Weight Changes During and After Pregnancy in Women With Gestational Diabetes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02388958

Enrollment

Registered

2015-03-17

Start date

2014-06-30

Completion date

2016-12-31

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

Brief summary

Gestational diabetes mellitus (GDM) is associated with short-term and long-term complications for infants and mothers. The management of GDM during pregnancy focuses on reducing risks to the infant associated with hyperglycemia. The postpartum management of GDM focuses on reducing maternal risk of developing type 2 diabetes (T2DM). A diagnosis of GDM identifies up to 31% of parous women who will eventually develop T2DM and approximately 50% of women diagnosed with GDM will develop T2DM in the first 5 years postpartum. The perceived risk of developing short-term and/or long-term complications of GDM may influence women's likelihood of engaging in diet modification, the mainstay of treatment of GDM, both during and after pregnancy. If sustained after delivery, diet modifications introduced as treatment for GDM could affect maternal weight changes during and after pregnancy, which could in turn affect T2DM risk. It is unknown if and how women with GDM differ in their perceived risk of developing T2DM, dietary choices, or weight gain (and retention) during versus after pregnancy. Therefore, the project proposed in this application seeks to (1) characterize the perceived risk of developing T2DM among women with GDM during and after pregnancy, (2) characterize dietary choices of women with GDM during and after pregnancy, and (3) characterize weight changes of women with GDM during and after pregnancy as compared to women without GDM.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

for women with GDM: * Patient is currently pregnant with a singleton pregnancy. * Laboratory confirmed diagnosis of GDM between weeks 24-28 gestation. * Patient is receiving routine prenatal care at Vanderbilt University Medical Center. Inclusion Criteria for women without GDM: * Patient is currently pregnant with a singleton pregnancy. * Patient does not have GDM based on non-fasting and/or fasting GTT results. * Patient is receiving routine prenatal care at Vanderbilt University Medical Center.

Exclusion criteria

for both cohorts: * Diagnosis of type 1 or type 2 diabetes prior to pregnancy. * Diagnosis of GDM prior to 20 weeks gestation. * Patient does not speak English.

Design outcomes

Primary

Measure	Time frame
Postpartum weight change measured in kilograms	6 months (change in weight from the time of delivery to 6 months postpartum)

Secondary

Measure	Time frame
Rate of pregnancy weight gain prior to GDM diagnosis measured in kilograms per week	24-28 weeks
Rate of pregnancy weight gain after GDM diagnosis measured in kilograms per week	10-16 weeks
Change in perceived risk of developing diabetes during versus after pregnancy measured with the Risk Perception Survey for Developing Diabetes (RPS-DD)	10 months
Change in dietary choices during versus after pregnancy measured with the Personal Diabetes Questionnaire	10 months

Countries

United States

Outcome results