Early access
Sign in
Not yet recruitingNo phase

STRONG: SMART Trial

Key facts

Who runs it
Yale University
Where
American Samoa1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
360 people, planned
Starts
Mar 2027
Expected to end
Feb 2031
Type of study
Interventional, 6 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • STRONG Group Prenatal Care
  • Usual Prenatal Care
  • Group-Based Gestational Diabetes Education
  • Usual Individual Gestational Diabetes Counseling
Record updated
5 November 2026

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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
  • 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 take part

  • Are currently taking medication to lower blood sugar
  • Have previously had weight-loss (bariatric) surgery
  • Have been diagnosed with type 1 or type 2 diabetes before pregnancy, or have blood test results indicating diabetes at enrollment
  • Have a medical condition or are taking medication that could significantly affect blood sugar levels
  • 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
  • Individuals cannot participate if they meet any of the following criteria:

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 6 groups in the trial

  • STRONG Group Prenatal Care AloneTreatment being tested

    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.

    Treatment: STRONG Group Prenatal Care

  • Usual Prenatal Care AloneExisting treatment, for comparison

    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.

    Treatment: Usual Prenatal Care

  • STRONG + Group GDM EducationTreatment being tested

    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.

    Treatment: STRONG Group Prenatal Care and Group-Based Gestational Diabetes Education

  • STRONG + Usual GDM CounselingTreatment being tested

    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.

    Treatment: STRONG Group Prenatal Care and Usual Individual Gestational Diabetes Counseling

  • Usual Prenatal Care + Group GDM EducationTreatment being tested

    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.

    Treatment: Usual Prenatal Care and Group-Based Gestational Diabetes Education

  • Usual Prenatal Care + Usual GDM CounselingExisting treatment, for comparison

    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.

    Treatment: Usual Prenatal Care and Usual Individual Gestational Diabetes Counseling

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
STRONG Together Raising Our Next Generation: A Sequential Multiple Randomized Trial to Prevent and Treat Gestational Diabetes in American Samoa (STRONG SMART)
Record updated
5 November 2026