Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | STRONG: SMART Trial | ClinicalTrials.gov |
| NCT number | NCT07920588 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 360 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Yale University | ClinicalTrials.gov |
| Conditions | Gestational Diabetes Mellitus (GDM) | ClinicalTrials.gov |
| Interventions | STRONG Group Prenatal Care, Usual Prenatal Care, Group-Based Gestational Diabetes Education, Usual Individual Gestational Diabetes Counseling | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of Gestational Diabetes Mellitus (GDM) | 24-28 weeks of gestation | The proportion of participants diagnosed with gestational diabetes mellitus (GDM) based on a 75-g, 2-hour oral glucose tolerance test (OGTT), using International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria applied in American Samoa. GDM is defined as one or more of the following plasma glucose values: fasting ≥92 mg/dL, 1-hour ≥180 mg/dL, or 2-hour ≥153 mg/dL. GDM incidence will be compared between participants initially randomized to STRONG group prenatal care and those randomized to usual prenatal care. | ClinicalTrials.gov |
| Primary | Continuous Glucose Monitoring Time in Range at 30-32 Weeks | 30-32 weeks of gestation | Among participants diagnosed with gestational diabetes mellitus (GDM), glycemic control will be assessed using blinded continuous glucose monitoring (CGM). The outcome is the average daily percentage of CGM time spent within the pregnancy target glucose range of 63-140 mg/dL during the 30-32-week monitoring period. Higher percentages indicate better glycemic control. Mean daily time in range will be compared across the four embedded adaptive intervention pathways defined by initial prenatal care assignment and subsequent GDM education assignment. | ClinicalTrials.gov |
| Primary | Continuous Glucose Monitoring Time in Range at 36-38 Weeks | 36-38 weeks of gestation | Among participants diagnosed with gestational diabetes mellitus (GDM), glycemic control will be assessed using blinded continuous glucose monitoring (CGM). The outcome is the average daily percentage of CGM time spent within the pregnancy target glucose range of 63-140 mg/dL during the 36-38-week monitoring period. Higher percentages indicate better glycemic control. Mean daily time in range will be compared across the four embedded adaptive intervention pathways defined by initial prenatal care assignment and subsequent GDM education assignment. | ClinicalTrials.gov |
| Secondary | Incidence of Preterm Birth | At delivery (before 37 completed weeks of gestation) | The proportion of participants who give birth before 37 completed weeks of gestation, based on the best obstetric estimate of gestational age documented in the delivery medical record. Preterm birth will be classified as a binary outcome (yes/no). Gestational age at birth will also be recorded in completed weeks. | ClinicalTrials.gov |
| Secondary | Incidence of Cesarean Birth | At delivery | The proportion of participants who deliver by cesarean section, as documented in the maternal delivery medical record. Cesarean birth will be classified as a binary outcome (yes/no). Mode of delivery will also be recorded as vaginal, assisted vaginal, planned cesarean, or emergency cesarean for descriptive analyses. | ClinicalTrials.gov |
| Secondary | Incidence of Macrosomia (Birthweight Greater Than 4,000 g) | At birth | The proportion of infants born with a birthweight greater than 4,000 grams, as documented in the infant's birth medical record. Macrosomia will be classified as a binary outcome (yes/no). Birthweight will also be recorded in grams as a continuous measure. | ClinicalTrials.gov |
| Secondary | Incidence of Neonatal Hypoglycemia | From birth to 6 weeks of age | The proportion of infants with documented neonatal hypoglycemia during the birth hospitalization. Neonatal hypoglycemia will be defined as a documented blood glucose value below 2.6 mmol/L (approximately 47 mg/dL), a clinical diagnosis of hypoglycemia, or treatment for hypoglycemia. Infants without documented hypoglycemia, including low-risk infants who are not routinely screened, will be classified as having no documented neonatal hypoglycemia. | ClinicalTrials.gov |
| Secondary | Incidence of Postpartum Dysglycemia at Approximately 6 Weeks | Approximately 6 weeks postpartum | The proportion of participants with abnormal glucose regulation at approximately six weeks postpartum, assessed using a 75-g, 2-hour oral glucose tolerance test (OGTT). Postpartum dysglycemia will be defined as a fasting plasma glucose of 100 mg/dL or greater and/or a 2-hour plasma glucose of 140 mg/dL or greater. Fasting glucose of 100-125 mg/dL or 2-hour glucose of 140-199 mg/dL indicates prediabetes, while fasting glucose of 126 mg/dL or greater or 2-hour glucose of 200 mg/dL or greater indicates provisional diabetes requiring clinical confirmation. | ClinicalTrials.gov |
| Other | Total Gestational Weight Gain (kg) | Enrollment (before 14 weeks of gestation) through the last prenatal weight assessment (up to delivery). | Total gestational weight gain will be calculated in kilograms as the difference between the participant's measured weight at enrollment (before 14 weeks of gestation) and the last available prenatal weight. | ClinicalTrials.gov |
| Other | Prevalence of Exclusive Breastfeeding at 6 Weeks Postpartum | Approximately 6 weeks postpartum. | The proportion of participants who report providing only breast milk to their infant at approximately six weeks postpartum, assessed by maternal questionnaire. Exclusive breastfeeding will be defined as feeding the infant breast milk, either directly from the breast or as expressed breast milk, without supplementation with formula or other foods or liquids. | ClinicalTrials.gov |
| Other | Intervention Reach Among Screened Pregnant Women | Throughout the recruitment period (approximately 3 years). | Intervention reach will be assessed using study recruitment and eligibility logs. The measure will be calculated as the percentage of eligible women who enroll and are randomized into the study, among all eligible women identified during recruitment. Recruitment and eligibility counts will also be summarized to characterize the study population and potential reach of the intervention. | ClinicalTrials.gov |
| Other | Participant Retention Through Postpartum Follow-up | Enrollment through approximately 6 weeks postpartum. | Participant retention will be measured as the percentage of randomized participants who complete each major scheduled research assessment, including gestational diabetes screening at 24-28 weeks, late-pregnancy assessment at 36-38 weeks, and postpartum assessment at approximately six weeks after delivery. Retention will be calculated using the number of participants randomized as the denominator. | ClinicalTrials.gov |
| Other | Proportion of Expected Prenatal Care Visits Completed | From randomization (before 14 weeks of gestation) through delivery. | Prenatal care engagement will be assessed as the percentage of expected prenatal care visits completed during pregnancy. For each participant, the number of attended prenatal care visits will be divided by the number of visits expected based on gestational age at enrollment, gestational age at delivery, and the recommended prenatal care schedule. STRONG group prenatal care sessions and usual individual prenatal care appointments will both count as completed prenatal care visits. Higher percentages indicate greater engagement with assigned prenatal care. | ClinicalTrials.gov |
| Other | Dose of STRONG Group Prenatal Care Received | From randomization through delivery. | Intervention dose will be assessed among participants randomized to STRONG group prenatal care as the number and proportion of scheduled STRONG group sessions attended during pregnancy. The proportion will be calculated by dividing the number of sessions attended by the number of sessions scheduled for each participant. Higher values indicate greater exposure to the structured STRONG intervention. | ClinicalTrials.gov |
| Other | Fidelity to the STRONG Intervention Protocol | Throughout intervention delivery during pregnancy (up to delivery). | Intervention fidelity will be assessed using a standardized study checklist applied to monthly audio-recorded group intervention sessions. Fidelity will be calculated as the percentage of required intervention elements delivered during assessed sessions. Higher percentages indicate greater fidelity to the intervention protocol. | ClinicalTrials.gov |
| Other | Participant-Reported Acceptability of STRONG Group Prenatal Care | During pregnancy and through approximately 6 weeks postpartum. | Acceptability of the STRONG group prenatal care intervention will be assessed using a structured participant questionnaire developed for the original STRONG pilot trial. Responses will be summarized to describe participants' experiences, satisfaction, and preferences regarding the group prenatal care model. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01HD120157 | STRONG: a group prenatal care intervention to reduce gestational diabetes among women in American Samoa | Hawley, Nicola | YALE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT | 2026 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)