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

Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01088152
Acronym
CDST
Enrollment
106
Registered
2010-03-17
Start date
2008-08-31
Completion date
2010-03-31
Last updated
2010-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Counseling, Education of Patients, Problem-Based Learning

Keywords

Celiac disease, Education, Sweden, Gluten-free diet

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.

Interventions

BEHAVIORALCeliac school

Structured education of adult celiac patients at 10 sessions.

BEHAVIORALUsual care of celiac disease women

Written information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care.

Sponsors

Linkoeping University
CollaboratorOTHER_GOV
Medical Research Council of Southeast Sweden
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Subjective health and well-being6 monthsGastrointestinal symptoms and Psychological well-being

Secondary

MeasureTime frameDescription
Gastrointestinal symptoms and Psychological well-being6 monthsTwo questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale.

Countries

Sweden

Contacts

Primary ContactLisa Jacobsson, MSc RN
lisa.ring.jacobsson@isv.liu.se+4611363595
Backup ContactClaes Hallert, MD,PhD
Claes.Hallert@lio.se+46 70543 8282

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026