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

NCT01565824 | Completed DMC

• 1 other identifier: MODIAB-web
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 1; Pregnancy; Early Motherhood

Outcome Measures

Primary Outcomes (2)

• Diabetes Empowerment Scale (SWE-DES-10)

  at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion

• Well-Being Questionnaire (W-BQ12)

  at inclusion, 7 months after inclusion, 10 months after inclusion, 14 months after inclusion

Study Arms (2)

Web-based support

EXPERIMENTAL

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.

Other: web-based support

Usual care

NO INTERVENTION

Interventions

web-based support OTHER

Web-based support

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with type 12 diabetes, included in early pregnancy (first trimester)

You may not qualify if:

• women who are illiterate, or do not read and speak Swedish

Sponsors & Collaborators

• Göteborg University: lead
• Swedish Diabetes Association: collaborator
• Vastra Gotaland Region: collaborator

Study Sites (1)

Sahlgrenska Academy, Institute of Health Care Sciences

Gothenburg, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25543854 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 4, 2019

Record last verified: 2019-03

Locations

SE (1)