Clinical trial NCT04653259: Digital Nutrition Therapy for Patients With IBD
Official title: Using the LyfeMD Application for Effective Maintenance of Remission and Improved Quality of Life in Crohn's Disease and Ulcerative Colitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2020-12-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: Alberta's Center of Excellence for Nutrition in Digestive Diseases (Ascend) is dedicated to generating new discoveries regarding the link between nutrition and digestive diseases and mobilizing existing research to change the way physicians treat conditions such as inflammatory bowel disease, cirrhosis and intestinal failure. Ascend is a collaboration of excellence within the Department of Medicine, Division of Gastroenterology at both the University of Calgary and University of Alberta. Dr. Raman, PI, is the Director of Ascend.

One of Ascend's primary initiatives is the development of a digital health platform for patients living with both Crohn's disease (CD) and Ulcerative colitis (UC). Dr. Raman and her team have developed an app called LyfeMD, by translating leading scientific research into a practical and engaging digital format. LyfeMD is meant to help people live and thrive while managing their inflammatory disease with holistic, easy-to-implement, evidence based lifestyle therapies. LyfeMD is one app with multiple features - ranging from customized diet using anti-inflammatory principles identified from recent research led by Dr. Raman's team, and exercise plans to mindfulness and stress reduction programs. It helps patients make therapeutic diet choices to treat inflammation and provides stress reduction strategies when they feel unwell. The LyfeMD app also supports patients to maintain remission even when they're feeling well with trusted resources designed to keep them symptom free.

In addition to delivering personalized and interactive support, the app uses behavior science to help patients change their habits, improve their health and reduce the burden IBD places on their lives. With proprietary research and a team made up of internationally recognized leaders in the gastrointestinal field, LyfeMD is poised to be the trusted digital health solution for people living with IBD.

Detailed description: Study Objectives:

1. To identify if the LyfeMD app improves diet quality, perceived stress, depression, anxiety, well-being, quality of life, sleep, and physical activity minutes.
2. To identify if the LyfeMD app helps improve intestinal inflammation measured by fecal calprotectin in CD and UC patients in clinical remission.

Methods:

This 1-year study at the University of Calgary (n=44) will have a RCT study design. Participants will be randomly allocated to receive the intervention LyfeMD mobile application (INT) for 12-weeks or conventional management (CM) from the IBD clinic at the Foothills hospital.

Intervention Group(INT): The INT group (n=22) will meet with the health coach over the phone or video chat. The health coach will orient the participant to the LyfeMD app, answer technology related questions and ensure that the participant has received a nutrition plan in the app. Participants will be asked to complete the app assessment tools to design a personalized nutrition, physical activity and yoga and meditation program. Participants will set goals in each area that they are interested in implementing.

The health coach will then follow-up by phone, video chat or email 2 weeks after the initial meeting, then monthly with the participants 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.

Conventional Management (CM): 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 patrticipants 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 participant by phone, video chat or email 2 weeks after the initial meeting, then monthly for 2 more months (total of 4 meetings). The health coach session topics will be 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.

The health coach will be available to answer questions when required using email.

Following completion of the 12-week study, participants in the control group will receive complimentary access to the LyfeMD app for 12-weeks.

Both groups will meet with the study coordinator face to face at the start and end of the study (13th week). At this time, participants will be given all the study materials they need.

Relationship to Pfizer:

From a Pfizer perspective, the investigators recognize that Inflectra is growing in market share. The LyfeMD program will be used together, in a complementary way alongside biologic therapy. The recent diet study led by the principle investigator indicates that the customized diet using anti-inflammatory principles will induce remission in 6 weeks and maintain remission in patients with CD. The investigators would expect that combining diet therapy with biologics would bolster the effect of the biologic and longevity of remission. With the wellness additions (physical activity and yoga/meditation programs), the investigators predict patients will lead happier lives.

Investigators believe that the LyfeMD app will fill a current gap in the market. The availability of Registered Dietitian (RD), Exercise Physiologists, and Certified yoga and meditation instructors in AB/Canada is inadequate to provide care to every patient with IBD in a convenient and personalized way.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Patients with ileal, ileo-colonic, or colonic luminal CD and UC in clinical remission (Harvey Bradshaw Index \<5 or Partial Mayo Score \<3) will be invited to participate.
* Ability to provide informed consent
* Have smart phones to use the app

Exclusion Criteria:

* Patients more than 80 years old.
* Patients will be excluded if they are known to have upper GI Crohn's disease, fistulizing phenotype, \> 1 small bowel resection, colectomy, or any psychiatric or neurocognitive comorbidity that would limit compliance.

Primary outcomes:
measure: Short-form 12-items (SF-12): Change is being assessed.
timeFrame: Baseline and 12 week
measure: Perceived stress score 10-item measure (PSS-10): Change is being assessed.
timeFrame: Baseline and 12 week
measure: Pittsburgh sleep quality index a validated 10-item sleep score (PSQI): Change is being assessed.
timeFrame: Baseline and 12 week
measure: Godin, a validated 4-item tool: Change is being assessed.
timeFrame: Baseline and 12 week
measure: 24-item tool from the National Institute for Neurological Disorders and Stroke: Change is being assessed.
timeFrame: Baseline and 12 week
measure: Generalized anxiety disorder 7-item (GAD-7) tool: Change is being assessed.
timeFrame: Baseline and 12 week
measure: Patient health questionnaire 9-item (PHQ-9) tool: Change is being assessed.
timeFrame: Baseline and 12 week
measure: Behaviour compliance: Change is being assessed.
timeFrame: Once every week starting from date of randomization upto week 12
Secondary outcomes:
measure: 24 hour ASA food recalls: Change is being assessed.
timeFrame: Base line and 12 week
measure: Fecal calprotectin: Change is being assessed.
timeFrame: Baseline and 12 week
measure: Harvey Bradshaw Index (HBI) fro Crohn's disease: Change is being assessed.
timeFrame: Baseline and 12 week
measure: Partial-Mayo score for ulcerative colitis: Change is being assessed.
timeFrame: Baseline and 12 week
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: TRW building, Foothills, University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Maitreyi Raman, MD
role: PRINCIPAL_INVESTIGATOR
References: