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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK136977-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| American College of Gastroenterology | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel disease. We hypothesize that personalized risk disclosure via the PRE-Crohn's educational tool is both feasible and successful in modifying behaviors associated with Crohn's disease risk and normalizing pre-clinical disease biomarkers when compared to standard Crohn's disease education. Broadly, completion of this project will also help elucidate the role of lifestyle and dietary factors in pre-clinical Crohn's disease development in high-risk individuals, and provide novel insight into potential strategies for disease prevention in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool |
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| Comparator arm | Active Comparator | Standard Crohn's Disease Education |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool | Behavioral | We will develop a web-based, personalized risk estimation for CD (PRE-Crohn's) tool to quantitate participants' relative risk (RR) and lifetime risk of CD based on known risk factors for disease. We will consider the following risk factors for Crohn's disease: body mass index (BMI); smoking history; NSAID use; intake of fruit, fiber, and added sugar; oral contraceptive use (females); antibiotic use; breast-feeding; pets in home; and anti-microbial biomarker positivity. This tool will also display a participants' personalized summary of their risk factors for CD as well as educational tools for modifying these factors. Construction of this tool is based on the Your Disease Risk tool developed by the Siteman Cancer Center at Washington University in St. Louis School of Medicine. The interventional group will also receive standard education about Crohn's disease (comparison group intervention) via the web-based tool. |
| Measure | Description | Time Frame |
|---|---|---|
| Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion | The total enrollment at 1.5 years and the retention rate recorded at the conclusion of the study will be measured based on completion of the 6-month survey. | 1.5 years and time of study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation to change smoking behavior | We will measure change in contemplation ladder scores for motivation to change smoking behavior (yes/no for achieving a 1-point increase) | 8 weeks and 6 months |
| Motivation to change diet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily W Lopes, MD | Contact | 617-726-5560 | mghprecrohns@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Emily Lopes, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33068181 | Background | Colditz GA, Dart H. Commentary: 20 years online with "Your Disease Risk". Cancer Causes Control. 2021 Jan;32(1):5-11. doi: 10.1007/s10552-020-01356-3. Epub 2020 Oct 17. |
| Label | URL |
|---|---|
| Your Disease Risk | View source |
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Aggregate-level results of from this study will be reported on clinicaltrials.gov. De-identified individual-level data will be uploaded to a separate controlled access repository and can be available upon reasonable request and per controlled access repository standard terms and procedures.
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All scientific data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
A controlled repository will be used to store and protect individual patient data. To access data arising from this project, users must complete a data request form and Data Use Agreement (DUA), which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in any unauthorized uses of the data. To get access to the data, the user must submit a valid scientific question, include a statistical analysis plan.
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| Standard Crohn's Disease Education | Behavioral | The comparison group will receive standard education about Crohn's disease, which will include information regarding the prevalence of disease, clinical presentation including signs and symptoms of disease, and treatment options including available medications. Upon completion of the study, the comparator arm will be given the option of receiving their personalized risk of Crohn's disease with the PRE-Crohn's tool as well. |
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We will measure change in contemplation ladder scores for motivation to change diet (yes/no for achieving a 1-point increase)
| 8 weeks and 6 months |
| Motivation to change physical activity | We will measure change in contemplation ladder scores for motivation to change physical activity (yes/no for achieving a 1-point increase) | 8 weeks and 6 months |
| Change in physical activity | We will measure change in physical activity (MET-hours/week) | 8 weeks and 6 months |
| Change in fruit intake | We will measure change in fruit intake (servings/day) | 8 weeks and 6 months |
| Change in vegetable intake | We will measure change in vegetable intake (servings/day) | 8 weeks and 6 months |
| Change in processed meat intake | We will measure change in processed meat intake (servings/day) | 8 weeks and 6 months |
| Change in fiber intake | We will measure change in fiber intake (grams/day) | 8 weeks and 6 months |
| Change in added sugar intake | We will measure change in added sugar intake (grams/day) | 8 weeks and 6 months |
| Change in smoking behaviors | We will measure change in smoking behaviors including current smoking vs non-smoking and cigarettes/day | 8 weeks and 6 months |
| Change in C-reactive protein (CRP; mg/L) | We will measure change in CRP (mg/L) | 8 weeks and 6 months |
| Change in fecal calprotectin (mcg/g) | We will measure change in fecal calprotectin (mcg/g) | 8 weeks and 6 months |
| Change in seropositivity for antimicrobial biomarkers | We will measure several Crohn's disease associated antimicrobial biomarkers including ASCA IgA and IgG, anti-OmpC, anti-CBir1, anti-A4-Fla2 and anti-FlaX will be assayed using the PROMETHEUS® IBD sgi Diagnostic® panel. Positivity for each of these components are defined as follows: ASCA IgA > 9.2 EU/mL; ASCA IgG > 11.9 EU/mL; anti-OmpC > 11.3 EU/mL; anti-CBir1 > 35.4 EU/mL; anti-A4-Fla2 > 32.4 EU/mL and anti-FlaX > 36.0 EU/mL. Total biomarker positivity (secondary outcome) will be defined as the presence of 1 or more positive individual biomarkers above. We will then assess for change in total biomarker positivity at 8 weeks and 6 months compared to baseline. | 8 weeks and 6 months |
| NIH Reporter Prevention of Crohns Disease in High-Risk Individuals | View source |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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