Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Subjective health and well-being
Study Overview
Brief Summary
Swedish celiac disease women living on a gluten-free diet for years report poorer subjective health and more bowel complaints than Swedish women of same age in general population.
The investigators hypothesis is that the women participating in an education programme based on problem based learning will show higher degree of perceived health than the women receiving usual care.
Detailed Description
Celiac disease is a disorder of the small intestines triggered by dietary gluten, a protein in wheat-containing foods. Living with is far from easy and associated with restrictions and various dilemmas in daily life, leading to depressed mood and reduced well-being, particularly in women. We decided to include 100 celiac disease women on a gluten-free diet into a randomized controlled education trial in order to compare problem-based learning with usual care. Outcome measures will be two frequently employed questionnaires: PGWB (Psychological Well-being Index) to monitor Well-being and GSRS (Gastrointestinal Symptom Rating Scale) to measure the rate bowel symptoms as assessed at 6 months after the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged 20 yrs or above with Celiac disease treated for at least five years
Exclusion Criteria
- •Anticipated inability to comply the trial protocol
Outcomes
Primary Outcomes
Subjective health and well-being
Time Frame: 6 months
Gastrointestinal symptoms and Psychological well-being
Secondary Outcomes
- Gastrointestinal symptoms and Psychological well-being(6 months)