Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web) (MODIAB-web)
Primary Purpose
Diabetes Type 1, Pregnancy, Early Motherhood
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
web-based support
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Type 1
Eligibility Criteria
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
Sites / Locations
- Sahlgrenska Academy, Institute of Health Care Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Web-based support
Usual care
Arm Description
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.
Outcomes
Primary Outcome Measures
Diabetes Empowerment Scale (SWE-DES-10)
Well-Being Questionnaire (W-BQ12)
Secondary Outcome Measures
Full Information
NCT ID
NCT01565824
First Posted
March 27, 2012
Last Updated
March 1, 2019
Sponsor
Göteborg University
Collaborators
Swedish Diabetes Association, Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT01565824
Brief Title
Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)
Acronym
MODIAB-web
Official Title
Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Swedish Diabetes Association, Vastra Gotaland Region
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 1, Pregnancy, Early Motherhood
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-based support
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
web-based support
Primary Outcome Measure Information:
Title
Diabetes Empowerment Scale (SWE-DES-10)
Time Frame
at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion
Title
Well-Being Questionnaire (W-BQ12)
Time Frame
at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sahlgrenska Academy, Institute of Health Care Sciences
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
25543854
Citation
Adolfsson A, Linden K, Sparud-Lundin C, Larsson PG, Berg M. A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial. Trials. 2014 Dec 29;15:513. doi: 10.1186/1745-6215-15-513.
Results Reference
derived
Learn more about this trial
Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)
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