Crohn Colitis · Crohn Disease · Crohn's Duodenitis · Crohn's Esophagitis · Crohn's Gastritis · Crohn's Ileocolitis · Crohn's Jejunitis · Inflammatory Bowel Diseases
Personalized Crohn’s Disease Risk Education for Unaffected Relatives
This randomized study examines whether personalized Crohn’s disease risk information delivered online affects behaviors and biomarkers in unaffected first-degree relatives of people with inflammatory bowel disease, compared with standard Crohn’s education.
Registry title: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
1 recruiting U.S. site ↓Study at a glance
- Age
- 14 Years and older
- Treatment
- Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool or Standard Crohn's Disease Education
- Design
- Randomized
- Central study contact
- Emily W Lopes, MD617-726-5560mghprecrohns@mgb.org
- Sponsor
- Massachusetts General Hospital
Research question
Is a web-based personalized Crohn’s disease risk tool feasible, and how does it affect risk-related behaviors and preclinical biomarkers compared with standard Crohn’s education?
Participant snapshot
Who the study is looking for
- The study is looking for people older than 14 years.
- The study is looking for people with at least one first-degree relative who has inflammatory bowel disease.
- The study is looking for people who do not already have inflammatory bowel disease.
- The study is looking for people without clinical signs or symptoms of inflammatory bowel disease identified using a modified Harvey-Bradshaw Index.
- The registry lists a recruiting study location at Massachusetts General Hospital in Boston.
Participation overview
What participation may involve
Participants receive either personalized online Crohn’s risk information plus standard education or standard education alone. The study assesses retention, motivation, behaviors, diet, physical activity, and selected inflammatory and antimicrobial biomarkers. What participation may involve: - Use the assigned web-based educational intervention. - Complete study questionnaires and a six-month survey. - Complete assessments of motivation, physical activity, diet, and smoking behavior at eight weeks and six months. - Undergo assessment of C-reactive protein, fecal calprotectin, and Crohn’s-associated antimicrobial biomarkers at eight weeks and six months.
Study interventions
What participants may receive or do
- Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool: A web-based tool that estimates relative and lifetime Crohn’s disease risk from specified risk factors, presents a personalized risk-factor summary, offers educational material about modifying those factors, and includes standard Crohn’s education.
- Standard Crohn's Disease Education: Online education covering Crohn’s disease prevalence, signs and symptoms, and treatment options. Comparator participants may choose to receive their personalized risk through the PRE-Crohn’s tool after completing the study.
Study design
How the comparison works
This is a randomized, parallel-group prevention study comparing a personalized online risk tool with standard Crohn’s disease education. Participants and study personnel are not reported as blinded. Participants are randomly assigned to one of two parallel groups; the registry does not report the assignment ratio. The study uses no masking, meaning group assignments are not blinded. The active comparison group receives standard online education about Crohn’s disease.
Reported activities
Procedures and tests
- Study questionnaires, including a six-month survey used to assess retention.
- Contemplation-ladder assessments of motivation to change smoking, diet, and physical activity.
- Physical-activity measurement in metabolic-equivalent hours per week.
- Dietary assessments covering fruit, vegetables, processed meat, fiber, and added sugar.
- Assessment of current smoking status and cigarettes smoked per day.
- C-reactive protein measurement.
- Fecal calprotectin measurement.
- PROMETHEUS IBD sgi Diagnostic panel testing for specified Crohn’s-associated antimicrobial biomarkers.
- Screening may involve confirming the absence of clinical inflammatory bowel disease signs or symptoms using a modified Harvey-Bradshaw Index.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be able to give informed consent.
- Participants must be able and willing to complete all study visits and procedures.
- Participants must be able to understand and complete study questionnaires.
- Participants must have at least one first-degree relative with Crohn’s disease, ulcerative colitis, or indeterminate or unclassified inflammatory bowel disease.
- Participants must be older than 14 years.
Possible reasons someone may not be able to join
- People unable to provide informed consent are excluded.
- People unable to complete all study visits and procedures are excluded.
- People unable to understand or complete study questionnaires are excluded.
- People already diagnosed with ulcerative colitis, Crohn’s disease, or indeterminate or unclassified inflammatory bowel disease are excluded.
- People with clinical signs or symptoms of inflammatory bowel disease identified by a modified Harvey-Bradshaw Index are excluded.
Important unknowns
What the record does not make clear
- The registry requires willingness to complete all visits but does not state how many visits occur, where they occur, or their schedule.
- Outcomes are assessed through six months, but the registry does not explicitly state each participant’s total participation duration.
- The registry does not explain whether participants must maintain or change medications, supplements, diet, smoking, or physical activity during the study.
- The registry does not report medication washout requirements.
- The registry reports biomarker assessments but does not state whether endoscopy or other invasive gastrointestinal procedures are required.
- The registry does not describe study-related costs, insurance billing, or which services the study covers.
- The registry does not state whether participants are compensated.
- The registry does not describe reimbursement or support for travel to the Boston study site.
- The interventions are web based, but the registry also refers to patient visits and does not state which activities can be completed remotely.
Before contacting the site
Questions for the study team
- What is the randomization ratio, and when will I learn which education group I was assigned to?
- What samples are needed for C-reactive protein, fecal calprotectin, and antimicrobial biomarker testing, and how often are they collected?
- How many visits are required, how long does each take, and which can be completed remotely?
- Does participation require endoscopy, imaging, or any procedure beyond questionnaires and biomarker assessments?
- Are participants expected to act on the tool’s education by changing diet, smoking, physical activity, or medication use?
- Are study services covered, is insurance billed, and are compensation or travel reimbursements available?
Before changing care
Questions for your gastroenterologist
- Could my current gastrointestinal symptoms or history affect whether the study team considers me unaffected by inflammatory bowel disease?
- Should any changes suggested by the risk tool be coordinated with you before I change medications, diet, smoking behavior, or physical activity?
- How should abnormal C-reactive protein, fecal calprotectin, or antimicrobial biomarker results be interpreted in my clinical context?
- What established evaluation or prevention options should I consider if I am concerned about my family history, whether or not I contact this study?
- How could you and the research team coordinate if study assessments identify symptoms or abnormal biomarkers?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Massachusetts General Hospital
- Organization class
- Other
- Organization study ID
- 2022p000905
- Lead sponsor
- Massachusetts General Hospital
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Prevention
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Intervention Arm
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
Interventions: Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
Active Comparator
Comparator arm
Standard Crohn's Disease Education
Interventions: Behavioral: Standard Crohn's Disease Education
Interventions
Behavioral
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
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.
Behavioral
Standard Crohn's Disease Education
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.
Eligibility
14 Years and older
All
Accepted
Inclusion criteria (5)
- Ability to give informed consentRegistry-derived · unreviewed
- Ability and willingness to comply with all patient visits and study-related proceduresRegistry-derived · unreviewed
- Ability to understand and complete study questionnairesRegistry-derived · unreviewed
- Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis/IBD unclassified)Registry-derived · unreviewed
- Individuals greater than 14 years of ageRegistry-derived · unreviewed
Exclusion criteria (5)
- Inability to provide informed consentRegistry-derived · unreviewed
- Inability to comply with all patient visits and study-related proceduresRegistry-derived · unreviewed
- Inability to understand or complete study questionnairesRegistry-derived · unreviewed
- Patients with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or indeterminate colitis/IBD unclassified)Registry-derived · unreviewed
- Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activityRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion
Time frame: 1.5 years and time of study completion
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.
Secondary outcome
Motivation to change smoking behavior
Time frame: 8 weeks and 6 months
We will measure change in contemplation ladder scores for motivation to change smoking behavior (yes/no for achieving a 1-point increase)
Secondary outcome
Motivation to change diet
Time frame: 8 weeks and 6 months
We will measure change in contemplation ladder scores for motivation to change diet (yes/no for achieving a 1-point increase)
Secondary outcome
Motivation to change physical activity
Time frame: 8 weeks and 6 months
We will measure change in contemplation ladder scores for motivation to change physical activity (yes/no for achieving a 1-point increase)
Secondary outcome
Change in physical activity
Time frame: 8 weeks and 6 months
We will measure change in physical activity (MET-hours/week)
Secondary outcome
Change in fruit intake
Time frame: 8 weeks and 6 months
We will measure change in fruit intake (servings/day)
Secondary outcome
Change in vegetable intake
Time frame: 8 weeks and 6 months
We will measure change in vegetable intake (servings/day)
Secondary outcome
Change in processed meat intake
Time frame: 8 weeks and 6 months
We will measure change in processed meat intake (servings/day)
Secondary outcome
Change in fiber intake
Time frame: 8 weeks and 6 months
We will measure change in fiber intake (grams/day)
Secondary outcome
Change in added sugar intake
Time frame: 8 weeks and 6 months
We will measure change in added sugar intake (grams/day)
Secondary outcome
Change in smoking behaviors
Time frame: 8 weeks and 6 months
We will measure change in smoking behaviors including current smoking vs non-smoking and cigarettes/day
Secondary outcome
Change in C-reactive protein (CRP; mg/L)
Time frame: 8 weeks and 6 months
We will measure change in CRP (mg/L)
Secondary outcome
Change in fecal calprotectin (mcg/g)
Time frame: 8 weeks and 6 months
We will measure change in fecal calprotectin (mcg/g)
Secondary outcome
Change in seropositivity for antimicrobial biomarkers
Time frame: 8 weeks and 6 months
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.
Recruiting locations in the United States
Massachusetts General Hospital
RecruitingBoston, Massachusetts, 02114, United States
Emily W. Lopes, MD617-726-5560mghprecrohns@mgb.org
Emily W. Lopes, MD
Central study contacts
Registry dates
- First posted
- Apr 18, 2022
- Primary completion
- Nov 2027
- Overall completion
- Nov 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.