Recruiting

Lifestyle Modifications & Advanced Therapies

Sponsor:

Massachusetts General Hospital

Code:

NCT07168499

Conditions

IBD (Inflammatory Bowel Disease)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet Management

Stress Management

Study Details

Brief summary:

Inflammatory Bowel Disease (IBD), which includes Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The goal of this single site, pragmatic, randomized trial is to answer if combining lifestyle modifications (mindfulness/stress management + nutrition support) with advanced therapies for induction and maintenance of clinical remission in CD and UC as evaluated by disease activity scores in patients with active CD and UC.

Researchers will compare 4 study arms (Group 1, Group 2, Group 3, and Group 4) to see if combining lifestyle modifications with advanced therapies for induction and maintenance will show improvement in condition as evaluated by disease activity scores.

Groups:

1. Group A - Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist within the first month of advanced therapy initiation and another visit with both parties 4+/-2 weeks after the first intervention visit.
2. Group B - Subjects will receive a visit with an IBD dietician within the first month of advanced therapy initiation and another visit 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes).
3. Group C - Subjects will receive a visit with an IBD psychologist within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD dietician after 2 months (after assessment of our primary outcomes).
4. Group D - Subjects will be offered a visit with an IBD GI psychologist and IBD dietician after 3 months (after assessment of our primary outcomes).

All subjects will be asked to complete a set of questionnaires and have the option to give blood and stool samples throughout the life of their participation in the study at certain visits.

Conditions

IBD (Inflammatory Bowel Disease)

Study ID

NCT07168499

Start date

Sep 15, 2025

Status verified date

Nov, 2025

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
2. At least 18 years of age
3. Established diagnosis of CD, UC, or IBD-unspecified
4. Recent (within 6 months) objective evidence of active IBD on colonoscopy or intestinal ultrasound or cross-sectional imaging or elevated inflammatory markers (CRP)
5. Initiating advanced therapy (anti-TNF agents, anti-integrin agents, anti-IL12/23, anti-IL23 agents, S1P receptor modulators, JAK inhibitors) for IBD per usual clinical care within 2 weeks of baseline/randomization, regardless of prior exposure to advanced therapies or disease duration
6. Other non-biologic IBD medications must remain stable during the treatment period and no medication changes are planned with the exception of tapering of corticosteroids.
7. Current disease activity defined as a Harvey Bradshaw index > 4 at baseline (week 0) for CD subjects or Simple Clinical Colitis Activity Index > 2 at baseline (week 0) for UC subjects or having had a recent exacerbation being treated with systemic steroids or budesonide.

Exclusion Criteria:

1. Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.
2. Initiation of advanced therapy for extra-intestinal symptoms alone
3. Known eating disorders
4. Already receiving dietary therapy or stress management interventions
5. Severe untreated psychiatric comorbidity including history of suicidal thoughts
6. Evidence of untreated infection (e.g. Clostridium difficile)
7. Presence of stoma or J-pouch
8. Female subjects who are pregnant, lactating, or intending to become pregnant during the study period
9. On total parental nutrition (TPN) or already following a therapeutic diet for IBD.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Group A - Combined diet + stress management

Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist (whether in person or virtual) within the first month of advanced therapy initiation and another visit with each of the IBD dietician and the IBD GI psychologist 4+/- 2 weeks after first intervention visit.

active comparator: Group B - Diet Alone

Subjects will receive a visit with an IBD dietician (whether in person or virtual) within the first month of advanced therapy initiation and another visit with the IBD dietician 4+/-2 weeks after first intervention visit. They will be later offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes).

active comparator: Group C - Stress management alone

Subjects will receive a visit with an IBD GI psychologist (whether in person or virtual) within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after first intervention visit. They will be later offered a visit with an IBD dietician after 3 months (after assessment of our primary outcomes).

no intervention: Group D - Usual Care Arm

Subjects will be offered a visit with an IBD GI psychologist and IBD dietician (whether in person or virtual) after 3 months (after assessment of our outcomes).

Interventions

Diet Management

Visit with IBD dietician for diet management specifically for IBD

Stress Management

Visit with IBD GI psychologist for stress management

Primary outcome measure

  • Change marked by clinical remission of IBD [ Time Frame: 12 weeks, 24 weeks ]

Central Contacts and Locations

Central contacts

Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN

617-724-7559enolan4@mgb.org

Aarushi Gupta

agupta57@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN

617-724-7559enolan4@mgb.org

Aarushi Gupta

agupta57@mgh.harvard.edu

Principal Investigator:

Ashwin Ananthakrishnan, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-06.