Gestational Diabetes - PrEvention of PostPartum Diabetes Study

Sponsor
Vastra Gotaland Region
Study ID
NCT05112588
Status
Recruiting
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Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Intervention — BEHAVIORAL
    The women randomized to intervention will get support from the Child Health Care unit (CHCU) at every visit with the baby. Before the visit the women will have blood-samples taken and waist and weight measured. The women will also get support from a digital solution, specially developed for this purpose (MyMOWO). The nurse at the CHCU will include information and support to the mother at every visit accort´ding to a special protocol. All women will be carefully examined at baseline, after one and four years will blood-tests, anthropometric measurements and maximal oxygen uptake (VO2max).

Study Details

Gestational diabetes is the most common metabolic abnormality during pregnancy. In a Swedish population 2-10% of all pregnant women are diagnosed with gestational diabetes mellitus (GDM). The frequency differs dependent of methods for screening and diagnostic references, even within Sweden. Women with GDM have about 50% risk to develop manifest type 2 diabetes (T2DM) within 20 years. Most counties in Sweden have a recommendation to follow women with GDM yearly with an examination and an oral glucose tolerance test (OGTT). Unfortunately, this recommendation often fails, partly due to limited resources at the health care units but also due to lack of compliance from the women. Often after the baby is born focus is changed from the mother to the child and only 30.7% of the women with one or more risk factors performed an OGTT, despite stipulated OGTT in local guidelines. The diagnose GDM is under debate and Sweden has started to implement the recommendations from World Health Organisation (WHO) from 2013 with a lower cut-off for GDM, which will increase diagnostic sensitivity and consequently increase the number of women diagnosed with GDM. The plan was to conduct a randomized, clinical trial testing implementation the new recommendations in Sweden step-wise from 2018 and onwards. The recruitment is now complete and the results are expected to be published in 2021. The overarching aim of this study is to conduct a randomized, controlled clinical trial to test the effect of a model for a lifestyle intervention in clinical practice, using technical support as well as personal, individual support. The intervention is based on the existing organisation and structure in Primary Care and would thus be inexpensive and straight-forward to implement. An additive aim is to explore background mechanisms for the development of type 2 diabetes in women with gestational diabetes.

Key Dates

First listed
Nov 9, 2021
Start date
Nov 1, 2021
Status verified
Jun 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2030

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Individual and digital support Intervention (IDSI)
    The women randomized to intervention will get support from the Child Health Care unit (CHCU) at every visit with the baby. Before the visit the women will have blood-samples taken and waist and weight measured. The women will also get support from a digital solution, specially developed for this purpose (MyMOWO). The nurse at the CHCU will include information and support to the mother at every visit according to a special protocol. All women will be carefully examined at baseline, after one and four years will blood-tests, anthropometric measurements and maximal oxygen uptake (VO2max).
  • No Intervention: Care as usual
    One arm including in women with gestational diabetes who will be subject to care as usual at the Health care unit.
  • No Intervention: Control
    One arm with women with normal glucose tolerance as control. Will be examined carefully at the same time-point as women in the intervention.

Primary Outcome Measure

Diabetes mellitus type 2 [ Time Frame: Four years post partum ]

Central Contacts

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