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Completed

NCT Number: NCT04131023

Metabolic Tracking and Weight Gain During Pregnancy

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.

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Key information

Conditions

Gestational Weight Gain Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Biomedical Collaborative

Phoenix, Arizona, 85007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breezing Metabolic Rate Tracking

Behavioral

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.

Primary outcomes

  1. Change in Gestational Weight Gain

    Time frame: 0 weeks, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 11 weeks, 13 weeks

    Change in body weight from study baseline to 13 weeks

  2. Change in Resting Energy Expenditure

    Time frame: 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

Secondary outcomes

  1. Change in Total Sleep Time

    Time frame: 0 weeks, 5 weeks, 11 weeks

    Change in total sleep time, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks

  2. Change in Sleep Onset Latency

    Time frame: 0 weeks, 5 weeks, 11 weeks

    Change in sleep onset latency, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks

  3. Change in Wake After Sleep Onset

    Time frame: 0 weeks, 5 weeks, 11 weeks

    Change in wake after sleep onset, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks

  4. Change in Mid-Sleep Point

    Time frame: 0 weeks, 5 weeks, 11 weeks

    Change in mid-sleep point, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

Metabolic Tracking During Pregnancy to Promote Adequate Gestational Weight Gain

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2019
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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