Digital Nutrition Therapy for Patients With IBD (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

No Placebo-Only Group

Summary

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

Eligible Conditions

Colitis
Crohn's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 week

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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