Metabolic Tracking and Weight Gain During Pregnancy

Not Applicable

Completed

• Conditions: Gestational Weight Gain
• Interventions: Behavioral: Breezing Metabolic Rate Tracking

• Registration Number: NCT04131023
• Lead Sponsor: Arizona State University

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.

Study Timeline

• Study Start: 2017-09-17
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-17
• Last Update Submitted: 2019-10-17
• Study First Posted: 2019-10-18
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metabolic Tracking	Breezing Metabolic Rate Tracking	Metabolism (indirect calorimetry) tracking was performed

Primary Outcome Measures

Name	Time	Method
Change in Gestational Weight Gain	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	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 Outcome Measures

Name	Time	Method
Change in Total Sleep Time	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
Change in Wake After Sleep Onset	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
Change in Sleep Onset Latency	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
Change in Mid-Sleep Point	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

Trial Locations

Locations (1)

Arizona Biomedical Collaborative; 🇺🇸 Phoenix, Arizona, United States