Digital nutrition therapy for patients with IBD

Summary

Alberta’s Center of Excellence for Nutrition in Digestive Diseases (Ascend) primary initiative is to develop 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. This app helps people manage their inflammatory bowel disease using nutrition, physical activity and yoga based therapies.

The purpose of the study is to:

1. To identify if using 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.
3. To identify if the LyfeMD app affects the function of regulatory macrophages

The study takes 12 weeks to complete.

You will have two in-person appointments with the study coordinator. One at the baseline and the other at the end of week 12. At baseline appointment, the study coordinator will sign you up for the study, ask you about your IBD history, measure your weight and height and have your blood sample taken. The study coordinator will provide the study material and explain how to collect the stool samples.

If you join this study, you will be assigned to either the standard medical care group or the LyfeMD group.

If you are in the LyfeMD group, you will receive a username and password to log into the app and book a time to meet with a health coach for about 1 hour. The health coach will get you started on the app over the phone or using MS Teams. They will help you install the app and can troubleshoot any issues you may have. Over the 12 weeks, they will help you set-up nutrition, physical activity, and a yoga-based program based on what you want to do. You will set goals in each area you are interested in. The health coach will follow-up with you by phone, video chat, or email 2 weeks after the initial visit, then monthly for 2 more months (total of 4 visits). Each call will take 15 to 30 minutes. At week 6 you will complete the same 30-minute surveys again. You will also be asked a few questions about your GI symptoms. This will take less than one minute.

If you are in the standard medical care group, you will be provided with general nutrition resources to review on your own. The research coordinator will follow-up with you by phone at week 6 to remind you to complete the 30-minute surveys again. You will also be asked a few questions about your GI symptoms. This will take less than a minute. The research coordinator will answer questions when required through email. Following completion of the 12-week study, you will receive free access to the LyfeMD app for 12 weeks. You will meet once with the health coach for orientation to the app and help set up your programs and goals.

After 12-weeks of being in the study, you will need to repeat the measures you did at baseline. You will repeat the 30-minute surveys, answer the questions about your GI symptoms, wear the activity tracker for one week and do another two 30-minute food recalls. You will collect your second stool sample, freeze it for 24 hours. At the end of week 12, you will have your second in-person appointment with the study coordinator. Your weight and height will be measured and blood samples will be taken. You will give the two stool samples to the study coordinator.

Eligibility

Currently recruiting participants: Yes

Eligible gender: Male, Female, Transgender, Other

Eligible ages: 18 to 80

Accepts healthy participants: Yes

Inclusion criteria:

Study participant inclusion criteria:

1. 18 years and older
2. Ability to give informed consent
3. Patients with ileal, ileo-colonic or colonic luminal CD and UC in clinical remission

Exclusion criteria:

Exclusion Criteria

1. Upper GI Crohn’s disease,
2. Fistulizing phenotype,
3. > 1 small bowel resection,
4. Colectomy,
5. Any psychiatric or neurocognitive comorbidity that would limit compliance.

Participate

Fill out the following form if you want to participate in this research

Method of contact

Additional information

Contact information

Research coordinator: Munazza Yousuf

Principal investigator:

Maitreyi Kothandaraman

Clinical trial:

Yes

REB-ID:

REB20-1534