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CompletedNCT05183607Updated Apr 11, 2023

A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study Protocol

An interventional study of Virtual Nutrition Education in Nutritional Deficiency, sponsored by St. Boniface Hospital. Completed at 1 site in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by St. Boniface Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Nutritional Deficiency

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 20 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

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Lead sponsor

St. Boniface Hospital is the lead sponsor of 32 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 years or older
  • undergoing non-emergent/elective cardiac surgery

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Virtual nutritional Intervention

    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

    Other: Virtual Nutrition Education

Interventions

  • OtherVirtual Nutrition Education

    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

06

What researchers measure

Primary outcomes

  1. Nutritional Literacy

    measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

    Time frame: Baseline

  2. Nutritional Literacy

    measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

    Time frame: 1 week pre-surgery

  3. Nutritional Literacy

    measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

    Time frame: I month post Hospital discharge

Secondary outcomes

  1. Nutrition Status - MNA

    participant nutritional status - Mini nutritional assessment

    Time frame: Baseline

  2. Nutrition Status - MNA

    participant nutritional status - Mini nutritional assessment

    Time frame: 1 week pre-surgery

  3. Nutrition Status - MNA

    participant nutritional status - Mini nutritional assessment

    Time frame: 1 month post Hospital discharge

  4. Nutrition Status - BMI

    participant nutritional status - Body Mass Index (BMI)

    Time frame: Baseline

  5. Nutrition Status - BMI

    participant nutritional status - Body Mass Index (BMI)

    Time frame: 1 Week pre-surgery

  6. Nutrition Status - BMI

    participant nutritional status - Body Mass Index (BMI)

    Time frame: 1 Month post hospital discharge

  7. Quality of Life - physical function

    modified Short Form - 36 questionnaire to measure physical function

    Time frame: Baseline

  8. Quality of Life - physical function

    modified Short Form - 36 questionnaire to measure physical function

    Time frame: 1 week pre-surgery

  9. Quality of Life - physical function

    modified Short Form - 36 questionnaire to measure physical function

    Time frame: 1 month post hospital discharge

  10. Nutritional behaviour

    3-Day Food Record

    Time frame: Baseline

  11. Nutritional behaviour

    3-Day Food Record

    Time frame: 1 Week pre-surgery

  12. Nutritional behaviour

    3-Day Food Record

    Time frame: 1 month post hospital discharge

  13. Nutrition Status - PA

    participant nutritional status - pre-albumin

    Time frame: Baseline

  14. Nutrition Status - PA

    participant nutritional status - pre-albumin

    Time frame: 1 week pre-surgery

  15. Nutrition Status - PA

    participant nutritional status - pre-albumin

    Time frame: 1 month post hospital discharge

07

Study locations

1 site
  • St. Boniface General Hospital
    Winnipeg, Manitoba R2H 2A6, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05183607
Lead sponsor
St. Boniface Hospital
Collaborators
University of Manitoba
Responsible party
Dr. Rakesh C. Arora (Section Head and Regional Lead - Cardiac Surgery, St. Boniface Hospital) — Principal investigator
First posted
Jan 10, 2022
Start date
Jan 28, 2022
Primary completion
Dec 23, 2022
Completion
Feb 28, 2023
Last update
Apr 11, 2023

Study contacts

Rakesh Arora
principal investigator · University of Manitoba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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