Metabolic Tracking and Weight Gain During Pregnancy

Gestational Weight Gain Clinical Trial

Official title:

Metabolic Tracking During Pregnancy to Promote Adequate Gestational Weight Gain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131023
• Other study ID #: STUDY00006557
• Status: Completed
• Phase: N/A
• Start date: September 17, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: October 2019
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United States	Arizona Biomedical Collaborative	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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