STRONG: SMART Trial

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.

Inclusion Criteria: 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. Exclusion Criteria: 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.