Cargando…

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

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 diab...

Descripción completa

Detalles Bibliográficos
Autores principales: Schmidt, Maria Inês, Duncan, Bruce B., Castilhos, Cristina, Wendland, Eliana Márcia, Hallal, Pedro C., Schaan, Beatriz D’Agord, Drehmer, Michele, Costa e Forti, Adriana, Façanha, Cristina, Nunes, Maria Angélica
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4812654/
https://www.ncbi.nlm.nih.gov/pubmed/27029489
http://dx.doi.org/10.1186/s12884-016-0851-x
_version_ 1782424210504679424
author Schmidt, Maria Inês
Duncan, Bruce B.
Castilhos, Cristina
Wendland, Eliana Márcia
Hallal, Pedro C.
Schaan, Beatriz D’Agord
Drehmer, Michele
Costa e Forti, Adriana
Façanha, Cristina
Nunes, Maria Angélica
author_facet Schmidt, Maria Inês
Duncan, Bruce B.
Castilhos, Cristina
Wendland, Eliana Márcia
Hallal, Pedro C.
Schaan, Beatriz D’Agord
Drehmer, Michele
Costa e Forti, Adriana
Façanha, Cristina
Nunes, Maria Angélica
author_sort Schmidt, Maria Inês
collection PubMed
description 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.
format Online
Article
Text
id pubmed-4812654
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-48126542016-03-31 Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial Schmidt, Maria Inês Duncan, Bruce B. Castilhos, Cristina Wendland, Eliana Márcia Hallal, Pedro C. Schaan, Beatriz D’Agord Drehmer, Michele Costa e Forti, Adriana Façanha, Cristina Nunes, Maria Angélica BMC Pregnancy Childbirth Study Protocol 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. BioMed Central 2016-03-30 /pmc/articles/PMC4812654/ /pubmed/27029489 http://dx.doi.org/10.1186/s12884-016-0851-x Text en © Schmidt et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Schmidt, Maria Inês
Duncan, Bruce B.
Castilhos, Cristina
Wendland, Eliana Márcia
Hallal, Pedro C.
Schaan, Beatriz D’Agord
Drehmer, Michele
Costa e Forti, Adriana
Façanha, Cristina
Nunes, Maria Angélica
Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial
title Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial
title_full Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial
title_fullStr Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial
title_full_unstemmed Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial
title_short Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial
title_sort lifestyle intervention for diabetes prevention after pregnancy (linda-brasil): study protocol for a multicenter randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4812654/
https://www.ncbi.nlm.nih.gov/pubmed/27029489
http://dx.doi.org/10.1186/s12884-016-0851-x
work_keys_str_mv AT schmidtmariaines lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial
AT duncanbruceb lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial
AT castilhoscristina lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial
AT wendlandelianamarcia lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial
AT hallalpedroc lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial
AT schaanbeatrizdagord lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial
AT drehmermichele lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial
AT costaefortiadriana lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial
AT facanhacristina lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial
AT nunesmariaangelica lifestyleinterventionfordiabetespreventionafterpregnancylindabrasilstudyprotocolforamulticenterrandomizedcontrolledtrial