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Completed

NCT Number: NCT03767699

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medical Nutrition Therapy

Behavioral

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).

Primary outcomes

  1. Gestational Weight Gain

    Time frame: Nine months

    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.

Sponsors and collaborators

Lead sponsor

Hugo Mendieta Zeron

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • Instituto Nacional de Salud Publica, Mexico

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 7, 2018
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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