Glucose Levels and Outcomes in Women - Mid Pregnancy

ConditionPregnancy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSanford Health

About this trial

Up to 75% of reproductive age women are overweight, 40% are considered obese, and the prevalence of gestational diabetes mellitus (GDM) continues to rise, from 6% to 8.3% between 2016 and 2021. Currently understood GDM risk factors, such as advanced maternal age, prior history of GDM, family history of diabetes, and socioeconomic status can only explain up to 50% of cases. Related factors such as body image dissatisfaction, eating behaviors, and daily stress exposure have been linked to blood sugar metabolization, pregnancy outcomes, and the normative physiological changes that occur during pregnancy. These interrelated mechanisms may serve as additional risk factors that could help identify other women at risk of GDM. This project aims to investigate how body image dissatisfaction, eating behaviors, and daily stress exposure are associated with the metabolization of blood sugar during pregnancy.

In this study the Strahm Lab will recruit 50 pregnant women to participate in a study assessing blood sugar metabolization as it is related to stress, body image dissatisfaction, and eating behaviors. The study will use continuous glucose monitoring in concert with an ecological momentary assessment protocol to assess these interrelated factors over the course of 10 days between 14 and 28 weeks gestation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least 18 years old

Healthy single baby pregnancy

14 to 28 weeks of pregnancy

Disqualifiers

history of diabetes

history of gestational diabetes mellitus (GDM)

history of cardiac disease

history of endocrine disease

Trial population

The investigators will recruit 50 pregnant women prior to their 28th week of gestation from Sanford Health prenatal care providers in the Sioux Falls, SD, and Fargo, ND, areas.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Continuous Blood Glucose via Dexcom G7

Participant will wear a Dexcom G7 CGM for 10 days to measure blood glucose levels (mg/dL)

Time frame
10 days
2

Body Image in Pregnancy Scale (BIPS)

Participants will complete the full Body Image in Pregnancy Scale (BIPS) once prior to the start of the 10 day CGM/momentary assessment period and once at the end. The full BIPS scale is 36 items. It assesses body image dissatisfaction. Participants rate each item from one (strongly disagree) to five (strongly agree). Generally, lower scores indicate higher body satisfaction, while higher scores indicate higher levels of pregnancy-related body dissatisfaction/stress due to body image. Participants will receive 8 items from the scale to assess preoccupation with physical appearance and sexual attractiveness, prioritization of physical appearance over body functioning, appearance related behavioral avoidance, and dissatisfaction with body parts at least 5 times each day during the 10 day CGM/momentary assessment period. The full BIPS will be completed in REDCap. Momentary assessments will be completed via Real Time Assessment In the Natural Environment (ReTAINE).

Time frame
10 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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Sanford Health

Lead sponsor

North Dakota State University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: