- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01565824
Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web) (MODIAB-web)
March 1, 2019 updated by: Göteborg University
The aim is to investigate whether the implementation of a web-based support to women with type 1 diabetes during pregnancy and early motherhood can improve well-being and self management of diabetes.
Type 1 diabetes is associated with increased medical risks and increased psychosocial pressure in relation to childbearing.
There is need for extended support from both health care professionals and peers.
Web-based interventions can improve personal capacity and self-management in people with long- term illnesses but are not evaluated in childbearing women with type 1 diabetes.
A web site prototype for full-size browsers and mobile devices has been developed through a participatory design by multidisciplinary researchers, health care professionals, experienced mothers with type 1 diabetes and web designers.
In a randomised control study the developed web site offering information, communication with health care professionals, person-centred self-care diaries and online social community of included women, is provided to the intervention group in early pregnancy at admission to specialised antenatal clinics at six hospitals in Sweden.
A control group will receive standard care (usual care).
Total n = 160.
Primary outcomes are Well-Being Questionnaire and Diabetes Empowerment Scale.
The intervention offers proactive solutions for strengthening patients' decision making of diabetes in daily life during pregnancy and early motherhood, and is expected to increase their wellbeing, personal capacity and knowledge of diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
174
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gothenburg, Sweden
- Sahlgrenska Academy, Institute of Health Care Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women with type 12 diabetes, included in early pregnancy (first trimester)
Exclusion Criteria:
- women who are illiterate, or do not read and speak Swedish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Usual care
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Experimental: Web-based support
The subjects will get access to a website where they can store blood glucose levels, read specialized information concerning pregnancy and early motherhood, and access a discussion forum for peer support.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diabetes Empowerment Scale (SWE-DES-10)
Time Frame: at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion
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at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion
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Well-Being Questionnaire (W-BQ12)
Time Frame: at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion
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at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
March 27, 2012
First Submitted That Met QC Criteria
March 28, 2012
First Posted (Estimate)
March 29, 2012
Study Record Updates
Last Update Posted (Actual)
March 4, 2019
Last Update Submitted That Met QC Criteria
March 1, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MODIAB-web
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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