title: Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02327286; Registered 23 December 2014.
authors.affiliation: Postgraduate Program in Epidemiology, School of Medicine, Federal University of Rio Grande do Sul, R. Ramiro Barcelos, 2600, Sala 414, Porto Alegre, RS, 90035-003, Brazil. maria.schmidt@ufrgs.br.|Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil. maria.schmidt@ufrgs.br.
authors.forename: Maria Inês
authors.initials: MI
authors.lastname: Schmidt
authors.affiliation: Postgraduate Program in Epidemiology, School of Medicine, Federal University of Rio Grande do Sul, R. Ramiro Barcelos, 2600, Sala 414, Porto Alegre, RS, 90035-003, Brazil.|Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Bruce B
authors.initials: BB
authors.lastname: Duncan
authors.affiliation: Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Cristina
authors.initials: C
authors.lastname: Castilhos
authors.affiliation: Postgraduate Program in Epidemiology, School of Medicine, Federal University of Rio Grande do Sul, R. Ramiro Barcelos, 2600, Sala 414, Porto Alegre, RS, 90035-003, Brazil.|Department of Collective Health, Federal University of Health Sciences, Porto Alegre, RS, Brazil.
authors.forename: Eliana Márcia
authors.initials: EM
authors.lastname: Wendland
authors.affiliation: Postgraduate Program in Epidemiology, Federal University of Pelotas, Pelotas, RS, Brazil.
authors.forename: Pedro C
authors.initials: PC
authors.lastname: Hallal
authors.affiliation: Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.|Postgraduate Studies Program in Endocrinology, School of Medicine, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.
authors.forename: Beatriz D'Agord
authors.initials: BD
authors.lastname: Schaan
authors.affiliation: Postgraduate Program in Epidemiology, School of Medicine, Federal University of Rio Grande do Sul, R. Ramiro Barcelos, 2600, Sala 414, Porto Alegre, RS, 90035-003, Brazil.|Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Michele
authors.initials: M
authors.lastname: Drehmer
authors.affiliation: Department of Internal Medicine, School of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.|Integrated Center for Diabetes and Hypertension, Ceará State Health Department, Fortaleza, Ceará, Brazil.
authors.forename: Adriana
authors.initials: A
authors.lastname: Costa E Forti
authors.affiliation: Integrated Center for Diabetes and Hypertension, Ceará State Health Department, Fortaleza, Ceará, Brazil.|School of Medicine, Centro Universitário Unichristus, Fortaleza, Ceará, Brazil.
authors.forename: Cristina
authors.initials: C
authors.lastname: Façanha
authors.affiliation: Postgraduate Program in Epidemiology, School of Medicine, Federal University of Rio Grande do Sul, R. Ramiro Barcelos, 2600, Sala 414, Porto Alegre, RS, 90035-003, Brazil.
authors.forename: Maria Angélica
authors.initials: MA
authors.lastname: Nunes
mesh_terms: D000328:Adult; D001938:Brazil; D003924:Diabetes Mellitus, Type 2 / Q000209:etiology / Q000517:prevention & control*; D016640:Diabetes, Gestational / Q000473:pathology; D005260:Female; D006801:Humans; D008019:Life Style; D049590:Postpartum Period; D011247:Pregnancy; D015397:Program Evaluation / Q000379:methods*; D012107:Research Design; D012307:Risk Factors; D055815:Young Adult
keywords: Gestational diabetes; Randomized controlled trial; Telemedicine; Type 2 diabetes mellitus; Weight loss