Metabolic Tracking and Weight Gain During Pregnancy

Metabolic Tracking During Pregnancy to Promote Adequate Gestational Weight Gain

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.

Study Overview

• Status: Completed
• Conditions: Gestational Weight Gain
• Intervention / Treatment: Behavioral: Breezing Metabolic Rate Tracking

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85007
      • Arizona Biomedical Collaborative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metabolic Tracking; Metabolism (indirect calorimetry) tracking was performed	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.
No Intervention: Standard Care; Metabolic (indirect calorimetry tracking was not performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gestational Weight Gain	Change in body weight from study baseline to 13 weeks	0 weeks, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 11 weeks, 13 weeks
Change in Resting Energy Expenditure	Change in resting energy expenditure, measued by indirect calorimetry, from study baseline to 13 weeks	0 weeks, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 11 weeks, 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Sleep Time	Change in total sleep time, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks	0 weeks, 5 weeks, 11 weeks
Change in Sleep Onset Latency	Change in sleep onset latency, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks	0 weeks, 5 weeks, 11 weeks
Change in Wake After Sleep Onset	Change in wake after sleep onset, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks	0 weeks, 5 weeks, 11 weeks
Change in Mid-Sleep Point	Change in mid-sleep point, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks	0 weeks, 5 weeks, 11 weeks

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: STUDY00006557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No