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.
abstract: BACKGROUND
  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
  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.
  
  
  CONCLUSIONS
  The web support is expected to strengthen the women's personal capacity and autonomy during pregnancy, breastfeeding, and early motherhood, leading to optimal well-being and diabetes management.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01565824 (registration date March 27th 2012).
authors.affiliation: School of Health and Medical Sciences, Örebro University, SE, 701 82, Örebro, Sweden. annsofie.adolfsson@oru.se.
authors.forename: Annsofie
authors.initials: A
authors.lastname: Adolfsson
authors.affiliation: Institutes of Health and Care Science, Sahlgrenska Academy, Gothenburg University, Box 457, SE, 405 30, Gothenburg, Sweden. karolina.linden@gu.se.|Centre for Person-Centred Care (GPCC), University of Gothenburg, Box 457, SE, 405 30, Gothenburg, Sweden. karolina.linden@gu.se.
authors.forename: Karolina
authors.initials: K
authors.lastname: Linden
authors.affiliation: Institutes of Health and Care Science, Sahlgrenska Academy, Gothenburg University, Box 457, SE, 405 30, Gothenburg, Sweden. carina.s-lundin@fhs.gu.se.|Centre for Person-Centred Care (GPCC), University of Gothenburg, Box 457, SE, 405 30, Gothenburg, Sweden. carina.s-lundin@fhs.gu.se.
authors.forename: Carina
authors.initials: C
authors.lastname: Sparud-Lundin
authors.affiliation: Department of Obstetrics and Gynecology, Skaraborg Hospital Skövde, SE, 541 85, Skövde, Sweden. p-g.larsson@vgregion.se.
authors.forename: Per-Göran
authors.initials: PG
authors.lastname: Larsson
authors.affiliation: Institutes of Health and Care Science, Sahlgrenska Academy, Gothenburg University, Box 457, SE, 405 30, Gothenburg, Sweden. marie.berg@fhs.gu.se.|Centre for Person-Centred Care (GPCC), University of Gothenburg, Box 457, SE, 405 30, Gothenburg, Sweden. marie.berg@fhs.gu.se.
authors.forename: Marie
authors.initials: M
authors.lastname: Berg
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002985:Clinical Protocols; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D005260:Female; D015438:Health Behavior; D063005:Health Information Systems; D007722:Health Knowledge, Attitudes, Practice; D006304:Health Status; D006801:Humans; D020407:Internet; D000068097:Maternal Health; D016487:Parenting; D010379:Peer Group; D026684:Personal Autonomy; D049590:Postpartum Period / Q000097:blood; D011247:Pregnancy; D011254:Pregnancy in Diabetics; D012107:Research Design; D012648:Self Care; D012657:Self-Help Groups; D061108:Social Media; D011795:Surveys and Questionnaires; D013548:Sweden; D013813:Therapy, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose