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Metabolic Tracking and Weight Gain During Pregnancy

Arizona State University (ASU) logo

Arizona State University (ASU)

Status

Completed

Conditions

Gestational Weight Gain

Treatments

Behavioral: Breezing Metabolic Rate Tracking

Study type

Interventional

Funder types

Other

Identifiers

NCT04131023
STUDY00006557

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Metabolic Tracking
Experimental group
Description:
Metabolism (indirect calorimetry) tracking was performed
Treatment:
Behavioral: Breezing Metabolic Rate Tracking
Standard Care
No Intervention group
Description:
Metabolic (indirect calorimetry tracking was not performed

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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