Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain

March 29, 2017 updated by: Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico

Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain in Women With Diabetes

To assess the association of the number of medical nutrition therapy (MNT) consultations and eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM).

Study Overview

Status

Completed

Detailed Description

Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study. Gestational diabetes was diagnosed with a 75-g oral glucose tolerance test. Weight (kg) and height (m) were measured using a mechanical column scale (SECA).

The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18 (TFEQ-18).

The Medical Nutrition Therapy (MNT) was offered every 2-4 weeks. This therapy consists of providing a food plan with the following recommendations: limiting carbohydrate intake to 35-45% of total calories calculated as 30 kcal/kg based on pregestational BMI for an ideal weight .

We evaluated the effect of MNT on GWG using a multiple linear regression model

Study Type

Observational

Enrollment (Actual)

57

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study.

Description

Inclusion Criteria:

  • Women in puerperium with known T2DM or GDM diagnosed at the hospital.

Exclusion Criteria:

  • Women with a twin or other multiple pregnancy, type 1 diabetes mellitus (T1DM), or intolerance to carbohydrates, and those with additional diseases (hypertensive disorders of pregnancy, hyper- or hypothyroidism, lupus, kidney or liver disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational Weight Gain (GWG).
Time Frame: 9 months
GWG was calculated by subtracting the prepregnancy weight from the weight at the end of third trimester (kg).
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating behavior
Time Frame: 9 months
The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

November 30, 2014

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 038/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Weight Gain

3
Subscribe