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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

Overview of attention for article published in Trials, December 2014
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Title
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
Published in
Trials, December 2014
DOI 10.1186/1745-6215-15-513
Pubmed ID
Authors

Annsofie Adolfsson, Karolina Linden, Carina Sparud-Lundin, Per-Göran Larsson, Marie Berg

Abstract

Women with type 1 diabetes face particular demands in their lives in relation to childbearing. During pregnancy, in order to optimize the probability of giving birth to a healthy child, their blood glucose levels need to be as normal as possible. After childbirth, they experience a 'double stress': in addition to the ordinary challenges they face as new mothers, they also need to focus on getting their blood glucose levels normal. To improve self-management of diabetes and overall well-being in women with type 1 diabetes, a person-centered web-based support was designed to be tested in a randomized controlled trial (RCT) to be used during pregnancy and early motherhood. This protocol outlines the design of this RCT, which will evaluate the effectiveness of the specially designed web-based support for mothers with type 1 diabetes in Sweden.Methods/design: The study is designed as an RCT. The web support consists of three parts: 1) evidence-based information, 2) a self-care diary, and 3) communication with peers. The primary outcome is general well-being evaluated with the Well-Being Questionnaire short version (W-BQ12) and diabetes management evaluated with the Diabetes Empowerment Scale, short version (SWE-DES). Women attending six hospital-based antenatal care centers in Sweden are invited to participate. The inclusion period is November 2011 to late 2014. The allocation of participants to web support (intervention group) and to usual care (control group) is equal (1:1). In total, 68 participants in each group will be needed to reach a statistical power of 80% with significance level 0.05.

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Geographical breakdown

Country Count As %
Spain 2 <1%
South Africa 1 <1%
Unknown 317 99%

Demographic breakdown

Readers by professional status Count As %
Student > Master 58 18%
Student > Ph. D. Student 33 10%
Student > Bachelor 29 9%
Lecturer 26 8%
Researcher 17 5%
Other 56 18%
Unknown 101 32%
Readers by discipline Count As %
Nursing and Health Professions 67 21%
Medicine and Dentistry 55 17%
Psychology 23 7%
Social Sciences 20 6%
Engineering 5 2%
Other 35 11%
Unknown 115 36%