Glucose Levels and Outcomes in Women - Mid Pregnancy

NCT07598149 | Not Yet Recruiting

• 1 other identifier: SH-GLOW
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pregnancy

Keywords

pregnancy; blood sugar; stress; body image

Outcome Measures

Primary Outcomes (2)

• Continuous Blood Glucose via Dexcom G7

  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)

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• At least 18 years old
• Healthy single baby pregnancy
• to 28 weeks of pregnancy

You may not qualify if:

• history of diabetes
• history of gestational diabetes mellitus (GDM)
• history of cardiac disease
• history of endocrine disease
• assistive reproductive technology (IVF)

Sponsors & Collaborators

• Sanford Health: lead
• North Dakota State University: collaborator

Study Sites (3)

North Dakota State University

Fargo, North Dakota, 58102, United States

Location

Sanford Health

Fargo, North Dakota, 58104, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

Study Officials

• Anna M. Strahm, PhD

  Sanford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Biermann, MPH

CONTACT

605-312-6457; strahmlab@sanfordhealth.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)