- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07598149
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Grace Biermann, MPH
- Phone Number: 605-312-6457
- Email: strahmlab@sanfordhealth.org
Study Locations
-
-
North Dakota
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Fargo, North Dakota, United States, 58104
- Sanford Health
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Contact:
- Grace Biermann, MPH
- Phone Number: 605-312-6457
- Email: grace.biermann@sanfordhealth.org
-
Principal Investigator:
- Anna M. Strahm, PhD
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Fargo, North Dakota, United States, 58102
- North Dakota State University
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Contact:
- Grace Biermann, MPH
- Phone Number: 605-312-6457
- Email: grace.biermann@sanfordhealth.org
-
Sub-Investigator:
- Clayton J. Hilmert, PhD
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- Sanford Health
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Contact:
- Grace Biermann, MPH
- Phone Number: 605-312-6457
- Email: grace.biermann@sanfordhealth.org
-
Principal Investigator:
- Anna M. Strahm, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Continuous Blood Glucose via Dexcom G7
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna M. Strahm, PhD, Sanford Health
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SH-GLOW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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