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Behavioural Intervention

LYFE MD app for Ulcerative Colitis (LYFEMD Trial)

N/A
Waitlist Available
Led By Maitreyi Raman, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 week
Awards & highlights

LYFEMD Trial Summary

This trial will assess the feasibility and acceptability of the LyfeMD app in individuals with CD and UC.

Eligible Conditions
  • Ulcerative Colitis
  • Crohn's Disease

LYFEMD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
24-item tool from the National Institute for Neurological Disorders and Stroke: Change is being assessed.
Behaviour compliance: Change is being assessed.
Generalized anxiety disorder 7-item (GAD-7) tool: Change is being assessed.
+5 more
Secondary outcome measures
24 hour ASA food recalls: Change is being assessed.
Fecal calprotectin: Change is being assessed.
Harvey Bradshaw Index (HBI) fro Crohn's disease: Change is being assessed.
+1 more

LYFEMD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
The INT group will meet with their health coach over the phone or video chat. The health coach will orient them to the LyfeMD, app and ensure the participant has received a nutrition plan in the app. They will be asked to complete the app assessment tools to design a personalized nutrition, physical activity and yoga and meditation program. They will set goals in each area they are interested in implementing. The health coach will then follow-up by phone, video or email 2 weeks after the initial meeting, then monthly with the patient for 2 more months (total of 4 meetings). The health coach will use the following schedule to discuss app related content: First visit nutrition content; second visit behaviour change tools; third visit Yoga, meditation and breathing plans, and; the fourth visit the physical activity plans. The health coach will also be available to answer questions when required using email. Goal attainment will be collected weekly within the app.
Group II: Conventional Management GroupActive Control1 Intervention
The CM group (n=22) will receive conventional care as well as a similar health coaching schedule as the intervention group. The health coach will meet the patient over the phone or video chat to outline their role over the next 3 months and to provide general nutrition guidelines using Canada's Food Guide and Alberta Health Services online resources. The health coach will then follow-up by phone, video chat or email 2 weeks after the initial meeting, then monthly with the patient for 2 more months (total of 4 meetings). The health coach session topics will be the same as the intervention group. For example, the second visit will provide online resources from Alberta Health Services focused on promoting behaviour change, the third visit will orient the patient to Alberta Health Services focused online stress management tools and the final visit will share online versions of the Canadian guidelines for physical activity and sedentary time.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,110 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
684 Patients Enrolled for Ulcerative Colitis
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,910,396 Total Patients Enrolled
32 Trials studying Ulcerative Colitis
425,975 Patients Enrolled for Ulcerative Colitis
Maitreyi Raman, MDPrincipal InvestigatorUniversity of Calgary
4 Previous Clinical Trials
223 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Alberta
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Digital Nutrition Therapy for Patients With IBD
Maitreyi Raman 2021. "Digital Nutrition Therapy for Patients With IBD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04653259.
All > Ibd
~11 spots leftby Apr 2025
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