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Metabolic Tracking and Weight Gain During Pregnancy

Primary Purpose

Gestational Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breezing Metabolic Rate Tracking
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Weight Gain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Arizona Biomedical Collaborative

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Metabolic Tracking

Standard Care

Arm Description

Metabolism (indirect calorimetry) tracking was performed

Metabolic (indirect calorimetry tracking was not performed

Outcomes

Primary Outcome Measures

Change in Gestational Weight Gain
Change in body weight from study baseline to 13 weeks
Change in Resting Energy Expenditure
Change in resting energy expenditure, measued by indirect calorimetry, from study baseline to 13 weeks

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
October 15, 2019
Last Updated
October 17, 2019
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT04131023
Brief Title
Metabolic Tracking and Weight Gain During Pregnancy
Official Title
Metabolic Tracking During Pregnancy to Promote Adequate Gestational Weight Gain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Weight Gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metabolic Tracking
Arm Type
Experimental
Arm Description
Metabolism (indirect calorimetry) tracking was performed
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Metabolic (indirect calorimetry tracking was not performed
Intervention Type
Behavioral
Intervention Name(s)
Breezing Metabolic Rate Tracking
Intervention Description
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 Outcome Measure Information:
Title
Change in Gestational Weight Gain
Description
Change in body weight from study baseline to 13 weeks
Time Frame
0 weeks, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 11 weeks, 13 weeks
Title
Change in Resting Energy Expenditure
Description
Change in resting energy expenditure, measued by indirect calorimetry, from study baseline to 13 weeks
Time Frame
0 weeks, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 11 weeks, 13 weeks
Secondary Outcome Measure Information:
Title
Change in Total Sleep Time
Description
Change in total sleep time, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks
Time Frame
0 weeks, 5 weeks, 11 weeks
Title
Change in Sleep Onset Latency
Description
Change in sleep onset latency, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks
Time Frame
0 weeks, 5 weeks, 11 weeks
Title
Change in Wake After Sleep Onset
Description
Change in wake after sleep onset, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks
Time Frame
0 weeks, 5 weeks, 11 weeks
Title
Change in Mid-Sleep Point
Description
Change in mid-sleep point, measured by wrist-worn actigraphy on the non-dominant arm, from study baseline to 11 weeks
Time Frame
0 weeks, 5 weeks, 11 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Arizona Biomedical Collaborative
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Metabolic Tracking and Weight Gain During Pregnancy

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