Nutritional DeficiencyNCT05183607
A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study Protocol
A study testing Virtual Nutrition Education in people with Nutritional Deficiency, run by St. Boniface Hospital at 1 site in Canada.
Trial summary
This feasibility study will look to identify the impact that a remote/virtual nutritional intervention can have on nutrition literacy and knowledge retention of the cardiac surgery patient. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Nutritional Deficiency
- What is being tested?
- Virtual Nutrition Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- undergoing non-emergent/elective cardiac surgery
Who cannot join
- not able to communicate in English (read or write)
- in-patients (urgent or emergent care)
- patients who self report protein supplementation on a regular basis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study
This feasibility study will look to identify the impact that a remote/virtual nutritional intervention can have on nutrition literacy and knowledge retention of the cardiac surgery patient.
Read the detailed description
The proposed VIP study will utilize an interventional feasibility design to implement and evaluate the impact of a virtual nutrition intervention prehab program on cardiac surgery patients. The VIP study looks to measure patient adherence and acceptability, and practicality of the remote platform in hopes it will illicit change to the current standard of nutrition care being provided to cardiac surgery patients.
The current standards of care do not call for dietitian involvement for cardiac surgery patients' pre-surgery and little to no involvement for patients not receiving CABG surgery. This feasibility study looks to address this gap in current patient nutrition care.
The study intervention will provide eligible patients (n=20) with access to four 25-30 minute virtual sessions with a registered dietitian during the two-week period prior to surgery. The dietitian will provide the patient with nutrition counseling prior to the patient's elective cardiac surgery. Zoom (or equivalent) software will be utilized as a remote platform to connect the dietitian virtually with participants during all sessions. The four sessions will follow the same presentation format and will provide all participants with identical nutrition education with curriculum content progressing in each subsequent session. Each session will be comprised of protein education and goal setting, with education content building on previous sessions with a goal of improving patient protein intake perioperatively.
Data will be collected on: (1) participant demographics, (2) physical function, (3) nutritional status and (4) nutrition literacy.
- Conditions
- Nutritional Deficiency
- Being tested
- Virtual Nutrition Education
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Nutrition EducationOther
4 interventional sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely
| Study group | Role | What they receive |
|---|---|---|
| Virtual nutritional Intervention | Experimental | This arm will receive the virtual nutritional intervention consisting of 4 - 30 minute sessions to educate cardiac surgery patients before their date of surgery. Each session will provide a different theme such as: 1) nutritional assessment, 2) protein intake education, 3) nutritional adequacy prior to surgery, and 4) protein and nutrition intake post surgery Receives: Other: Virtual Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Literacy
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Measured: Baseline
Nutritional Literacy
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Measured: 1 week pre-surgery
Nutritional Literacy
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Measured: I month post Hospital discharge
Secondary outcomes (15)
Nutrition Status - MNA
participant nutritional status - Mini nutritional assessment
Measured: Baseline
Nutrition Status - MNA
participant nutritional status - Mini nutritional assessment
Measured: 1 week pre-surgery
Nutrition Status - MNA
participant nutritional status - Mini nutritional assessment
Measured: 1 month post Hospital discharge
Nutrition Status - BMI
participant nutritional status - Body Mass Index (BMI)
Measured: Baseline
Nutrition Status - BMI
participant nutritional status - Body Mass Index (BMI)
Measured: 1 Week pre-surgery
Nutrition Status - BMI
participant nutritional status - Body Mass Index (BMI)
Measured: 1 Month post hospital discharge
Quality of Life - physical function
modified Short Form - 36 questionnaire to measure physical function
Measured: Baseline
Quality of Life - physical function
modified Short Form - 36 questionnaire to measure physical function
Measured: 1 week pre-surgery
Quality of Life - physical function
modified Short Form - 36 questionnaire to measure physical function
Measured: 1 month post hospital discharge
Nutritional behaviour
3-Day Food Record
Measured: Baseline
Nutritional behaviour
3-Day Food Record
Measured: 1 Week pre-surgery
Nutritional behaviour
3-Day Food Record
Measured: 1 month post hospital discharge
Nutrition Status - PA
participant nutritional status - pre-albumin
Measured: Baseline
Nutrition Status - PA
participant nutritional status - pre-albumin
Measured: 1 week pre-surgery
Nutrition Status - PA
participant nutritional status - pre-albumin
Measured: 1 month post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start28 Jan 2022
- Primary completion23 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeficiencyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely while in the comfort of their own residence or where it is deemed to be comfortable and safe.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Principal investigator, Dr. Rakesh C. Arora, St. Boniface Hospital
- Investigators
- Rakesh Arora, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183607
- Sponsor's protocol ID
- HS25164 (H2021:336)
- Status last verified
- Apr 2023
- First submitted
- 22 Dec 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study
- ClinicalTrials.gov ID
- NCT05183607
- Acronym / sponsor ID
- HS25164 (H2021:336)
- Conditions
- Nutritional Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 10 Jan 2022 (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.
This feasibility study will look to identify the impact that a remote/virtual nutritional intervention can have on nutrition literacy and knowledge retention of the cardiac surgery patient.
Detailed description
The proposed VIP study will utilize an interventional feasibility design to implement and evaluate the impact of a virtual nutrition intervention prehab program on cardiac surgery patients. The VIP study looks to measure patient adherence and acceptability, and practicality of the remote platform in hopes it will illicit change to the current standard of nutrition care being provided to cardiac surgery patients.
The current standards of care do not call for dietitian involvement for cardiac surgery patients' pre-surgery and little to no involvement for patients not receiving CABG surgery. This feasibility study looks to address this gap in current patient nutrition care.
The study intervention will provide eligible patients (n=20) with access to four 25-30 minute virtual sessions with a registered dietitian during the two-week period prior to surgery. The dietitian will provide the patient with nutrition counseling prior to the patient's elective cardiac surgery. Zoom (or equivalent) software will be utilized as a remote platform to connect the dietitian virtually with participants during all sessions. The four sessions will follow the same presentation format and will provide all participants with identical nutrition education with curriculum content progressing in each subsequent session. Each session will be comprised of protein education and goal setting, with education content building on previous sessions with a goal of improving patient protein intake perioperatively.
Data will be collected on: (1) participant demographics, (2) physical function, (3) nutritional status and (4) nutrition literacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely while in the comfort of their own residence or where it is deemed to be comfortable and safe.
| Arm | Type | Receives |
|---|---|---|
| Virtual nutritional Intervention | Experimental | Other: Virtual Nutrition EducationThis arm will receive the virtual nutritional intervention consisting of 4 - 30 minute sessions to educate cardiac surgery patients before their date of surgery. Each session will provide a different theme such as: 1) nutritional assessment, 2) protein intake education, 3) nutritional adequacy prior to surgery, and 4) protein and nutrition intake post surgery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- undergoing non-emergent/elective cardiac surgery
Key exclusion criteria (3 listed)
- not able to communicate in English (read or write)
- in-patients (urgent or emergent care)
- patients who self report protein supplementation on a regular basis
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 |
|---|---|---|
| Virtual Nutrition Education4 interventional sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely | Other | Virtual nutritional Intervention |
Primary outcome
Nutritional Literacy
Time frame: Baseline
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Nutritional Literacy
Time frame: 1 week pre-surgery
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Nutritional Literacy
Time frame: I month post Hospital discharge
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
15 secondary outcomes
Nutrition Status - MNA
Time frame: Baseline
Nutrition Status - MNA
Time frame: 1 week pre-surgery
Nutrition Status - MNA
Time frame: 1 month post Hospital discharge
Nutrition Status - BMI
Time frame: Baseline
Nutrition Status - BMI
Time frame: 1 Week pre-surgery
Nutrition Status - BMI
Time frame: 1 Month post hospital discharge
Quality of Life - physical function
Time frame: Baseline
Quality of Life - physical function
Time frame: 1 week pre-surgery
Quality of Life - physical function
Time frame: 1 month post hospital discharge
Nutritional behaviour
Time frame: Baseline
Nutritional behaviour
Time frame: 1 Week pre-surgery
Nutritional behaviour
Time frame: 1 month post hospital discharge
Nutrition Status - PA
Time frame: Baseline
Nutrition Status - PA
Time frame: 1 week pre-surgery
Nutrition Status - PA
Time frame: 1 month post hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- 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.
Rakesh Arora principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Nutrition Education in people with Nutritional Deficiency, run by St. Boniface Hospital at 1 site in Canada.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 11 Apr 2023. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nutritional Literacy (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2023.