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IBD and Women's Health Wellness Program

Evaluating the Need and Impact of a Multifaceted Wellness Program on the Health Related Quality of Life (HRQOL), Disease Activity, and Healthcare Utilization in Female Patients With Inflammatory Bowel Disease: Phase II - The Impact

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05172557
Enrollment
50
Registered
2021-12-29
Start date
2022-04-14
Completion date
2023-12-26
Last updated
2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease

Brief summary

Researchers want to understand if a combination of usual medical care along with a wellness program designed for women with Inflammatory Bowel Disease diagnosis will have an effect on quality of life, stress, and disease activity.

Detailed description

It will take a year to complete the study and involves subjects participating in a Wellness program, wellness coaching and completion of surveys. Subjects will be requested to complete wellness classes along with one wellness coaching session within the first two months of study participation, and continue their year long participation of wellness coaching sessions and surveys.

Interventions

Wellness Program involves participation in classes with topics involving resiliency, stress, physical activity, and nutrition to be completed within a few months of study participation

Wellness coaching sessions throughout 12 months of study participation

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Female patient with a diagnosis of Ulcerative Colitis or Crohn's Disease seen in the Inflammatory Bowel Disease clinic in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester. * Who are between 18-64 years of age. * Ability to provide informed consent. * Ability to complete all aspects of this trial.

Exclusion criteria

* Female patients with a diagnosis of Ulcerative Colitis or Crohn's Disease with medical co-morbidity or factor judged by the investigator to preclude participation in the study or which might hinder adherence. * Participation in another organized wellness program.

Design outcomes

Primary

MeasureTime frameDescription
Impact of Wellness program on Quality of LifeBaseline day 1 to 12 months end of studyHealth Related Quality of life over the study will be determined by changes through subject completion of the Short Form 12 scoring from 0 to 100, with higher scores indicating better physical and mental health functioning.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026