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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.

Adolfsson A, Linden K, Sparud-Lundin C, Larsson PG, Berg M - Trials (2014)

Bottom Line: 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.The inclusion period is November 2011 to late 2014.In total, 68 participants in each group will be needed to reach a statistical power of 80% with significance level 0.05.

View Article: PubMed Central - PubMed

Affiliation: School of Health and Medical Sciences, Örebro University, SE, 701 82, Örebro, Sweden. annsofie.adolfsson@oru.se.

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/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.

Discussion: 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.

Trial registration: ClinicalTrials.gov: NCT01565824 (registration date March 27th 2012).

No MeSH data available.


Related in: MedlinePlus

Flow diagram MODIAB-Web evaluating a web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden: study protocol for a randomized controlled trial.
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Fig1: Flow diagram MODIAB-Web evaluating a web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden: study protocol for a randomized controlled trial.

Mentions: The study is labeled MODIAB-Web and is designed as an RCT to evaluate the effect of a web-based support system on well-being and diabetes management in the study group. An equal number of study participants, pregnant women with type 1 diabetes, will be included in the intervention group and control group (1:1). Web-based support will be offered to the intervention group as a complement to the usual diabetes and pregnancy care. Women allocated to the control group will receive the usual care. The study design is in accordance with the CONSORT recommendation for reporting pragmatic randomized controlled trials [14]. The flow of the RCT is illustrated in Figure 1.Figure 1


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.

Adolfsson A, Linden K, Sparud-Lundin C, Larsson PG, Berg M - Trials (2014)

Flow diagram MODIAB-Web evaluating a web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden: study protocol for a randomized controlled trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4414296&req=5

Fig1: Flow diagram MODIAB-Web evaluating a web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden: study protocol for a randomized controlled trial.
Mentions: The study is labeled MODIAB-Web and is designed as an RCT to evaluate the effect of a web-based support system on well-being and diabetes management in the study group. An equal number of study participants, pregnant women with type 1 diabetes, will be included in the intervention group and control group (1:1). Web-based support will be offered to the intervention group as a complement to the usual diabetes and pregnancy care. Women allocated to the control group will receive the usual care. The study design is in accordance with the CONSORT recommendation for reporting pragmatic randomized controlled trials [14]. The flow of the RCT is illustrated in Figure 1.Figure 1

Bottom Line: 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.The inclusion period is November 2011 to late 2014.In total, 68 participants in each group will be needed to reach a statistical power of 80% with significance level 0.05.

View Article: PubMed Central - PubMed

Affiliation: School of Health and Medical Sciences, Örebro University, SE, 701 82, Örebro, Sweden. annsofie.adolfsson@oru.se.

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/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.

Discussion: 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.

Trial registration: ClinicalTrials.gov: NCT01565824 (registration date March 27th 2012).

No MeSH data available.


Related in: MedlinePlus