CClinicalTrials.gg
CompletedNCT05721742Updated Sep 9, 2026

Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway

An interventional study of virtually administered dietitian consults for IBS patients. and IBS Group Online Session in IBS - Irritable Bowel Syndrome, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Irritable bowel syndrome is a functional bowel disorder that affects many Canadians. The syndrome involves abdominal pain and change in frequency or form of bowel movements, and these symptoms can lead to a decreased quality of life for patients. Primary care physicians are dissatisfied with current referral processes, and patients may wait a long time to receive the correct diagnosis. Diet is known to exacerbate symptoms of IBS. In Canada, accessing dietary treatment for IBS is a challenge due to lack of resources. Some patients lack access to dietary interventions, and others are given advice that is not evidenced based. Use of eHealth technology, such as virtual education delivered by a dietician, may allow for more widespread access to dietary interventions for IBS. Virtual education can include one on one dietary education, online group-based education, and the use of apps. Currently, there is a gap in knowledge whether dietary intervention for IBS, delivered virtually by a dietician, is effective in treating IBS.

02

Conditions studied

  • IBS - Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 71 is close to the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Recurrent abdominal pain on average at least 1 day/ week in the last 3 months associated with two or more of the following criteria: related to defecation, or association with a change in frequency of stool or associated with a change in form (appearance) of stool
  • Willingness to change diet
  • Access to a device for accessing virtual dietary education

Exclusion criteria

Exclusion Criteria:

  • New onset symptoms within past year in age 50 and above
  • Rectal bleeding
  • Inflammatory Bowel Disease
  • Unexplained recent weight loss
  • Gastrointestinal surgery with removal of gallbladder or segments of the bowel
  • Having an eating disorder
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Active comparator
    pre-existing online group education program for IBS

    This arm will be enrolled in the online course run by Happy Bellies Nutrition https://www.happybelliesnutrition.com/ibs-gentle-group-program. The Happy Bellies nutrition course has 5.5 hours of total video content and optional biweekly group calls via Zoom (45-minutes per session). This course is designed to take 12 weeks to complete. The participants would have access to the content for one year.

    Other: IBS Group Online Session

  • Experimental
    virtual dietitian consults for IBS patients

    This arm will receive consults with a virtual dietitian (60 minutes initial + 4 x30-minute follow-up appointment) by a dietitian who has had additional training in the dietary management of IBS.

    Other: virtually administered dietitian consults for IBS patients.

Interventions

  • Othervirtually administered dietitian consults for IBS patients.

    Participants will receive virtual one on one consults with a dietitian who has training in the dietary management of IBS.

  • OtherIBS Group Online Session

    IBS online group session run by Happy Bellies Nutrition

06

What researchers measure

Primary outcomes

  1. IBS Symptom Severity

    IBS Symptom Severity as measured by the "IBS Symptom Severity Score". Minimum: 75, Maximum: \>300. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and \> 300 respectively.

    Time frame: Baseline

  2. IBS Symptom Severity

    IBS Symptom Severity as measured by the "IBS Symptom Severity Score". Minimum: 75, Maximum: \>300. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and \> 300 respectively.

    Time frame: 5 months post-randomization

  3. IBS Specific Quality of Life

    IBS Specific Quality of Life as measured by the "IBS Quality of Life Questionnaire". Minimum: 0, Maximum: 100. Higher scores indicating better IBS specific quality of life.

    Time frame: Baseline

  4. IBS Specific Quality of Life

    IBS Specific Quality of Life as measured by the "IBS Quality of Life Questionnaire". Minimum: 0, Maximum: 100. Higher scores indicating better IBS specific quality of life.

    Time frame: 5 months post-randomization

  5. Patient Quality of Life

    Patient Quality of Life as measured by the "EQ 5D 5L Questionnaire". This questionnaire comprises the following five dimensions (ie. five questions): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension (question) has 5 levels (possible answers): 1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems and 5-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement. This results in a 1-digit number that expresses the level selected for that dimension, and the digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. There is also a visual analog scale which asks the patient to rate their overall health from 0-100, with 0 being the worst, and 100 being best possible health.

    Time frame: Baseline

  6. Patient Quality of Life

    Patient Quality of Life as measured by the "EQ 5D 5L Questionnaire". This questionnaire comprises the following five dimensions (ie. five questions): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension (question) has 5 levels (possible answers): 1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems and 5-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement. This results in a 1-digit number that expresses the level selected for that dimension, and the digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. There is also a visual analog scale which asks the patient to rate their overall health from 0-100, with 0 being the worst, and 100 being best possible health.

    Time frame: 5 months post-randomization

  7. Total number Inpatient services in the last 3 months

    Total number of inpatient services (admissions) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.

    Time frame: Baseline

  8. Total number Inpatient services in the last 3 months

    Total number of inpatient services (admissions) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.

    Time frame: 5 months post randomization

  9. Total number Outpatient appointments in the last 3 months

    Total number of outpatient services (outpatient appointments) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.

    Time frame: baseline

  10. Total number Outpatient appointments in the last 3 months

    Total number of outpatient services (outpatient appointments) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI.

    Time frame: 5 months post randomization

  11. Volume of referrals to Dietician

    Volume of referrals sent to the Virtual Dietician led 1 on 1 education session

    Time frame: 5 months post-randomization

  12. Volume of referrals to Online Group Session

    Volume of referrals sent to the online IBS group session, run by Happy Bellies Nutrition

    Time frame: 5 months post-randomization

  13. Patient satisfaction with the Virtual Dietician led 1 on 1 education session

    Patient satisfaction with the Virtual Dietician led 1 on 1 education session measured via questionnaires that were written by the study PI. The following statements will be presented, answers will follow a 5-point Likert scale where 1-strongly disagree 2-disagree 3-neutral 4-agree 5-strongly agree: 1. I feel confident managing my IBS 2. Overall, I was satisfied receiving dietary education through telehealth 3. It was easy to ask questions and get answers 4. I felt comfortable communicating with the dietitian using the telehealth system 5. It was easy to use the technology to access the services 6. I had no concerns about the privacy of my personal data 7. I would recommend this service to friends and family

    Time frame: 5 weeks post-randomization

  14. Volume of 1 on 1 dietary consults completed

    Volume of 1 on 1 dietary consults completed, records kept by study dieticians

    Time frame: 5 months post-randomization

  15. Number of online modules competed for Online Group Session

    Number of online modules competed for Online Group Session

    Time frame: 5 months post-randomization

  16. Number of sessions compared to proposed

    Number of virtual dietician led 1 on 1 education sessions compared to proposed

    Time frame: 5 months post-randomization

  17. Number of Modules accessed

    Number of Modules accessed for Online group session program run by Happy Bellies Nutrition

    Time frame: 5 months post-randomization

  18. Number of Modules completed

    Number of Modules completed for Online group session program run by Happy Bellies Nutrition

    Time frame: 5 months post-randomization

  19. Percentage participation in group session

    Percentage of participation for Online group session program run by Happy Bellies, Nutrition measured by how many participants contributed

    Time frame: 5 months post-randomization

  20. Quality Adjusted Life Years

    Quality adjusted life years as measured using the EQ 5D and client service receipt inventory

    Time frame: 5 months post-randomization

07

Study locations

1 site
  • QEII Health Sciences Centre
    Halifax, N.S. B3H 3A7, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05721742
Lead sponsor
Nova Scotia Health Authority
Collaborators
Research Nova Scotia
Responsible party
Jennifer Jones (Gastroenterologist, Associate Professor, Department of Medicine, Dalhousie University, Nova Scotia Health Authority) — Principal investigator
First posted
Feb 10, 2023
Start date
May 16, 2023
Primary completion
Sep 4, 2026
Completion
Sep 4, 2026
Last update
Sep 9, 2026

Oversight

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

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