Clinical trial NCT03767699: Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain
Official title: Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain in Mexican Women With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Weight Gain
Keywords: Medical nutrition therapy
Eating behavior
Type 2 diabetes mellitus
Gestational Diabetes
Lead sponsor: Materno-Perinatal Hospital of the State of Mexico
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: Instituto Nacional de Salud Publica, Mexico
First posted: 2018-12-07
Enrollment: 57
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: This cross-sectional study conducted at from 2013 to 2014. Fifty seven patients with T2DM or GDM were invited to participate. The dependent variable was GWG and the main independent variables were MNT and eating behaviors. Data were obtained from medical records or interviews. Multiple linear regression models were used to assess associations.

Eligibility criteria: Inclusion Criteria:

* Women who had given birth and with known T2DM.
* Women who had given birth and with GDM diagnosed during pregnancy.

Exclusion Criteria:

* Women with multiple pregnancies.
* Women with type 1 diabetes mellitus.
* Women with glucose intolerance.
* Women with chronic diseases.

Primary outcomes:
measure: Gestational Weight Gain
timeFrame: Nine months
Secondary outcomes:
Other outcomes:
Locations:
city: Toluca
country: Mexico
facility: Materno-Perinatal Hospital "Mónica Pretelini"
Study officials:
affiliation: Independent researcher.
name: Adriana Garduño Alanís, PhD.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.