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
About this trial
This is an interventional prevention trial for Gestational Weight Gain
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
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
NCT ID
NCT04131023
First Posted
October 15, 2019
Last Updated
October 17, 2019
Sponsor
Arizona State University
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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