Trial Outcomes & Findings for The Project Wellness Pilot Feasibility Randomized Controlled Trial (NCT NCT04209348)
NCT ID: NCT04209348
Last Updated: 2024-02-12
Results Overview
Change in self-reported moderate to vigorous intensity walking or running activity within the sports \& exercise domain, as assessed by Pregnancy Physical Activity Questionnaire (i.e., measure at follow-up study visit minus the measure at baseline study visit). Reference: Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and Validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004;36(10):1750-1760.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
approximately 6 weeks
Results posted on
2024-02-12
Participant Flow
Participant milestones
| Measure |
Physical Activity Intervention
The behavioral physical activity (PA) intervention focuses on walking, or stepping in place when it is not possible to walk (e.g., stormy weather). The primary goal of the PA intervention is to achieve at least 30 minutes per day of walking/stepping in place. The secondary goal is to use a PA tracker (e.g., the Fitbit Charge 3 provided by the intervention) to log and review walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of walking/stepping each day.
|
Wellness Education
The Wellness Education intervention will deliver information on mom and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., immunizations during pregnancy and encouragement to immunize the baby on schedule, postpartum contraceptive options and developing a contraceptive plan, infant car seats \& safety checks).
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Physical Activity Intervention
The behavioral physical activity (PA) intervention focuses on walking, or stepping in place when it is not possible to walk (e.g., stormy weather). The primary goal of the PA intervention is to achieve at least 30 minutes per day of walking/stepping in place. The secondary goal is to use a PA tracker (e.g., the Fitbit Charge 3 provided by the intervention) to log and review walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of walking/stepping each day.
|
Wellness Education
The Wellness Education intervention will deliver information on mom and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., immunizations during pregnancy and encouragement to immunize the baby on schedule, postpartum contraceptive options and developing a contraceptive plan, infant car seats \& safety checks).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
The Project Wellness Pilot Feasibility Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Physical Activity Intervention
n=10 Participants
The behavioral physical activity (PA) intervention focuses on walking, or stepping in place when it is not possible to walk (e.g., stormy weather). The primary goal of the PA intervention is to achieve at least 30 minutes per day of walking/stepping in place. The secondary goal is to use a PA tracker (e.g., the Fitbit Charge 3 provided by the intervention) to log and review walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of walking/stepping each day.
Physical Activity Intervention: Participants in both arms will wear the CGM (FDA-regulated device)
|
Wellness Education
n=10 Participants
The Wellness Education intervention will deliver information on mom and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., immunizations during pregnancy and encouragement to immunize the baby on schedule, postpartum contraceptive options and developing a contraceptive plan, infant car seats \& safety checks).
Wellness Education: Participants in both arms will wear the CGM (FDA-regulated device)
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 6 weeksChange in self-reported moderate to vigorous intensity walking or running activity within the sports \& exercise domain, as assessed by Pregnancy Physical Activity Questionnaire (i.e., measure at follow-up study visit minus the measure at baseline study visit). Reference: Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and Validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004;36(10):1750-1760.
Outcome measures
| Measure |
Physical Activity Intervention
n=9 Participants
The behavioral physical activity (PA) intervention focuses on walking, or stepping in place when it is not possible to walk (e.g., stormy weather). The primary goal of the PA intervention is to achieve at least 30 minutes per day of walking/stepping in place. The secondary goal is to use a PA tracker (e.g., the Fitbit Charge 3 provided by the intervention) to log and review walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of walking/stepping each day.
|
Wellness Education
n=9 Participants
The Wellness Education intervention will deliver information on mom and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., immunizations during pregnancy and encouragement to immunize the baby on schedule, postpartum contraceptive options and developing a contraceptive plan, infant car seats \& safety checks).
|
|---|---|---|
|
Change in Self-reported Physical Activity (Assessed by Pregnancy Physical Activity Questionnaire) From Baseline to Follow-up
|
0.22 MET hours per week
Interval -0.41 to 0.84
|
-0.70 MET hours per week
Interval -1.31 to -0.1
|
PRIMARY outcome
Timeframe: approximately 6 weeksChange in minutes per day of walk/run activity, as assessed by ActiGraph monitoring device (i.e., measure at follow-up study visit minus the measure at baseline study visit). Reference: Hibbing PR, Lamunion SR, Kaplan AS, Crouter SE. Estimating Energy Expenditure with ActiGraph GT9X Inertial Measurement Unit. Med Sci Sports Exerc. May 2018;50(5):1093-1102.
Outcome measures
| Measure |
Physical Activity Intervention
n=9 Participants
The behavioral physical activity (PA) intervention focuses on walking, or stepping in place when it is not possible to walk (e.g., stormy weather). The primary goal of the PA intervention is to achieve at least 30 minutes per day of walking/stepping in place. The secondary goal is to use a PA tracker (e.g., the Fitbit Charge 3 provided by the intervention) to log and review walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of walking/stepping each day.
|
Wellness Education
n=8 Participants
The Wellness Education intervention will deliver information on mom and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., immunizations during pregnancy and encouragement to immunize the baby on schedule, postpartum contraceptive options and developing a contraceptive plan, infant car seats \& safety checks).
|
|---|---|---|
|
Change in Physical Activity Assessed by ActiGraph Monitoring Device From Baseline to Follow-up
|
0.90 Minutes per day of walk/run activity
Interval 0.53 to 1.54
|
-1.58 Minutes per day of walk/run activity
Interval -2.8 to -0.9
|
SECONDARY outcome
Timeframe: Within 5 days of birthPopulation: Subscapular skinfolds
Neonatal Subscapular Skinfolds (i.e., caliper measurement to assess neonatal body composition)
Outcome measures
| Measure |
Physical Activity Intervention
n=7 Participants
The behavioral physical activity (PA) intervention focuses on walking, or stepping in place when it is not possible to walk (e.g., stormy weather). The primary goal of the PA intervention is to achieve at least 30 minutes per day of walking/stepping in place. The secondary goal is to use a PA tracker (e.g., the Fitbit Charge 3 provided by the intervention) to log and review walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of walking/stepping each day.
|
Wellness Education
n=10 Participants
The Wellness Education intervention will deliver information on mom and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., immunizations during pregnancy and encouragement to immunize the baby on schedule, postpartum contraceptive options and developing a contraceptive plan, infant car seats \& safety checks).
|
|---|---|---|
|
Neonatal Subscapular Skinfolds
|
4.37 mm
Interval 3.65 to 5.08
|
5.24 mm
Interval 4.64 to 5.84
|
SECONDARY outcome
Timeframe: Within 5 days of birthBirthweight-for-gestational-age Z-score based on the sex- and gestational-age-specific birth-weight distributions of the 2017 U.S. Natality files. Z-scores more extreme than -1.645 and +1.645 indicate birthweight-for-gestational-age-and-sex at \<10th and \>90th percentiles, respectively, and thus indicate increased risks for adverse health outcomes (as the relationship is U-shaped). A Z-score of 0 represents birthweight-for-gestational-age-and-sex at the 50th percentile. Reference: Aris IM, Kleinman KP, Belfort MB, Kaimal A, Oken E. A 2017 U.S. Reference for Singleton Birth Weight Percentiles Using Obstetric Estimates of Gestation. Pediatrics. Jul 2019;144(1).
Outcome measures
| Measure |
Physical Activity Intervention
n=10 Participants
The behavioral physical activity (PA) intervention focuses on walking, or stepping in place when it is not possible to walk (e.g., stormy weather). The primary goal of the PA intervention is to achieve at least 30 minutes per day of walking/stepping in place. The secondary goal is to use a PA tracker (e.g., the Fitbit Charge 3 provided by the intervention) to log and review walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of walking/stepping each day.
|
Wellness Education
n=10 Participants
The Wellness Education intervention will deliver information on mom and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., immunizations during pregnancy and encouragement to immunize the baby on schedule, postpartum contraceptive options and developing a contraceptive plan, infant car seats \& safety checks).
|
|---|---|---|
|
Birthweight-for-gestational-age Z-score
|
-0.87 Z-score
Interval -1.51 to -0.24
|
-0.064 Z-score
Interval -0.7 to 0.57
|
Adverse Events
Physical Activity Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wellness Education
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
Dr. Samantha Ehrlich
The University of Tennessee, Knoxville
Phone: 510 299 8747
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place