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

NCT03767699 | Completed

• 2 other identifiers: 2013-12-239D43TW009135
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Weight Gain

Keywords

Medical nutrition therapy; Eating behavior; Type 2 diabetes mellitus; Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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).

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hugo Mendieta Zeron: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Instituto Nacional de Salud Publica, Mexico: collaborator

Study Sites (1)

Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, 50130, Mexico

Location

Related Publications (5)

• 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.

  PMID: 23492551 BACKGROUND

• 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.

  PMID: 19696205 BACKGROUND

• 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.

  PMID: 20815129 BACKGROUND

• 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.

  PMID: 23800568 BACKGROUND

• 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.

  PMID: 30880554 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain; Feeding Behavior; Diabetes Mellitus, Type 2; Diabetes, Gestational

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Adriana Garduño Alanís, PhD.

  Independent researcher.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of the Research Department

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 7, 2018
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

ME (1)