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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100383
• Other study ID #: 038/13
• Status: Completed
• Phase: N/A
• First received: March 29, 2017
• Last updated: March 29, 2017
• Start date: November 1, 2013
• Est. completion date: November 30, 2014

Study information

• Verified date: March 2017
• Source: Materno-Perinatal Hospital of the State of Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 30, 2014
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Body Weight
• Eating Behavior
• Weight Gain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Materno-Perinatal Hospital of the State of Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational Weight Gain (GWG).	GWG was calculated by subtracting the prepregnancy weight from the weight at the end of third trimester (kg).	9 months
Secondary	Eating behavior	The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18.	9 months