Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Mar 30:16:68.
doi: 10.1186/s12884-016-0851-x.

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

Maria Inês Schmidt  1   2 , Bruce B Duncan  3   4 , Cristina Castilhos  4 , Eliana Márcia Wendland  3   5 , Pedro C Hallal  6 , Beatriz D'Agord Schaan  4   7 , Michele Drehmer  3   4 , Adriana Costa E Forti  8   9 , Cristina Façanha  9   10 , Maria Angélica Nunes  3
Affiliations
Randomized Controlled Trial

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

Maria Inês Schmidt et al. BMC Pregnancy Childbirth. .

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.

Keywords: Gestational diabetes; Randomized controlled trial; Telemedicine; Type 2 diabetes mellitus; Weight loss.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Description of the study protocol, including major actions taken during each of its phases
See this image and copyright information in PMC

References

    1. World Health Organization . Preventing chronic diseases: a vital investment. 2005.
    1. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344(0028–4793 (Print)):1343–50. doi: 10.1056/NEJM200105033441801. - DOI - PubMed
    1. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393–403. doi: 10.1056/NEJMoa012512. - DOI - PMC - PubMed
    1. Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE, The Diabetes Prevention Program Research Group Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008;93:4774–9. doi: 10.1210/jc.2008-0772. - DOI - PMC - PubMed
    1. Aroda VR, Christophi CA, Edelstein SL, Zhang P, Herman WH, Barrett-Connor E, Delahanty LM, Montez MG, Ackermann RT, Zhuo X, Knowler WC, Ratner RE, for the Diabetes Prevention Program Research Group The Effect of Lifestyle Intervention and Metformin on Preventing or Delaying Diabetes Among Women With and Without Gestational Diabetes: The Diabetes Prevention Program Outcomes Study 10-Year Follow-Up. J Clin Endocrinol Metab. 2015;100:1646. doi: 10.1210/jc.2014-3761. - DOI - PMC - PubMed

Publication types

Associated data