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Completed

NCT Number: NCT05183607

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Virtual Nutrition Education

Other

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

Primary outcomes

  1. Nutritional Literacy

    Time frame: Baseline

    measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

  2. Nutritional Literacy

    Time frame: 1 week pre-surgery

    measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

  3. Nutritional Literacy

    Time frame: I month post Hospital discharge

    measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

Secondary outcomes

  1. Nutrition Status - MNA

    Time frame: Baseline

    participant nutritional status - Mini nutritional assessment

  2. Nutrition Status - MNA

    Time frame: 1 week pre-surgery

    participant nutritional status - Mini nutritional assessment

  3. Nutrition Status - MNA

    Time frame: 1 month post Hospital discharge

    participant nutritional status - Mini nutritional assessment

  4. Nutrition Status - BMI

    Time frame: Baseline

    participant nutritional status - Body Mass Index (BMI)

  5. Nutrition Status - BMI

    Time frame: 1 Week pre-surgery

    participant nutritional status - Body Mass Index (BMI)

  6. Nutrition Status - BMI

    Time frame: 1 Month post hospital discharge

    participant nutritional status - Body Mass Index (BMI)

  7. Quality of Life - physical function

    Time frame: Baseline

    modified Short Form - 36 questionnaire to measure physical function

  8. Quality of Life - physical function

    Time frame: 1 week pre-surgery

    modified Short Form - 36 questionnaire to measure physical function

  9. Quality of Life - physical function

    Time frame: 1 month post hospital discharge

    modified Short Form - 36 questionnaire to measure physical function

  10. Nutritional behaviour

    Time frame: Baseline

    3-Day Food Record

  11. Nutritional behaviour

    Time frame: 1 Week pre-surgery

    3-Day Food Record

  12. Nutritional behaviour

    Time frame: 1 month post hospital discharge

    3-Day Food Record

  13. Nutrition Status - PA

    Time frame: Baseline

    participant nutritional status - pre-albumin

  14. Nutrition Status - PA

    Time frame: 1 week pre-surgery

    participant nutritional status - pre-albumin

  15. Nutrition Status - PA

    Time frame: 1 month post hospital discharge

    participant nutritional status - pre-albumin

Sponsors and collaborators

Lead sponsor

St. Boniface Hospital

Other

Collaborators

  • University of Manitoba

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 10, 2022
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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