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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNova Scotia Health Authority

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

New onset symptoms within past year in age 50 and above

Rectal bleeding

Inflammatory Bowel Disease

Unexplained recent weight loss

Trial design

Design model

Parallel

Treatments tested in this trial

  • virtually administered dietitian consults for IBS patients.

    Other intervention

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

  • IBS Group Online Session

    Other intervention

    IBS online group session run by Happy Bellies Nutrition

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: pre-existing online group education program for IBSActive comparator 1 intervention
Group B: virtual dietitian consults for IBS patientsExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Nova Scotia Health Authority

Lead sponsor

Research Nova Scotia

Collaborator