Metabolic Tracking and Weight Gain During Pregnancy

NCT04131023 | Completed

• 1 other identifier: STUDY00006557
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Weight Gain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Total Sleep Time

  0 weeks, 5 weeks, 11 weeks

• Change in Sleep Onset Latency

  0 weeks, 5 weeks, 11 weeks

• Change in Wake After Sleep Onset

  0 weeks, 5 weeks, 11 weeks

• Change in Mid-Sleep Point

  0 weeks, 5 weeks, 11 weeks

Study Arms (2)

Metabolic Tracking

EXPERIMENTAL

Metabolism (indirect calorimetry) tracking was performed

Behavioral: Breezing Metabolic Rate Tracking

Standard Care

NO INTERVENTION

Metabolic (indirect calorimetry tracking was not performed

Interventions

Breezing Metabolic Rate Tracking 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.

Metabolic Tracking

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All English and Spanish-speaking, pregnant women
• Gestational age \< 17 weeks at time of recruitment
• Aged 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85007, United States

Location

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: September 17, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)