Clinical trial NCT01088152: Celiac Disease School for Women Living on a Gluten-free Diet
Official title: Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Education of Patients
Counseling
Problem-Based Learning
Keywords: Celiac disease
Education
Sweden
Gluten-free diet
Lead sponsor: Medical Research Council of Southeast Sweden
Sponsor class: OTHER_GOV
Collaborators: name: Linkoeping University
First posted: 2010-03-17
Enrollment: 106
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective health and well-being
timeFrame: 6 months
Secondary outcomes:
measure: Gastrointestinal symptoms and Psychological well-being
timeFrame: 6 months
Other outcomes:
Locations:
city: Norrkoping
country: Sweden
facility: Norrkoping Hospital,
Study officials:
affiliation: Norrkoping Hospitalö
name: Claes Hallert, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Hallert C, Sandlund O, Broqvist M. Perceptions of health-related quality of life of men and women living with coeliac disease. Scand J Caring Sci. 2003 Sep;17(3):301-7. doi: 10.1046/j.1471-6712.2003.00228.x.
citation: Sverker A, Hensing G, Hallert C. 'Controlled by food'- lived experiences of coeliac disease. J Hum Nutr Diet. 2005 Jun;18(3):171-80. doi: 10.1111/j.1365-277X.2005.00591.x.
citation: Midhagen G, Hallert C. High rate of gastrointestinal symptoms in celiac patients living on a gluten-free diet: controlled study. Am J Gastroenterol. 2003 Sep;98(9):2023-6. doi: 10.1111/j.1572-0241.2003.07632.x.
citation: Roos S, Karner A, Hallert C. Psychological well-being of adult coeliac patients treated for 10 years. Dig Liver Dis. 2006 Mar;38(3):177-80. doi: 10.1016/j.dld.2006.01.004. Epub 2006 Feb 7.