Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention
研究概览
简要总结
This single-arm pilot study will evaluate the feasibility and acceptability of a remotely delivered behavioral lifestyle intervention, adapted from the SmartMoms framework, to promote health gestational weight gain in pregnant women with overweight and obesity. Twelve to sixteen participants will receive weekly virtual motivational interview sessions with trained health coaches, review their daily weight data, step count, and continuous glucose monitoring data, and tailored guidance on physical activity and nutrition. Educational content will be delivered electronically, with peer support provided through a closed online group. A simulated (mock) control arm will be created post hoc from existing records for preliminary comparisons; all enrolled participants will receive the intervention.
详细描述
The purpose of this study is to assess the feasibility of delivering a remotely administered behavioral lifestyle intervention for pregnant women with overweight and obesity, adapted from the established SmartMoms framework, using a simulated (mock) control arm for comparison. This pilot study will enroll approximately 12-16 participants and will focus on evaluating feasibility, acceptability, and preliminary signals of impact to inform a future randomized controlled trial.
The intervention is tailored to the needs of women in Arkansas and aims to promote healthy gestational weight gain through motivational interviewing, physical activity promotion, education on dietary recommendations and self-monitoring. Participants will be encouraged to meet current pregnancy exercise guidelines (>= 30 minutes of moderate-intensity activity on most, if not all days) and to follow a balanced diet consistent with caloric intake recommendations for appropriate gestational weight gain based on individual pre-pregnancy BMI.
Each participant will be provided with an internet connected bodyweight scal, and pedometer for daily self-monitoring. These devices will automatically transmit weight and step data to the study team. Participants will also wear a continuous glucose monitor (CGM) throughout their pregnancy to track temporal glucose patterns, which will be reviewed with the study's registered dietitian (RD) and health coaches.
Intervention delivery will include weekly virtual motivational interview sessions with a trained health coach. Sessions will review weight gain trajectory, dietary intake, physical activity patterns, and CGM data, and will provide tailored behavioral strategies for meeting gestational weight gain goals. Educational materials will be delivered electronically to participants' smartphones. A closed online forum will be available for peer support, following the SmartMoms framework.
The simulated control arm will be generated post hoc by matching trial participants to publicly available datasets based on gestational age, BMI category, and other relevant covariates. This mock control will serve only as a comparator for preliminary analyses; all enrolled participants will receive the active intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The formative phase (Phase I), classified as exempt by the institutional review board will seek participation from individuals meeting the following criteria:
- •Currently pregnant or pregnant within the past 36 months.
- •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 20 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 .
排除标准
- •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 6 months following screening.
结局指标
主要结局
Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention
时间窗: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months
Maternal recruitment and retention rates (total number of participants recruited and retained)
Feasibility data of the modified EMI: SmartMomsAR - Protocol Adherence
时间窗: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months
Adherence to study protocol via process measures. (Percentage of complete data points)
Feasibility data of the modified EMI: SmartMomsAR - Acceptability
时间窗: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months
Acceptability scores from online intervention satisfaction questionnaires, 5 point Likert Scale system
次要结局
- Incidence of appropriate gestational weight gain per 2009 NASM guidelines.(data is derived through study completion, an average of 6 months.)
- Change in healthful lifestyle behaviors - HEI(data is derived through study completion, an average of 6 months.)
- Change in healthful lifestyle behaviors - Steps (Physical Activity)(data is derived through study completion, an average of 6 months.)
- Change in healthful lifestyle behaviors - Glycemic profile(data is derived through study completion, an average of 6 months.)
研究者
Lisa Jansen
Assistant Professor
Arkansas Children's Hospital Research Institute