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

NCT ID: NCT03767699

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Gestational Weight Gain

Keywords

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Medical nutrition therapy Eating behavior Type 2 diabetes mellitus Gestational Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Instituto Nacional de Salud Publica, Mexico

OTHER

Sponsor Role collaborator

Hugo Mendieta Zeron

OTHER

Sponsor Role lead

Responsible Party

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Hugo Mendieta Zeron

Chief of the Research Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Adriana Garduño Alanís, PhD.

Role: STUDY_CHAIR

Independent researcher.

Locations

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Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, , Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 23492551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19696205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20815129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23800568 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30880554 (View on PubMed)

Other Identifiers

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D43TW009135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013-12-239

Identifier Type: -

Identifier Source: org_study_id