Gestational Diabetes - PrEvention of PostPartum Diabetes Study

NCT05112588 | Recruiting

• 1 other identifier: VGFOUREG-969450
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Keywords

Prevention; Gestational diabetes; Physical activity; Randomized clinical trial; Primary Care; Digital support

Outcome Measures

Primary Outcomes (1)

• Diabetes mellitus type 2

  Number of women developing typ 2 diabetes

  Four years post partum

Secondary Outcomes (5)

• Insulin resistance

  4 years

• HbA1c

  Four years

• Fitness VO2max

  Four years

• Wellbeing

  Four years

• Glucose tolerance

  Four years

Study Arms (3)

Individual and digital support Intervention (IDSI)

EXPERIMENTAL

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).

Behavioral: Intervention

Care as usual

NO INTERVENTION

One arm including in women with gestational diabetes who will be subject to care as usual at the Health care unit.

Control

NO INTERVENTION

One arm with women with normal glucose tolerance as control. Will be examined carefully at the same time-point as women in the intervention.

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).

Individual and digital support Intervention (IDSI)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: This study concerns women with gestational diabetes
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational diabetes
• Signed "Informed consent"
• Will be expected to participate in ordinary child health care.
• Access to Internet via computer, pad or phone

You may not qualify if:

• Manifest diabetes mellitus before pregnancy.
• Other conditions, e.g. endocrine disorders, or treatment, e.g. cortisone medication, that could affect blood glucose control
• Suspicion of type 1 diabetes mellitus as assessed by GAD antibodies or clinical history
• Participation in other concomitant research study that could interfere with the study parameters
• Other disease, treatment or condition that according to the Principal Investigator precludes participation

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Maternity Ward, Västra Götaland

Skövde, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Margareta MI Hellgren

  Vastra Gotaland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margareta I Hellgren

CONTACT

+46708381612; margareta.leonardsson-hellgren@vgregion.se

Bledar P Daka

CONTACT

+46766186831; bledar.daka@gu.se

Study Design

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

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 9, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available from 6 months after publication at request and for ten years onwards.
• Access Criteria: Data will be provided by the PI of the study (Margareta Hellgren) after consideration of purpose of the use of the data. The use of the data must be ethical and in line with the purpose of the study

Locations

SE (1)