continuous glucose and e-monitoring to support healthy weight gain in pregnancies - the gem study

Conditions: Pregnancies at Increased Risk for Excessive Gestational Weight Gain; Ecological Momentary Assessment and Intervention; Continuous Glucose Monitor

Summary: the purpose of this study is to determine the feasibility of adding continuous glucose monitoring (cgm) as a self-monitoring tool to an existing ecological momentary intervention (emi) in pregnant women with obesity but without diabetes. in phase i (formative stage) participants will engage in focus groups or interviews and provide feedback on the existing smartmoms intervention as well as the researcher's plans to integrate cgm. in phase ii, participants will be randomized to either smartmoms or smartmoms+cgm during weeks 12-40 of pregnancy. through participant feedback, compliance and gestational weight gain outcome data feasibility and acceptability scores will be derived.

the purpose of this study is to assess feasibility of adapting an established gestational weight gain intervention approach to the specific needs of women in arkansas. a formative phase will inform appropriate adjustments to existing intervention features as well as the support requested for wearing a continuous glucose monitor and reviewing its data. like the original intervention, the newly adapted intervention will encourage participants to meet the updated exercise guidelines for pregnancy which recommends 30 min or more of moderate exercise a day on most if not all days of the week, and to eat a balanced diet within a caloric intake range conducive to appropriate gestational weight gain. participants will be required to provide a daily bodyweight and step count which will be transmitted automatically with daily use of the provided devices (internet connected bodyweight scale, and pedometer). participants in the intervention group will also wear a cgm sensor throughout pregnancy to track temporal glucose profiles. smartmoms (trademarked) is an evidence based behavioral intervention designed to encourage appropriate gestational weight gain in women with overweight and obesity. women will receive daily prompts and feedback on their current weight gain trajectory. prompts will include educational sessions on healthy eating and exercising during pregnancy and will be delivered electronically to participant's smartphones and email. participants will interact with rd health coaches and review their activity and dietary choices. the intervention group will also review their glycemic patterns in response to these choices with the study rds. to provide participant support, the investigators will establish a closed online forum/group for community support and exchange, following the smartmoms framework. women will be in either smartmoms or smartmoms +cgm for 28 weeks, from week 12 - 40 of pregnancy. all smartmoms counseling sessions will be conducted by a trained research staff member, and the participants will be trained on a one-to-one basis on how to engage with smartmoms and the cgm component safely.

Eligibility criteria:
the formative phase (phase i), classified as exempt by the institutional review board will seek participation from individuals meeting the following criteria: 1. currently pregnant or pregnant within the past 36 months. 2. community partners with relevant perspectives to inform recruitment, adaptation approaches and feasibility of the phase 2 pilot trial. clinical trial (phase 2) inclusion criteria: * pregnant women less than 14 weeks of gestation at time of screening * 18-45 years of age * bmi of 25 - 40 kg/m-2 * expecting a singleton pregnancy * smartphone and/or reliable internet access * willing to be identifiable to other study participants in the study program . exclusion criteria: * smoker * preexisting medical conditions that might be exacerbated by pregnancy (e.g., diabetes mellitus, chronic renal failure, hypertension, malignancies, seizure disorder, lupus, drug or alcohol abuse, serious psychiatric disorders) * current mental health or eating disorder * contraindication to exercise (ob/gyn release is obtained prior to consent) * conceived with assisted fertility treatments * medications during pregnancy known to influence fetal growth (e.g., thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents) * plans to move out of the state in the next 10 months following screening.

Keywords: pregnancy obesity continuous glucose monitoring ecological momentary intervention gestational weight gain overweight