Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04653259
Status:
UNKNOWN
Last Update Posted:
2021-09-16
First Post:
2020-11-25
Brief Title:
Digital Nutrition Therapy for Patients With IBD
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Using the LyfeMD Application for Effective Maintenance of Remission and Improved Quality of Life in Crohns Disease and Ulcerative Colitis A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LYFEMD
Brief Summary:
Background Albertas 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 Ascends primary initiatives is the development of a digital health platform for patients living with both Crohns 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 Ramans 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 theyre 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
One of Ascends primary initiatives is the development of a digital health platform for patients living with both Crohns 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 Ramans 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 theyre 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 n44 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 GroupINT The INT group n22 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 n22 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 Canadas 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 yogameditation 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 ABCanada is inadequate to provide care to every patient with IBD in a convenient and personalized way
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 n44 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 GroupINT The INT group n22 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 n22 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 Canadas 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 yogameditation 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 ABCanada is inadequate to provide care to every patient with IBD in a convenient and personalized way
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None