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OpenTrials
Completed

NCT Number: NCT05172557

IBD and Women's Health Wellness Program

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wellness Program

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

Behavioral

Wellness coaching sessions throughout 12 months of study participation

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2021
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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