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OpenTrials
Completed

NCT Number: NCT01565824

Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web)

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska Academy, Institute of Health Care Sciences

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

web-based support

Other

Primary outcomes

  1. Diabetes Empowerment Scale (SWE-DES-10)

    Time frame: at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion

  2. Well-Being Questionnaire (W-BQ12)

    Time frame: at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Swedish Diabetes Association
  • Vastra Gotaland Region

Registry information

Acronym: MODIAB-web

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Mar 29, 2012
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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