Clinical trial NCT04131023: Metabolic Tracking and Weight Gain During Pregnancy
Official title: Metabolic Tracking During Pregnancy to Promote Adequate Gestational Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Weight Gain
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All English and Spanish-speaking, pregnant women
* Gestational age \< 17 weeks at time of recruitment
* Aged 18 years or older

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Gestational Weight Gain
timeFrame: 0 weeks, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 11 weeks, 13 weeks
measure: Change in Resting Energy Expenditure
timeFrame: 0 weeks, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 11 weeks, 13 weeks
Secondary outcomes:
measure: Change in Total Sleep Time
timeFrame: 0 weeks, 5 weeks, 11 weeks
measure: Change in Sleep Onset Latency
timeFrame: 0 weeks, 5 weeks, 11 weeks
measure: Change in Wake After Sleep Onset
timeFrame: 0 weeks, 5 weeks, 11 weeks
measure: Change in Mid-Sleep Point
timeFrame: 0 weeks, 5 weeks, 11 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative
state: Arizona
Study officials:
References: