Gestational Diabetes Mellitus (GDM)NCT07920588
STRONG: SMART Trial
A study testing STRONG Group Prenatal Care, Usual Prenatal Care and Group-Based Gestational Diabetes Education in people with Gestational Diabetes Mellitus (GDM), run by Yale University at 1 site in American Samoa.
Trial summary
Gestational diabetes is a type of diabetes that develops during pregnancy and can increase the risk of health problems for both mothers and babies. Gestational diabetes is particularly common in American Samoa, where there is a need for effective approaches to prevent the condition and help pregnant women manage their… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- STRONG Group Prenatal Care, Usual Prenatal Care and Group-Based Gestational Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteAmerican Samoa
- Study dates
- Mar 2027to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Be 18 years of age or older.
- Be pregnant with one baby (not twins or other multiple pregnancies).
- Be less than 14 weeks pregnant when joining the study.
- Identify as Pacific Islander.
- Be able to communicate in English or Samoan.
Show all 9Show fewer
- Have overweight or obesity before pregnancy, based on body mass index (BMI) thresholds used for Polynesian populations (BMI of 26 kg/m² or higher).
- Have completed an initial prenatal care enrollment visit at Lyndon B. Johnson Tropical Medical Center or a participating community health center.
- Have approval from their prenatal care provider to participate in the study.
Who cannot join
- Individuals cannot participate if they meet any of the following criteria:
- Have been diagnosed with type 1 or type 2 diabetes before pregnancy, or have blood test results indicating diabetes at enrollment.
- Are currently taking medication to lower blood sugar.
- Have a medical condition or are taking medication that could significantly affect blood sugar levels.
- Have previously had weight-loss (bariatric) surgery.
- Have a medical condition that makes physical activity during pregnancy unsafe, as determined by their prenatal care provider.
- Have a pregnancy in which the baby has a known birth defect or another condition that could interfere with the study's assessment of infant health outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelly Sanchez, LCSW, MPH contact
American Samoa1 site
Yale OLaGA Research Center
Nu‘uuli, Pago Pago, 96799
Susie Tarray, 684-699-5221, susie.tarray@yale.edu
Bethel Muasau-Howard, MBBS
About this study
Official title: STRONG Together Raising Our Next Generation: A Sequential Multiple Randomized Trial to Prevent and Treat Gestational Diabetes in American Samoa (STRONG SMART)
Gestational diabetes is a type of diabetes that develops during pregnancy and can increase the risk of health problems for both mothers and babies. Gestational diabetes is particularly common in American Samoa, where there is a need for effective approaches to prevent the condition and help pregnant women manage their blood sugar.
The goal of this clinical trial is to determine whether a group prenatal care program called Strong Together Raising Our Next Generation (STRONG) can reduce the risk of developing gestational diabetes among pregnant women with overweight or obesity in American Samoa. The study will also examine whether additional group-based education and support can improve blood sugar control among women who develop gestational diabetes.
Read more
Researchers will enroll 360 pregnant women aged 18 years or older who are in their first 14 weeks of pregnancy. Participants will be randomly assigned (like flipping a coin) to receive either STRONG group prenatal care or usual individual prenatal care. STRONG combines routine prenatal care with group discussions, education about healthy eating and physical activity, goal setting, and peer support.
At 24-28 weeks of pregnancy, all participants will be screened for gestational diabetes. Women who do not develop gestational diabetes will continue with their assigned prenatal care. Women who develop gestational diabetes will be randomly assigned a second time to receive either additional group-based diabetes education or usual one-on-one diabetes counseling, alongside their ongoing prenatal care.
The main questions the study aims to answer are:
Does STRONG group prenatal care reduce the number of women who develop gestational diabetes compared with usual prenatal care?
Among women who develop gestational diabetes, which combination of prenatal care and diabetes education leads to better blood sugar control?
Researchers will also examine pregnancy and birth outcomes, infant health, and blood sugar levels after delivery. Participants will be followed until approximately six weeks after giving birth.
The findings may help identify effective, culturally appropriate ways to prevent and manage gestational diabetes in American Samoa and similar communities.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- STRONG Group Prenatal Care, Usual Prenatal Care, Group-Based Gestational Diabetes Education, Usual Individual Gestational Diabetes Counseling
- Keywords
- Gestational Diabetes Mellitus (GDM), Group Prenatal Care, Diabetes in Pregnancy, Glycemic Control, Pacific Islander, American Samoa
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRONG Group Prenatal CareBehavioural
STRONG is a contextually adapted group prenatal care intervention developed for pregnant women in American Samoa. The program combines routine individual prenatal clinical assessments with facilitated group education, discussion, goal setting, self-monitoring, and peer support. Sessions address healthy gestational weight gain, locally relevant nutrition and physical activity, gestational diabetes prevention and screening, breastfeeding, postpartum weight management, and postpartum diabetes screening. The intervention emphasizes family and peer support and uses culturally relevant examples and educational materials. Group care is delivered alongside routine clinical services by trained facilitators.
Usual Prenatal CareBehavioural
Participants receive standard individual prenatal care through participating healthcare facilities in American Samoa. Care is provided by local healthcare professionals according to usual clinical practices and includes routine pregnancy assessments, monitoring of maternal and fetal health, recommended gestational diabetes screening, and referrals or additional clinical management when indicated. Participants do not receive the structured STRONG group prenatal care intervention.
Group-Based Gestational Diabetes EducationBehavioural
Also called STRONG+
Participants diagnosed with gestational diabetes mellitus (GDM) at 24-28 weeks of pregnancy receive structured, group-based diabetes education in addition to their assigned prenatal care. The intervention focuses on gestational diabetes self-management, including nutrition, physical activity, blood glucose monitoring, interpretation of glucose results, and problem-solving strategies. Facilitated group discussions provide opportunities for peer support and culturally relevant education. Participants continue to receive routine clinical GDM management, including medication when prescribed by their healthcare provider.
Usual Individual Gestational Diabetes CounselingBehavioural
Participants diagnosed with gestational diabetes mellitus (GDM) at 24-28 weeks of pregnancy receive usual one-on-one gestational diabetes counseling through local healthcare services. Counseling includes individualized advice about nutrition, physical activity, blood glucose monitoring, and diabetes self-management, according to standard clinical practice and available services. Participants continue their assigned prenatal care and receive additional clinical management, including medication when prescribed by their healthcare provider. They do not receive the study's structured group-based GDM education intervention.
| Study group | Role | What they receive |
|---|---|---|
| STRONG Group Prenatal Care Alone | Experimental | This arm includes participants assigned to STRONG group prenatal care in Stage 1 who do not develop gestational diabetes mellitus (GDM) at 24-28 weeks of gestation.
In Stage 1, participants receive culturally adapted group prenatal care combining routine clinical assessment with facilitated education, goal setting, self-monitoring, and peer support.
In Stage 2, participants without GDM continue STRONG prenatal care without additional GDM-specific education or counseling. Receives: Behavioral: STRONG Group Prenatal Care |
| Usual Prenatal Care Alone | Active comparator | This arm includes participants assigned to usual prenatal care in Stage 1 who do not develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks of gestation.
In Stage 1, participants receive standard individual prenatal care through participating healthcare facilities in American Samoa.
In Stage 2, participants without GDM continue usual prenatal care without additional GDM-specific education or counseling. Receives: Behavioral: Usual Prenatal Care |
| STRONG + Group GDM Education | Experimental | This arm includes participants assigned to STRONG group prenatal care in Stage 1 who develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks and are subsequently randomized to group-based GDM education.
In Stage 1, participants receive STRONG group prenatal care.
In Stage 2, participants continue their assigned prenatal care and receive additional group-based GDM education emphasizing diabetes self-management, nutrition, physical activity, blood glucose monitoring, and peer support. All clinical GDM treatment remains under the direction of their healthcare providers. Receives: Behavioral: STRONG Group Prenatal Care; Behavioral: Group-Based Gestational Diabetes Education |
| STRONG + Usual GDM Counseling | Experimental | This arm includes participants assigned to STRONG group prenatal care in Stage 1 who develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks and are subsequently randomized to usual individual GDM counseling.
In Stage 1, participants receive STRONG group prenatal care.
In Stage 2, participants continue their assigned prenatal care and receive usual one-on-one GDM counseling through local healthcare services, including individualized nutrition and diabetes self-management advice as clinically indicated. Receives: Behavioral: STRONG Group Prenatal Care; Behavioral: Usual Individual Gestational Diabetes Counseling |
| Usual Prenatal Care + Group GDM Education | Experimental | This arm includes participants assigned to usual prenatal care in Stage 1 who develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks and are subsequently randomized to group-based GDM education.
In Stage 1, participants receive standard individual prenatal care through participating healthcare facilities.
In Stage 2, participants continue usual prenatal care and receive additional group-based GDM education emphasizing diabetes self-management, nutrition, physical activity, blood glucose monitoring, and peer support. All clinical GDM treatment remains under the direction of their healthcare providers. Receives: Behavioral: Usual Prenatal Care; Behavioral: Group-Based Gestational Diabetes Education |
| Usual Prenatal Care + Usual GDM Counseling | Active comparator | This arm includes participants assigned to usual prenatal care in Stage 1 who develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks and are subsequently randomized to usual individual GDM counseling.
In Stage 1, participants receive standard individual prenatal care through participating healthcare facilities.
In Stage 2, participants continue usual prenatal care and receive usual one-on-one GDM counseling through local healthcare services, including individualized nutrition and diabetes self-management advice as clinically indicated. Receives: Behavioral: Usual Prenatal Care; Behavioral: Usual Individual Gestational Diabetes Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Gestational Diabetes Mellitus (GDM)
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.
Measured: 24-28 weeks of gestation
Continuous Glucose Monitoring Time in Range at 30-32 Weeks
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.
Measured: 30-32 weeks of gestation
Continuous Glucose Monitoring Time in Range at 36-38 Weeks
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.
Measured: 36-38 weeks of gestation
Secondary outcomes (5)
Incidence of Preterm Birth
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.
Measured: At delivery (before 37 completed weeks of gestation)
Incidence of Cesarean Birth
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.
Measured: At delivery
Incidence of Macrosomia (Birthweight Greater Than 4,000 g)
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.
Measured: At birth
Incidence of Neonatal Hypoglycemia
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.
Measured: From birth to 6 weeks of age
Incidence of Postpartum Dysglycemia at Approximately 6 Weeks
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.
Measured: Approximately 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startMar 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Nicola L Hawley, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920588
- Sponsor's protocol ID
- 2000043558
- Other IDs
- R01HD120157
- Status last verified
- Nov 2026
- First submitted
- 20 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying published study findings will be shared through the NICHD Data and Specimen Hub (DASH), an NIH controlled-access repository. Shared datasets may include questionnaire, clinical, medical record-derived, anthropometric, continuous glucose monitoring, and derived analytic data. Only data from participants who consent to secondary data sharing, and for whom applicable Institutional Review Board (IRB) determinations permit sharing, will be made available. Access will require approval through the NICHD DASH Data Access Committee, execution of a Data Use Agreement, and compliance with study-specific data-use restrictions, including applicable American Samoa IRB requirements. Direct identifiers and participant linkage files will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRONG Together Raising Our Next Generation: A Sequential Multiple Randomized Trial to Prevent and Treat Gestational Diabetes in American Samoa (STRONG SMART)
- ClinicalTrials.gov ID
- NCT07920588
- Acronym / sponsor ID
- 2000043558
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational Diabetes Mellitus (GDM), Group Prenatal Care, Diabetes in Pregnancy, Glycemic Control, Pacific Islander, American Samoa
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gestational diabetes is a type of diabetes that develops during pregnancy and can increase the risk of health problems for both mothers and babies. Gestational diabetes is particularly common in American Samoa, where there is a need for effective approaches to prevent the condition and help pregnant women manage their blood sugar.
The goal of this clinical trial is to determine whether a group prenatal care program called Strong Together Raising Our Next Generation (STRONG) can reduce the risk of developing gestational diabetes among pregnant women with overweight or obesity in American Samoa. The study will also examine whether additional group-based education and support can improve blood sugar control among women who develop gestational diabetes.
Researchers will enroll 360 pregnant women aged 18 years or older who are in their first 14 weeks of pregnancy. Participants will be randomly assigned (like flipping a coin) to receive either STRONG group prenatal care or usual individual prenatal care. STRONG combines routine prenatal care with group discussions, education about healthy eating and physical activity, goal setting, and peer support.
At 24-28 weeks of pregnancy, all participants will be screened for gestational diabetes. Women who do not develop gestational diabetes will continue with their assigned prenatal care. Women who develop gestational diabetes will be randomly assigned a second time to receive either additional group-based diabetes education or usual one-on-one diabetes counseling, alongside their ongoing prenatal care.
The main questions the study aims to answer are:
Does STRONG group prenatal care reduce the number of women who develop gestational diabetes compared with usual prenatal care?
Among women who develop gestational diabetes, which combination of prenatal care and diabetes education leads to better blood sugar control?
Researchers will also examine pregnancy and birth outcomes, infant health, and blood sugar levels after delivery. Participants will be followed until approximately six weeks after giving birth.
The findings may help identify effective, culturally appropriate ways to prevent and manage gestational diabetes in American Samoa and similar communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| STRONG Group Prenatal Care Alone | Experimental | Behavioral: STRONG Group Prenatal CareThis arm includes participants assigned to STRONG group prenatal care in Stage 1 who do not develop gestational diabetes mellitus (GDM) at 24-28 weeks of gestation. In Stage 1, participants receive culturally adapted group prenatal care combining routine clinical assessment with facilitated education, goal setting, self-monitoring, and peer support. In Stage 2, participants without GDM continue STRONG prenatal care without additional GDM-specific education or counseling. |
| Usual Prenatal Care Alone | Active comparator | Behavioral: Usual Prenatal CareThis arm includes participants assigned to usual prenatal care in Stage 1 who do not develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks of gestation. In Stage 1, participants receive standard individual prenatal care through participating healthcare facilities in American Samoa. In Stage 2, participants without GDM continue usual prenatal care without additional GDM-specific education or counseling. |
| STRONG + Group GDM Education | Experimental | Behavioral: STRONG Group Prenatal Care, Behavioral: Group-Based Gestational Diabetes EducationThis arm includes participants assigned to STRONG group prenatal care in Stage 1 who develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks and are subsequently randomized to group-based GDM education. In Stage 1, participants receive STRONG group prenatal care. In Stage 2, participants continue their assigned prenatal care and receive additional group-based GDM education emphasizing diabetes self-management, nutrition, physical activity, blood glucose monitoring, and peer support. All clinical GDM treatment remains under the direction of their healthcare providers. |
| STRONG + Usual GDM Counseling | Experimental | Behavioral: STRONG Group Prenatal Care, Behavioral: Usual Individual Gestational Diabetes CounselingThis arm includes participants assigned to STRONG group prenatal care in Stage 1 who develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks and are subsequently randomized to usual individual GDM counseling. In Stage 1, participants receive STRONG group prenatal care. In Stage 2, participants continue their assigned prenatal care and receive usual one-on-one GDM counseling through local healthcare services, including individualized nutrition and diabetes self-management advice as clinically indicated. |
| Usual Prenatal Care + Group GDM Education | Experimental | Behavioral: Usual Prenatal Care, Behavioral: Group-Based Gestational Diabetes EducationThis arm includes participants assigned to usual prenatal care in Stage 1 who develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks and are subsequently randomized to group-based GDM education. In Stage 1, participants receive standard individual prenatal care through participating healthcare facilities. In Stage 2, participants continue usual prenatal care and receive additional group-based GDM education emphasizing diabetes self-management, nutrition, physical activity, blood glucose monitoring, and peer support. All clinical GDM treatment remains under the direction of their healthcare providers. |
| Usual Prenatal Care + Usual GDM Counseling | Active comparator | Behavioral: Usual Prenatal Care, Behavioral: Usual Individual Gestational Diabetes CounselingThis arm includes participants assigned to usual prenatal care in Stage 1 who develop Gestational Diabetes Mellitus (GDM) at 24-28 weeks and are subsequently randomized to usual individual GDM counseling. In Stage 1, participants receive standard individual prenatal care through participating healthcare facilities. In Stage 2, participants continue usual prenatal care and receive usual one-on-one GDM counseling through local healthcare services, including individualized nutrition and diabetes self-management advice as clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be 18 years of age or older.
- Be pregnant with one baby (not twins or other multiple pregnancies).
- Be less than 14 weeks pregnant when joining the study.
- Identify as Pacific Islander.
- Be able to communicate in English or Samoan.
Key exclusion criteria (7 listed)
- Have been diagnosed with type 1 or type 2 diabetes before pregnancy, or have blood test results indicating diabetes at enrollment.
- Are currently taking medication to lower blood sugar.
- Have a medical condition or are taking medication that could significantly affect blood sugar levels.
- Have previously had weight-loss (bariatric) surgery.
- Have a medical condition that makes physical activity during pregnancy unsafe, as determined by their prenatal care provider.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRONG Group Prenatal CareSTRONG is a contextually adapted group prenatal care intervention developed for pregnant women in American Samoa. The program combines routine individual prenatal clinical assessments with facilitated group education, discussion, goal setting, self-monitoring, and peer support. Sessions address healthy gestational weight gain, locally relevant nutrition and physical activity, gestational diabetes prevention and screening, breastfeeding, postpartum weight management, and postpartum diabetes screening. The intervention emphasizes family and peer support and uses culturally relevant examples and educational materials. Group care is delivered alongside routine clinical services by trained facilitators. | Behavioural | STRONG + Group GDM Education, STRONG + Usual GDM Counseling, STRONG Group Prenatal Care Alone |
| Usual Prenatal CareParticipants receive standard individual prenatal care through participating healthcare facilities in American Samoa. Care is provided by local healthcare professionals according to usual clinical practices and includes routine pregnancy assessments, monitoring of maternal and fetal health, recommended gestational diabetes screening, and referrals or additional clinical management when indicated. Participants do not receive the structured STRONG group prenatal care intervention. | Behavioural | Usual Prenatal Care + Group GDM Education, Usual Prenatal Care + Usual GDM Counseling, Usual Prenatal Care Alone |
| Group-Based Gestational Diabetes EducationAlso: STRONG+Participants diagnosed with gestational diabetes mellitus (GDM) at 24-28 weeks of pregnancy receive structured, group-based diabetes education in addition to their assigned prenatal care. The intervention focuses on gestational diabetes self-management, including nutrition, physical activity, blood glucose monitoring, interpretation of glucose results, and problem-solving strategies. Facilitated group discussions provide opportunities for peer support and culturally relevant education. Participants continue to receive routine clinical GDM management, including medication when prescribed by their healthcare provider. | Behavioural | STRONG + Group GDM Education, Usual Prenatal Care + Group GDM Education |
| Usual Individual Gestational Diabetes CounselingParticipants diagnosed with gestational diabetes mellitus (GDM) at 24-28 weeks of pregnancy receive usual one-on-one gestational diabetes counseling through local healthcare services. Counseling includes individualized advice about nutrition, physical activity, blood glucose monitoring, and diabetes self-management, according to standard clinical practice and available services. Participants continue their assigned prenatal care and receive additional clinical management, including medication when prescribed by their healthcare provider. They do not receive the study's structured group-based GDM education intervention. | Behavioural | STRONG + Usual GDM Counseling, Usual Prenatal Care + Usual GDM Counseling |
Primary outcome
Incidence of Gestational Diabetes Mellitus (GDM)
Time frame: 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.
Continuous Glucose Monitoring Time in Range at 30-32 Weeks
Time frame: 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.
Continuous Glucose Monitoring Time in Range at 36-38 Weeks
Time frame: 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.
5 secondary outcomes
Incidence of Preterm Birth
Time frame: At delivery (before 37 completed weeks of gestation)
Incidence of Cesarean Birth
Time frame: At delivery
Incidence of Macrosomia (Birthweight Greater Than 4,000 g)
Time frame: At birth
Incidence of Neonatal Hypoglycemia
Time frame: From birth to 6 weeks of age
Incidence of Postpartum Dysglycemia at Approximately 6 Weeks
Time frame: Approximately 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying published study findings will be shared through the NICHD Data and Specimen Hub (DASH), an NIH controlled-access repository. Shared datasets may include questionnaire, clinical, medical record-derived, anthropometric, continuous glucose monitoring, and derived analytic data. Only data from participants who consent to secondary data sharing, and for whom applicable Institutional Review Board (IRB) determinations permit sharing, will be made available. Access will require approval through the NICHD DASH Data Access Committee, execution of a Data Use Agreement, and compliance with study-specific data-use restrictions, including applicable American Samoa IRB requirements. Direct identifiers and participant linkage files will not be shared.
Related trials for Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Sanchez, LCSW, MPH contact
Nicola L Hawley, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRONG Group Prenatal Care, Usual Prenatal Care and Group-Based Gestational Diabetes Education in people with Gestational Diabetes Mellitus (GDM), run by Yale University at 1 site in American Samoa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in American Samoa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola L Hawley, PhD (203-737-6781, nicola.hawley@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Gestational Diabetes Mellitus (GDM) (time frame: 24-28 weeks of gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.