IBD and Women's Health Wellness Program

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease
• Interventions: Behavioral: Wellness Program; Behavioral: Wellness Coaching

• Registration Number: NCT05172557
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-29
• Study Start: 2022-04-14
• Status Verified: 2023-12
• Primary Completion: 2023-12-26
• Study Completion: 2023-12-26
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Living Program	Wellness Program	In addition to usual clinical Inflammatory Bowel Disease medical care, subjects will participate in a Wellness Program.
Healthy Living Program	Wellness Coaching	In addition to usual clinical Inflammatory Bowel Disease medical care, subjects will participate in a Wellness Program.

Primary Outcome Measures

Name	Time	Method
Impact of Wellness program on Quality of Life	Baseline day 1 to 12 months end of study	Health 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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States