Abstract
BackgroundExcess gestational weight gain (GWG) is common among women with overweight or obesity, increasing their risks for pregnancy complications, delivering a large infant, and postpartum weight retention. To date, only intensive interventions have had success and few interventions have been designed for implementation in healthcare settings.MethodsWe describe the development, rationale, and methods of GLOW (GestationaL Weight Gain and Optimal Wellness), a randomized controlled trial evaluating the efficacy of a lifestyle intervention to prevent excess GWG among racially/ethnically diverse women with overweight or obesity in an integrated healthcare delivery system. Participants in Kaiser Permanente Northern California will be randomized, within 2 weeks of completing a study baseline clinic visit at 10 weeks’ gestation, to either usual medical care or a multi-component pregnancy lifestyle intervention adapted from the Diabetes Prevention Program (target N = 400). Informed by focus groups with patients and designed to be feasible in a clinical setting, the intervention will include 13 weekly individual sessions (11 delivered by telephone) focused on behavior change for weight management, healthy eating, physical activity, and stress management. Outcomes will be assessed in women and their infants from randomization to 12 months postpartum. The primary outcome is GWG. Secondary outcomes include changes in diet and physical activity during pregnancy and infant birthweight. Exploratory outcomes include cardiometabolic profile assessed via pregnancy blood samples and cord blood samples; and postpartum weight retention and infant anthropometrics up to 12 months of age. The trial includes systematic approaches to enhance intervention fidelity, intervention adherence, and participant retention in trial assessments.DiscussionGLOW is among few trials targeting excess GWG among diverse women with overweight or obesity in a healthcare setting, with long-term maternal and infant outcomes assessed up to 12 months after delivery. This evaluation of a multi-component intervention is designed to produce generalizable results to inform potential adoption of the intervention in clinical settings.Trial registrationClinicalTrials.gov (NCT02130232): submitted April 30, 2014; posted May 5, 2014.
Highlights
Excess gestational weight gain (GWG) is common among women with overweight or obesity, increasing their risks for pregnancy complications, delivering a large infant, and postpartum weight retention
Trials arising from the Lifestyle Interventions for Expectant Moms (LIFE-Moms) consortium show that intensive behavioral lifestyle interventions, such as in-person counseling or in-person counseling paired with partial meal replacements, prevent excess GWG among women with overweight or obesity [12]
Gestational Weight Gain and Optimal Wellness (GLOW) is a two-arm, parallel group randomized controlled trial testing the efficacy of a multi-component pregnancy lifestyle intervention adapted from the Diabetes Prevention Program (DPP) [14] and delivered primarily via telemedicine, as compared to usual medical care
Summary
GLOW is a two-arm, parallel group randomized controlled trial testing the efficacy of a multi-component pregnancy lifestyle intervention adapted from the Diabetes Prevention Program (DPP) [14] and delivered primarily via telemedicine, as compared to usual medical care. Pregnant women receiving care at the selected medical centers will be first identified in the electronic health record (EHR) system Those < 8 weeks’ gestational age will be evaluated to confirm eligibility criteria: ≥18 years of age, pre-pregnancy body mass index (BMI) between 25 and 40 kg/m2 (based on weight measured in the clinical setting within 6 months before the last menstrual period), and a singleton pregnancy. Usual care Women randomized to the usual care condition will receive standard KPNC prenatal medical care This includes an initial prenatal visit at 7–10 weeks’ gestation; an additional 7 routine prenatal visits between 16 weeks’ gestation and delivery; and periodic health education newsletters, which include the IOM GWG guidelines and advice on healthy eating and activity in pregnancy. At session 2, participants will receive an initial personalized calorie goal based on their average
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