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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutrition education | Behavioral | 15 minutes of surgery specific nutrition education provided by a Registered Dietitian. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | 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. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Bowden, PhD, RDN | Summit Brain,Spine,and Orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Summit Brain, Spine, and Orthopedics | Lehi | Utah | 84043 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34063333 | Background | 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. |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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.
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| Total study duration is about 6-7 weeks from preoperative to initial postoperative visit, with this outcome measure being addressed 2 days following surgery. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |