Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain

Gestational Weight Gain Clinical Trial

Official title:

Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain in Mexican Women With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767699
• Other study ID #: 2013-12-239
• Secondary ID: D43TW009135
• Status: Completed
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2018
• Source: Materno-Perinatal Hospital of the State of Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Weight Gain

Intervention

Behavioral:
• Medical Nutrition Therapy
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).

Locations

Country	Name	City	State
Mexico	Materno-Perinatal Hospital "Mónica Pretelini"	Toluca

Sponsors (3)

Lead Sponsor	Collaborator
Hugo Mendieta Zeron	Instituto Nacional de Salud Publica, Mexico, John E. Fogarty International Center (FIC)

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Balas-Nakash M, Rodríguez-Cano A, Muñoz-Manrique C, Vásquez-Peña 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. — View 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. — View 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. — View Citation

Perichart-Perera O, Balas-Nakash M, Parra-Covarrubias A, Rodriguez-Cano A, Ramirez-Torres A, Ortega-González 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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