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Open Access 01-12-2016 | Study protocol

Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial

Authors: Maria Inês Schmidt, Bruce B. Duncan, Cristina Castilhos, Eliana Márcia Wendland, Pedro C. Hallal, Beatriz D’Agord Schaan, Michele Drehmer, Adriana Costa e Forti, Cristina Façanha, Maria Angélica Nunes

Published in: BMC Pregnancy and Childbirth | Issue 1/2016

Abstract

Background

Gestational diabetes mellitus (GDM), a hyperglycemic state detected during pregnancy, is an established risk factor for diabetes. However, treatment during pregnancy in and of itself is not able to eliminate this risk, and a considerable fraction of women with GDM will develop frank diabetes in the decade following pregnancy. Our aim is to conduct a multicenter randomized controlled trial to investigate the effectiveness of a lifestyle intervention program implemented after a pregnancy complicated by GDM in delaying or preventing the development of type 2 diabetes.

Methods

Women aged 18 or older identified as having recent GDM are recruited and followed by telephone to assess eligibility for the trial. To be eligible, women must have used insulin during pregnancy or present intermediate hyperglycemia postpartum. Women are encouraged to enter the trial as early as 10 weeks, and are permitted to do so up to 2 years after a pregnancy with GDM. An estimated 740 women will be randomized to either conventional care or to coach-based interventions focused on breastfeeding, weight loss, healthy eating, and increased physical activity, and predominantly delivered by telephone. Women are followed annually to detect new onset diabetes, the primary outcome, and additional secondary outcomes which include reversion to normoglycemia, weight loss, physical activity and fitness, and insulin resistance.

Discussion

Though previous studies have demonstrated that type 2 diabetes can be delayed or prevented, no study has yet demonstrated the feasibility and effectiveness of similar interventions implemented in the postpartum period for women with recent GDM. If shown to be successful, this approach could become an important means of preventing diabetes in primary care settings.

Trial registration

ClinicalTrials.gov Identifier: NCT02327286; Registered 23 December 2014.

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Title: Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial
Authors: Maria Inês Schmidt
Bruce B. Duncan
Cristina Castilhos
Eliana Márcia Wendland
Pedro C. Hallal
Beatriz D’Agord Schaan
Michele Drehmer
Adriana Costa e Forti
Cristina Façanha
Maria Angélica Nunes
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: BMC Pregnancy and Childbirth / Issue 1/2016
Electronic ISSN: 1471-2393
DOI: https://doi.org/10.1186/s12884-016-0851-x

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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