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NCT06666257: GEM
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
NA trial testing Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy in Pregnancies at Increased Risk for Excessive Gestational Weight Gain in 16 participants. Not yet recruiting.
30 April 2026
Quick facts
| Lead sponsor | Arkansas Children's Hospital Research Institute |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 16 |
| Start date | 1 October 2025 |
| Primary completion | 30 April 2026 |
| Estimated completion | 30 July 2026 |
Drugs / interventions tested
- Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy
Conditions studied
- Pregnancies at Increased Risk for Excessive Gestational Weight Gain — all drugs for Pregnancies at Increased Risk for Excessive Gestational Weight Gain →
- Ecological Momentary Assessment and Intervention — all drugs for Ecological Momentary Assessment and Intervention →
- Continuous Glucose Monitor — all drugs for Continuous Glucose Monitor →
Sponsor
Arkansas Children's Hospital Research Institute
Who can join
Adults 18 to 45, female only, with Pregnancies at Increased Risk for Excessive Gestational Weight Gain or Ecological Momentary Assessment and Intervention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This single-arm pilot study will evaluate the feasibility and acceptability of a remotely delivered behavioral lifestyle intervention, adapted from the SmartMoms framework, to promote health gestational weight gain in pregnant women with overweight and obesity. Twelve to sixteen participants will receive weekly virtual motivational interview sessions with trained health coaches, review their daily weight data, step count, and continuous glucose monitoring data, and tailored guidance on physical activity and nutrition. Educational content will be delivered electronically, with peer support provided through a closed online group. A simulated (mock) control arm will be created post hoc from existing records for preliminary comparisons; all enrolled participants will receive the intervention.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06666257
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Arkansas Children's Hospital Research Institute trials
Trials by the same sponsor.
- NCT06929091 — Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready · NA · recruiting
- NCT06848478 — Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health i · NA · not yet recruiting
- NCT07107321 — Deimplementation of Inappropriate Feeding Practices in Early Care and Education Settings · NA · enrolling by invitation
- NCT07346300 — We-Move With Windy: Gross Motor Development for Early Childhood · NA · recruiting
- NCT07343700 — Community Expecting: Exercise During Pregnancy · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06666257 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute
- Last refreshed: 15 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06666257.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing