IBD and Women's Health Wellness Program

NCT ID: NCT05172557

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-14

Study Completion Date

2023-12-26

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Living Program

In addition to usual clinical Inflammatory Bowel Disease medical care, subjects will participate in a Wellness Program.

Group Type EXPERIMENTAL

Wellness Program

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Wellness coaching sessions throughout 12 months of study participation

Interventions

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Wellness Program

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

Intervention Type BEHAVIORAL

Wellness Coaching

Wellness coaching sessions throughout 12 months of study participation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Laura E. Raffals, M.D

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Raffals, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-002100

Identifier Type: -

Identifier Source: org_study_id

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