[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07598149":3,"trial-entities:NCT07598149":100,"trial-summary:NCT07598149":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":18,"study_type":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":37,"sex":38,"minimum_age":39,"maximum_age":15,"healthy_volunteers":40,"eligibility_criteria":41,"std_ages":53,"locations":56,"central_contacts":93,"overall_officials":96,"references":98,"see_also_links":99},"NCT07598149","SH-GLOW","Glucose Levels and Outcomes in Women - Mid Pregnancy","NOT_YET_RECRUITING","2028-05","2026-05","2026-05-20","Sanford Health","OTHER",false,"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.\n\nIn 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.",null,[17],"Pregnancy",[19,20,21,22],"pregnancy","blood sugar","stress","body image","OBSERVATIONAL",[],{"count":26,"type":27},50,"ESTIMATED",[],[30,34],{"measure":31,"description":32,"timeFrame":33},"Continuous Blood Glucose via Dexcom G7","Participant will wear a Dexcom G7 CGM for 10 days to measure blood glucose levels (mg\u002FdL)","10 days",{"measure":35,"description":36,"timeFrame":33},"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\u002Fmomentary 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\u002Fstress due to body image.\n\nParticipants 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\u002Fmomentary assessment period. The full BIPS will be completed in REDCap. Momentary assessments will be completed via Real Time Assessment In the Natural Environment (ReTAINE).",[],"FEMALE","18 Years",true,{"inclusion":42,"exclusion":46,"raw_text":52},[43,44,45],"At least 18 years old","Healthy single baby pregnancy","14 to 28 weeks of pregnancy",[47,48,49,50,51],"history of diabetes","history of gestational diabetes mellitus (GDM)","history of cardiac disease","history of endocrine disease","assistive reproductive technology (IVF)","Inclusion Criteria:\n\n* At least 18 years old\n* Healthy single baby pregnancy\n* 14 to 28 weeks of pregnancy\n\nExclusion Criteria:\n\n* history of diabetes\n* history of gestational diabetes mellitus (GDM)\n* history of cardiac disease\n* history of endocrine disease\n* assistive reproductive technology (IVF)",[54,55],"ADULT","OLDER_ADULT",[57,75,83],{"facility":58,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":72},"North Dakota State University","Fargo","North Dakota","58102","United States",[64,69],{"name":65,"role":66,"phone":67,"email":68},"Grace Biermann, MPH","CONTACT","605-312-6457","grace.biermann@sanfordhealth.org",{"name":70,"role":71},"Clayton J. Hilmert, PhD","SUB_INVESTIGATOR",{"lat":73,"lon":74},46.87719,-96.7898,{"facility":11,"city":59,"state":60,"zip":76,"country":62,"contacts":77,"geoPoint":82},"58104",[78,79],{"name":65,"role":66,"phone":67,"email":68},{"name":80,"role":81},"Anna M. Strahm, PhD","PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},{"facility":11,"city":84,"state":85,"zip":86,"country":62,"contacts":87,"geoPoint":90},"Sioux Falls","South Dakota","57104",[88,89],{"name":65,"role":66,"phone":67,"email":68},{"name":80,"role":81},{"lat":91,"lon":92},43.54369,-96.72796,[94],{"name":65,"role":66,"phone":67,"email":95},"strahmlab@sanfordhealth.org",[97],{"name":80,"affiliation":11,"role":81},[],[],{"nct_id":4,"conditions":101,"biomarkers":102},[17],[],{"nct_id":4,"found":40,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an observational study planning to enroll 50 women. It is not testing a specific treatment, but rather observing health factors.","completed","Observational Study: Glucose Levels and Body Image in Mid-Pregnancy","This observational study is looking at how blood sugar levels and body image relate to pregnancy outcomes in women. Researchers want to understand why some women develop gestational diabetes (diabetes during pregnancy) even without common risk factors. You might be able to join if you are at least 18 years old, have a healthy single baby pregnancy, and are between 14 and 28 weeks pregnant. You cannot join if you have a history of diabetes, gestational diabetes, heart disease, or endocrine disease, or if you conceived using IVF. The study will measure your continuous blood glucose (blood sugar) using a Dexcom G7 device and assess your body image using a questionnaire over 10 days.","Your blood glucose and body image will be measured for 10 days.",114,"You would have your continuous blood glucose measured with a Dexcom G7 device and complete a Body Image in Pregnancy Scale (BIPS) questionnaire over 10 days.","Not stated in the trial record.",[],"v2"]