 (1)
Number of participants with treatment-related adverse events of nausea and vomiting as assessed by CTCAE v4.0.
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.
Measured: Total study duration is about 6-7 weeks from preoperative to initial postoperative visit, with this outcome measure being addressed 2 days following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start5 Nov 2024
- Primary completion10 Feb 2025
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Bowden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Bowden, Summit Brain,Spine,and Orthopedics
- Investigators
- Jennifer Bowden, PhD, RDN, Principal investigator, Summit Brain,Spine,and Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719492
- Sponsor's protocol ID
- SMI1351071
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34063333
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Impact of a Nutrition Supplement and Nutrition Education on Patient Acceptance and Outcomes in Spine Surgery
- ClinicalTrials.gov ID
- NCT06719492
- Acronym / sponsor ID
- SMI1351071
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Jennifer BowdenUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutrition education | Experimental | Behavioral: nutrition educationParticipants 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. |
| Control group with typical clinic education and care | No intervention | –Participants randomized to this group will receive typical clinic education and care. They will be offered an additional nutrition beverage if they choose it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition education15 minutes of surgery specific nutrition education provided by a Registered Dietitian. | Behavioural | Nutrition education |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 34063333Hirsch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Bowden, PhD, RDN principal investigator
Summit Brain,Spine,and Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition education in people with Nutrition Education and Enhanced Recovery After Surgery, run by Jennifer Bowden at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06719492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.