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| ID | Type | Description | Link |
|---|---|---|---|
| IK2RX002348 | U.S. NIH Grant/Contract | View source |
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This research study will be conducted in two parts. The first part will consist of selecting appropriate screening and assessment tools for Veterans undergoing elective surgery and identifying the number of Veterans who are malnourished and at risk of malnutrition. The second portion of the study will be to determine if a protein-enhanced diet before and after surgery will improve function and postoperative outcomes and compare the results to an education control group.
In year 1 of the two-part research study, an observational, prospective study of 75 Veterans preparing for elective surgery will be conducted. The purpose of this study will be to select appropriate nutrition screening and assessment tools and to employ them to characterize malnutrition prevalence and severity and establish cut-off values associated with malnutrition in this population. In years 2-5 of the research two-part research study, a pilot randomized controlled trial will be conducted. The purpose of this study will be evaluate the feasibility, fidelity, and acceptability of a perioperative protein-enhanced intervention compared to an educational control. Veterans who are malnourished or at risk of being malnourished will be randomly assigned on a 1:1 ratio to either an education (nutritional counseling) control or high-protein perihabilitation arm. Participants in the high-protein perihabilitation arm will be provided with 30 grams of high quality protein supplements three times per day. The study will take place two weeks prior to an elective abdominal or GI surgery and will continue 4 weeks post surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PeriHab | Experimental | Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery. |
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| PoshControl | Active Comparator | Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein enhanced nutrition intervention | Dietary Supplement | Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. | Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained. | day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint) |
| Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control | Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree | 30-day post-surgery follow-up (endpoint) |
| Physical Function | Short physical performance battery - higher scores means a better physical performance (Total score = 0-12) | Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Readmission | determine from medical records | endpoint (30 days post-surgery) |
| Dietary Intake | Three day food records will be collected. |
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Inclusion Criteria:
Elective abdominal surgery
Referred to the VA Perioperative Optimization of Senior Health Clinic
Able to record dietary intake or has a proxy who can record dietary intake
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn N. Starr, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PeriHab | Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery. Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein three times a day for two weeks before surgery and four weeks after surgery. |
| FG001 | PoshControl | Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery. Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PeriHab | Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery. Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. | Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained. | Posted | Count of Participants | Participants | day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint) |
|
Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PeriHab | Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery. Protein enhanced nutrition intervention: Participants will be provided 30 grams of high quality protein three times a day for two weeks before surgery and four weeks after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgery site infection | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling in foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Starr, PhD, RD; Research Health Scientist | Durham VA Health Care System | 919-660-7571 | kathryn.starr2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2021 | Mar 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Education Control | Other | provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery. |
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| baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) |
| Handgrip Strength | Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials. | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) |
| Nutritional Risk Screener-2002 | Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) |
| Patient Generated-Subjective Global Assessment | Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) |
| Discharge Location | determine from medical records | endpoint (30 days post-surgery) |
| Length of Stay | determine from medical records | endpoint (30 days post-surgery) |
| Emergency Department Readmission | Prevalence of emergency department admissions following surgery. | endpoint (30 days post-surgery) |
| Postoperative Complications | determine from medical records | endpoint (30 days post-surgery) |
| Albumin, g/dL | A measure of protein in the blood. Lower level may indicate infection or inflammation. | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) |
| BG001 | PoshControl | Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery. Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Short Physical Performance Battery | SPPB total score is on a scale from 0 to 12, with a higher score indicating better physical function. | Mean | Standard Deviation | units on a scale |
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| Cancer Diagnosis | Count of Participants | Participants |
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| Body weight, lbs | Mean | Standard Deviation | lbs |
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| Body Mass Index, kg/m^2 | Mean | Standard Deviation | kg/m2 |
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Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery. Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery. |
|
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| Primary | Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control | Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree | Posted | Mean | Standard Deviation | units on a scale | 30-day post-surgery follow-up (endpoint) |
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| Primary | Physical Function | Short physical performance battery - higher scores means a better physical performance (Total score = 0-12) | Perihab (midpoint; n=23) - surgery was cancelled (n=3) PoshControl (midpoint; n=18) - surgery was cancelled (n=3), dropped (n=1); surgery time changed (n=2) Perihab (endpoint; n=18) - surgery was cancelled morning of surgery (n=2); death (n=1); COVID (n=2) PoshControl (n=16; endpoint) - surgery was cancelled morning of surgery (n=2); death (n=1); hospitalization (n=1) | Posted | Mean | Standard Deviation | score on a scale | Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery |
|
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| Secondary | Hospital Readmission | determine from medical records | Not Posted | Jun 2025 | endpoint (30 days post-surgery) | Participants |
| Secondary | Dietary Intake | Three day food records will be collected. | Not Posted | Jun 2025 | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | Participants |
| Secondary | Handgrip Strength | Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials. | Not Posted | Jun 2025 | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | Participants |
| Secondary | Nutritional Risk Screener-2002 | Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk | Not Posted | Jun 2025 | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | Participants |
| Secondary | Patient Generated-Subjective Global Assessment | Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status | Not Posted | Jun 2025 | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | Participants |
| Secondary | Discharge Location | determine from medical records | Not Posted | Jun 2025 | endpoint (30 days post-surgery) | Participants |
| Secondary | Length of Stay | determine from medical records | Not Posted | Jun 2025 | endpoint (30 days post-surgery) | Participants |
| Secondary | Emergency Department Readmission | Prevalence of emergency department admissions following surgery. | Not Posted | Jun 2025 | endpoint (30 days post-surgery) | Participants |
| Secondary | Postoperative Complications | determine from medical records | Not Posted | Jun 2025 | endpoint (30 days post-surgery) | Participants |
| Secondary | Albumin, g/dL | A measure of protein in the blood. Lower level may indicate infection or inflammation. | Not Posted | Jun 2025 | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | Participants |
| 1 |
| 26 |
| 2 |
| 26 |
| 1 |
| 26 |
| EG001 | PoshControl | Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery. Education Control: provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery. | 1 | 24 | 1 | 24 | 0 | 24 |
| Shortness of Breath and Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Morning of Surgery (midpoint) |
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| 30 day postop (endpoint) |
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