Metabolic Tracking During Pregnancy to Promote Adequate Gestational Weight Gain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Gestational Weight Gain
研究概览
简要总结
In this study, the investigators aimed to have pregnant women use a hand-held device to track increases in daily caloric needs during pregnancy. Weight gain was assessed over time with the goal of reducing excessive gestational weight gain relative to a group of pregnant women who received standard prenatal care.
详细描述
Specific Aims
The investigators pursued the following specific aims:
- Evaluate the impact of a mobile, real-time metabolism tracking device on gestational weight gain (GWG) (i.e. total weight gain and rate of weight gain) in pregnant women. The investigators postulated that the metabolism tracking (Breezing) group would have a higher proportion of women who gain the appropriate amount of weight per IOM recommendations. Further, the investigators expected the women in the Breezing group to gain a mean weight within +/- 3 lbs of their recommended GWG range per IOM guidelines, compared to standard care-receiving controls.
- Assess changes in resting energy expenditure during pregnancy in relation to self-reported dietary intake (at baseline, 4 weeks, 8 weeks, and 12 weeks). The investigators hypothesized that energy requirements would change across the second trimester and that self-reported caloric intakes would correlate with resting energy expenditure (REE)-corrected values (from Breezing) for women in the Breezing group.
Exploratory Aims
- Evaluate the associations among objective and self-reported sleep parameters (actigraphic total sleep time, sleep onset latency, wake after sleep onset, and mid-sleep point; sleep diary total sleep time, sleep onset latency, wake after sleep onset, and mid-sleep point; insomnia symptoms; and sleep disordered breathing risk) and GWG within the Breezing and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All English and Spanish-speaking, pregnant women
- •Gestational age < 17 weeks at time of recruitment
- •Aged 18 years or older
排除标准
- •High-risk pregnancies that include the following diseases or conditions: fetal growth problems, medical history of hypertension, gastrointestinal disorders, malabsorptive diseases, hyper or hypo-parathyroid conditions, HIV, diabetes (Types 1 and 2 or gestational diabetes), asthma/lung disease, cardiac disease or conditions, current smoker (i.e. women who have smoked 100 cigarettes in their lifetime and now smoke every day or some days) history of eating disorder, or other metabolic conditions known to affect maternal health and fetal development
- •Women pregnant with multiple gestations
研究组 & 干预措施
Metabolic Tracking
Metabolism (indirect calorimetry) tracking was performed
干预措施: Breezing Metabolic Rate Tracking (Behavioral)
Standard Care
Metabolic (indirect calorimetry tracking was not performed
结局指标
主要结局
Change in Gestational Weight Gain
时间窗: 0 weeks, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 11 weeks, 13 weeks
Change in body weight from study baseline to 13 weeks
Change in Resting Energy Expenditure
时间窗: 0 weeks, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 11 weeks, 13 weeks
Change in resting energy expenditure, measued by indirect calorimetry, from study baseline to 13 weeks
次要结局
- Change in Total Sleep Time(0 weeks, 5 weeks, 11 weeks)
- Change in Wake After Sleep Onset(0 weeks, 5 weeks, 11 weeks)
- Change in Sleep Onset Latency(0 weeks, 5 weeks, 11 weeks)
- Change in Mid-Sleep Point(0 weeks, 5 weeks, 11 weeks)
研究者
Corrie Whisner
Assistant Professor
Arizona State University