IBD and Women's Health Wellness Program

December 28, 2023 updated by: Laura E. Raffals, M.D, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Living Program
In addition to usual clinical Inflammatory Bowel Disease medical care, subjects will participate in a Wellness Program.
Behavioral: 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
Behavioral: Wellness Coaching
Wellness coaching sessions throughout 12 months of study participation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Wellness program on Quality of Life
Time Frame: 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.
Baseline day 1 to 12 months end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Laura Raffals, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2022

Primary Completion (Actual)

December 26, 2023

Study Completion (Actual)

December 26, 2023

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-002100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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