IBD and Women's Health Wellness Program

NCT05172557 | Completed

• 1 other identifier: 21-002100
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Impact of Wellness program on Quality of Life

  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

Study Arms (1)

Healthy Living Program

EXPERIMENTAL

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

Behavioral: Wellness Program; Behavioral: Wellness Coaching

Interventions

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

Healthy Living Program

Wellness Coaching BEHAVIORAL

Wellness coaching sessions throughout 12 months of study participation

Healthy Living Program

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Laura Raffals, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: December 29, 2021
• Study Start: April 14, 2022
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)