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

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

Sponsors

Lead Sponsor: Hugo Mendieta Zeron

Collaborator: John E. Fogarty International Center (FIC)
Instituto Nacional de Salud Publica, Mexico

Source Materno-Perinatal Hospital of the State of Mexico
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.

Overall Status Completed
Start Date November 2013
Completion Date November 2014
Primary Completion Date September 2014
Study Type Observational
Primary Outcome
Measure Time Frame
Gestational Weight Gain Nine months
Enrollment 57
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Medical Nutrition Therapy

Description: 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).

Eligibility

Sampling Method: Non-Probability Sample

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.

Gender: Female

Gender Based: Yes

Gender Description: Pregnant women

Minimum Age: 20 Years

Maximum Age: 40 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Adriana Garduño Alanís, PhD. Study Chair Independent researcher.
Location
Facility: Materno-Perinatal Hospital "Mónica Pretelini"
Location Countries

Mexico

Verification Date

December 2018

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Materno-Perinatal Hospital of the State of Mexico

Investigator Full Name: Hugo Mendieta Zeron

Investigator Title: Chief of the Research Department

Keywords
Has Expanded Access No
Condition Browse
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov