NCT03767699|Completed
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Sponsor study identifier
Secondary identifiers
NIH
observational
57
1 country
1
Study Start
November 2013
Actual (reported)Primary Completion
September 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes Mellitus (GDM) create complications during pregnancy, particularly in women with gestational weight gain (GWG) that falls over the recommended limit. On the other hand Medical nutrition therapy (MNT) has been shown to reduce some complications in women with T2DM and GDM. The aim of this project was to assess the association of MNT consultations and eating behavior with GWG in Mexican women with T2DM and GDM.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2013
Actual (reported)September 2014
Actual (reported)November 2014
Actual (reported)December 4, 2018
Actual (reported)December 7, 2018
Actual (reported)Gestational Weight Gain
Weight (kg) was measured using a weight scale (SECA 711). GWG was calculated by subtracting the prepregnancy weight from the weight at the end of the third trimester (kg). Recommended GWG was based on U.S. Institute of Medicine guidelines.
Nine months
MNT was offered every 2-4 weeks to all pregnant women with T2DM and GDM. Women. MNT is offered as a mandatory part of their prenatal visit and/or hospital stay. The MNT provides an individual food plan with the following recommendations: total calories should be calculated as 30 kcal/kg based on pregestational BMI for an ideal weight. Of the total energy intake 40-45% is provided by carbohydrates, a maximum of 40% is provided by lipids and the remaining percentage by proteins providing moderate-to-low glycemic index foods and fiber consumption, glucose self-monitoring, participating in 15-30 min of daily physical activity after prior authorization of the treating physician, and meeting the minimal energy requirements of pregnancy (never \< 1,500 kcal).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pregnant women with T2DM or GDM who received as a routine management the Medical Nutrition Therapy. The characteristics of the pregnant women usually attended at the Maternal-Perinatal Hospital "Mónica Pretelini Sáenz" are: low socioecomic status and education, they all receive free medical attention.
Materno-Perinatal Hospital "Mónica Pretelini"
Toluca, 50130, Mexico
Horosz E, Bomba-Opon DA, Szymanska M, Wielgos M. Maternal weight gain in women with gestational diabetes mellitus. J Perinat Med. 2013 Sep 1;41(5):523-8. doi: 10.1515/jpm-2012-0254.
Perichart-Perera O, Balas-Nakash M, Parra-Covarrubias A, Rodriguez-Cano A, Ramirez-Torres A, Ortega-Gonzalez C, Vadillo-Ortega F. A medical nutrition therapy program improves perinatal outcomes in Mexican pregnant women with gestational diabetes and type 2 diabetes mellitus. Diabetes Educ. 2009 Nov-Dec;35(6):1004-13. doi: 10.1177/0145721709343125. Epub 2009 Aug 20.
Adriana Garduño Alanís, PhD.
Independent researcher.
57 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2018
First Posted
December 7, 2018
Study Start
November 2013
Actual (reported)Management of Gestational Weight Gain by Family Physicians: Seeking Congruence With Guidelines
Contact the study team to confirm eligibility.
Balas-Nakash M, Rodriguez-Cano A, Munoz-Manrique C, Vasquez-Pena P, Perichart-Perera O. [Adherence to a medical nutrition therapy program in pregnant women with diabetes, measured by three methods, and its association with glycemic control]. Rev Invest Clin. 2010 May-Jun;62(3):235-43. Spanish.
Jaakkola J, Hakala P, Isolauri E, Poussa T, Laitinen K. Eating behavior influences diet, weight, and central obesity in women after pregnancy. Nutrition. 2013 Oct;29(10):1209-13. doi: 10.1016/j.nut.2013.03.008. Epub 2013 Jun 22.
Garduno-Alanis A, Torres-Mejia G, Nava-Diaz P, Herrera-Villalobos J, Diaz-Arizmendi D, Mendieta-Zeron H. Association between a medical nutrition therapy program and eating behavior with gestational weight gain in women with diabetes. J Matern Fetal Neonatal Med. 2020 Dec;33(24):4049-4054. doi: 10.1080/14767058.2019.1594764. Epub 2019 Mar 28.
Primary Completion
September 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
December 7, 2018
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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