Digital Nutrition Therapy for Patients With IBD

NCT04653259 | Unknown DMC

• 1 other identifier: REB20-1534
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Short-form 12-items (SF-12): Change is being assessed.

  Assess quality of life

  Baseline and 12 week

• Perceived stress score 10-item measure (PSS-10): Change is being assessed.

  measure the stress level

  Baseline and 12 week

• Pittsburgh sleep quality index a validated 10-item sleep score (PSQI): Change is being assessed.

  Measure the sleep quality

  Baseline and 12 week

• Godin, a validated 4-item tool: Change is being assessed.

  Physical activity minutes will be measured, to estimate weekly physical activity minutes from both moderate and vigorous leisure-time activity.

  Baseline and 12 week

• 24-item tool from the National Institute for Neurological Disorders and Stroke: Change is being assessed.

  To measure the well being and positive aspect

  Baseline and 12 week

• Generalized anxiety disorder 7-item (GAD-7) tool: Change is being assessed.

  To measure the anxiety severity

  Baseline and 12 week

• Patient health questionnaire 9-item (PHQ-9) tool: Change is being assessed.

  To measure depression

  Baseline and 12 week

• Behaviour compliance: Change is being assessed.

  This will be measured by scoring how many goals the patients reports successfully tracking each week in the three different content areas. This is all done inside of the app.

  Once every week starting from date of randomization upto week 12

Secondary Outcomes (4)

• 24 hour ASA food recalls: Change is being assessed.

  Base line and 12 week

• Fecal calprotectin: Change is being assessed.

  Baseline and 12 week

• Harvey Bradshaw Index (HBI) fro Crohn's disease: Change is being assessed.

  Baseline and 12 week

• Partial-Mayo score for ulcerative colitis: Change is being assessed.

  Baseline and 12 week

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: LYFE MD app

Conventional Management Group

NO 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.

Interventions

LYFE MD app OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Pfizer: collaborator

Study Sites (1)

TRW building, Foothills, University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Maitreyi Raman, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maitreyi Raman, MD

CONTACT

403-592-5020; mkothand@ucalgary.ca

Lorian Taylor, PhD, RD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Director Clinician Investigator Program (CIP), Medical Director Alberta's Collaboration of Excellence for Nutrition in Digestive Diseases (Ascend) , Medical Director Nutrition Services

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 4, 2020
• Study Start: May 15, 2021
• Primary Completion: March 31, 2022
• Study Completion: October 15, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)