Glucose Levels and Outcomes in Women - Mid Pregnancy (GLOW)
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Grace Biermann, MPH
- Telefonnummer: 605-312-6457
- E-mail: strahmlab@sanfordhealth.org
Studiesteder
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58104
- Sanford Health
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Kontakt:
- Grace Biermann, MPH
- Telefonnummer: 605-312-6457
- E-mail: grace.biermann@sanfordhealth.org
-
Ledende efterforsker:
- Anna M. Strahm, PhD
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Fargo, North Dakota, Forenede Stater, 58102
- North Dakota State University
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Kontakt:
- Grace Biermann, MPH
- Telefonnummer: 605-312-6457
- E-mail: grace.biermann@sanfordhealth.org
-
Underforsker:
- Clayton J. Hilmert, PhD
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57104
- Sanford Health
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Kontakt:
- Grace Biermann, MPH
- Telefonnummer: 605-312-6457
- E-mail: grace.biermann@sanfordhealth.org
-
Ledende efterforsker:
- Anna M. Strahm, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- At least 18 years old
- Healthy single baby pregnancy
- 14 to 28 weeks of pregnancy
Exclusion Criteria:
- history of diabetes
- history of gestational diabetes mellitus (GDM)
- history of cardiac disease
- history of endocrine disease
- assistive reproductive technology (IVF)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Continuous Blood Glucose via Dexcom G7
Tidsramme: 10 days
|
Participant will wear a Dexcom G7 CGM for 10 days to measure blood glucose levels (mg/dL)
|
10 days
|
|
Body Image in Pregnancy Scale (BIPS)
Tidsramme: 10 days
|
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). |
10 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Anna M. Strahm, PhD, Sanford Health
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- SH-GLOW
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Graviditet
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringCirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of PregnancyDet Forenede Kongerige