Trials / Completed
CompletedNCT04131023
Metabolic Tracking and Weight Gain During Pregnancy
Metabolic Tracking During Pregnancy to Promote Adequate Gestational Weight Gain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Arizona State University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
Specific Aims The investigators pursued the following specific aims: 1. 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. 2. 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 1\. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Breezing Metabolic Rate Tracking | Metabolism (indirect calorimetry) data were collected every two weeks over 13 weeks of gestation across the second trimester (weeks 13-27) and the values obtained were provided to the participant without health education. |
Timeline
- Start date
- 2017-09-17
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
- First posted
- 2019-10-18
- Last updated
- 2019-10-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04131023. Inclusion in this directory is not an endorsement.