Recruiting

Digital Nutrition Therapy

Sponsor:

University of Calgary

Code:

NCT04653259

Conditions

Crohn Disease

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LYFE MD app

Study Details

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.

Conditions

Crohn Disease

Ulcerative Colitis

Study ID

NCT04653259

Start date

May 15, 2021

Status verified date

Sep, 2021

Completion date

Oct 15, 2022

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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.

no intervention: Conventional Management Group

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.

Interventions

LYFE MD app

LyfeMD app is a digital health platform for patients living with both Crohn's disease (CD) and Ulcerative colitis (UC). 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, 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 behaviour science to help patients change their habits, improve their health and reduce the burden IBD places on their lives.

Primary outcome measure

  • Short-form 12-items (SF-12): Change is being assessed. [ Time Frame: Baseline and 12 week ]
  • Perceived stress score 10-item measure (PSS-10): Change is being assessed. [ Time Frame: Baseline and 12 week ]
  • Pittsburgh sleep quality index a validated 10-item sleep score (PSQI): Change is being assessed. [ Time Frame: Baseline and 12 week ]
  • Godin, a validated 4-item tool: Change is being assessed. [ Time Frame: Baseline and 12 week ]
  • 24-item tool from the National Institute for Neurological Disorders and Stroke: Change is being assessed. [ Time Frame: Baseline and 12 week ]
  • Generalized anxiety disorder 7-item (GAD-7) tool: Change is being assessed. [ Time Frame: Baseline and 12 week ]
  • Patient health questionnaire 9-item (PHQ-9) tool: Change is being assessed. [ Time Frame: Baseline and 12 week ]
  • Behaviour compliance: Change is being assessed. [ Time Frame: Once every week starting from date of randomization upto week 12 ]

Central Contacts and Locations

Central contacts

Maitreyi Raman, MD

403-592-5020mkothand@ucalgary.ca

Lorian Taylor, PhD, RD

403-952-5154lorian.taylor@ucalgary.ca

Locations

TRW building, Foothills, University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Maitreyi Raman, MD

403-592-5020mkothand@ucalgary.ca

Lorian Taylor, PhD, RD

403-952-5154lorian.taylor@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Sep 16, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2021-09-16.