Celiac Disease School for Women Living on a Gluten-free Diet

Not Applicable

• Conditions: Education of Patients; Counseling; Problem-Based Learning
• Interventions: Behavioral: Usual care of celiac disease women; Behavioral: Celiac school

• Registration Number: NCT01088152
• Lead Sponsor: Medical Research Council of Southeast Sweden

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 Timeline

• Status Verified: 2001-01
• Study Start: 2008-08
• Primary Completion: 2009-01
• Study Completion: 2010-03
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Last Update Submitted: 2010-03-16
• Study First Posted: 2010-03-17
• Last Update Posted: 2010-03-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care of celiac disease women	Usual care of celiac disease women	Written information corresponding to that offered when seeking medical advice for celiac disease in primary care
Celiac School	Celiac school	Structured education using problem-based learning at 10 sessions

Primary Outcome Measures

Name	Time	Method
Subjective health and well-being	6 months	Gastrointestinal symptoms and Psychological well-being

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms and Psychological well-being	6 months	Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale.

Trial Locations

Locations (1)

Norrkoping Hospital,; 🇸🇪 Norrkoping, Sweden