NCT03100383

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

March 29, 2017

Last Update Submit

March 29, 2017

Conditions

Weight GainEating Behavior

Keywords

gestational diabetesType2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Eating behavior

    9 months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight GainFeeding BehaviorDiabetes, Gestational

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehaviorPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hugo Mendieta Zerón, PhD.

    Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Research Department

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

November 30, 2014

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share