Trial Outcomes & Findings for Monitoring Movement and Health Study (NCT NCT03084302)

NCT ID: NCT03084302

Last Updated: 2022-10-27

Results Overview

Trajectories identified from objective data across trimesters. High sedentary behavior was defined as the highest group (\~10.9 hr/day) based on growth mixture models from the objective data.

• Recruitment status: COMPLETED
• Target enrollment: 120 participants
• Primary outcome timeframe: 1st, 2nd, and 3rd trimester of pregnancy
• Results posted on: 2022-10-27

Participant Flow

Participant milestones

Measure	Pregnant Women Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers.
Overall Study STARTED	120
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	Pregnant Women Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers.
Overall Study Miscarriage, twin pregnancy, congenital abnormality	9
Overall Study No valid objective monitor data	6

Baseline Characteristics

Monitoring Movement and Health Study

Baseline characteristics by cohort

Measure	Pregnant Women n=105 Participants Women in their first trimester of pregnancy, aged 18-45, who plan to receive their prenatal care from University of Pittsburgh Medical Center providers.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	105 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants
Race (NIH/OMB) White	80 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants

PRIMARY outcome

Timeframe: 1st, 2nd, and 3rd trimester of pregnancy

Trajectories identified from objective data across trimesters. High sedentary behavior was defined as the highest group (~10.9 hr/day) based on growth mixture models from the objective data.

Outcome measures

Measure	Full Cohort n=105 Participants All participants with at least one valid objective data measure
Number of Participants Classified as Having High Sedentary Behavior (by Trajectory)	45 Participants

PRIMARY outcome

Timeframe: 1st, 2nd, and 3rd trimester of pregnancy

Low levels of physical activity across trimesters, identified by growth mixture modelling. The low trajectory corresponded to about 114 minutes per week or about 16 minutes per day.

Outcome measures

Measure	Full Cohort n=105 Participants All participants with at least one valid objective data measure
Number of Participants Classified as Having Low Moderate-to-vigorous Intensity Physical Activity (by Trajectory)	29 Participants

SECONDARY outcome

Timeframe: at delivery

Population: Women with at least one valid trimester of objective data and available medical records.

from study visits and medical records excessive gestational weight gain was defined using 2009 Institute of Medicine Guidelines (reference: Institute of Medicine and National Research Council. Weight gain during pregnancy: reexamining the guidelines. Washington, DC: The National Academies Press; 2009)

Outcome measures

Measure	Full Cohort n=100 Participants All participants with at least one valid objective data measure
Number of Participants With Excessive Gestational Weight Gain	49 Participants

SECONDARY outcome

Timeframe: during pregnancy

from study visits and medical records includes hypertensive disorders of pregnancy, preterm birth, intrauterine growth restrictions, gestational diabetes

Outcome measures

Measure	Full Cohort n=100 Participants All participants with at least one valid objective data measure
Adverse Pregnancy Outcomes	19 Participants

Adverse Events

Full Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bethany Barone Gibbs, Associate Professor, University of Pittsburgh

University of Pittsburgh

Phone: 412-383-4002

Email: bbarone@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place