Metabolic Tracking and Weight Gain During Pregnancy

NCT ID: NCT04131023

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-17
• Study Completion Date: 2018-11-01

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.

Conditions

Gestational Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Metabolic Tracking

Metabolism (indirect calorimetry) tracking was performed

Group Type: EXPERIMENTAL

Breezing Metabolic Rate Tracking

Intervention Type: 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.

Standard Care

Metabolic (indirect calorimetry tracking was not performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Corrie Whisner

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arizona Biomedical Collaborative

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

STUDY00006557

Identifier Type: -

Identifier Source: org_study_id