Trial Outcomes & Findings for Sedentary Behavior Reduction in Pregnancy Intervention Study (NCT NCT05093842)
NCT ID: NCT05093842
Last Updated: 2025-01-31
Results Overview
objectively measured using activPAL3 micro
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Randomization to study completion, about 6 months
Results posted on
2025-01-31
Participant Flow
SPRING is a pilot and feasibility randomized clinical trial conducted in the greater Pittsburgh, PA (United States) area between October 2021 and June 2023.
A total of 51 first trimester pregnant individuals at risk for high sedentary behavior and adverse pregnancy outcomes (APO) were randomized 2:1 to a multi-component sedentary behavior reduction intervention or no-contact control.
Participant milestones
| Measure |
Sedentary Behavior Reduction Intervention
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
17
|
|
Overall Study
COMPLETED
|
27
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Sedentary Behavior Reduction Intervention
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Overall Study
Pregnancy loss
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Sedentary Behavior Reduction in Pregnancy Intervention Study
Baseline characteristics by cohort
| Measure |
Sedentary Behavior Reduction Intervention
n=34 Participants
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
n=17 Participants
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
32.1 years
STANDARD_DEVIATION 4.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
42 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sedentary Time
|
10.42 hours/day
STANDARD_DEVIATION 0.28 • n=5 Participants
|
10.52 hours/day
STANDARD_DEVIATION 0.40 • n=7 Participants
|
10.47 hours/day
STANDARD_DEVIATION 0.34 • n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to study completion, about 6 monthsPopulation: Two participants were removed from this analysis due to miscarriage after randomization.
objectively measured using activPAL3 micro
Outcome measures
| Measure |
Sedentary Behavior Reduction Intervention
n=33 Participants
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
n=16 Participants
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Sedentary Time
Baseline Sedentary Time
|
10.42 total hours/day
Standard Deviation 0.28
|
10.52 total hours/day
Standard Deviation 0.40
|
|
Sedentary Time
Follow-Up Sedentary Time
|
9.62 total hours/day
Standard Deviation 0.29
|
10.38 total hours/day
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: Randomization to study completion, about 6 monthsPopulation: Two participants were removed from this analysis due to miscarriage after randomization.
Objectively measured using activPAL3 micro
Outcome measures
| Measure |
Sedentary Behavior Reduction Intervention
n=33 Participants
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
n=16 Participants
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Standing
Baseline Standing
|
2.79 hours/day
Standard Deviation 0.20
|
2.74 hours/day
Standard Deviation 0.29
|
|
Standing
Follow-Up Standing
|
3.81 hours/day
Standard Deviation 0.26
|
2.81 hours/day
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: Randomization to study completion, about 6 monthsPopulation: Two participants were removed from this analysis due to miscarriage after randomization.
Objectively measured using activPAL3 micro
Outcome measures
| Measure |
Sedentary Behavior Reduction Intervention
n=33 Participants
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
n=16 Participants
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Steps Per Day
Baseline Steps per day
|
5224 steps per day
Standard Deviation 502
|
6268 steps per day
Standard Deviation 895
|
|
Steps Per Day
Follow-Up Steps per day
|
6777 steps per day
Standard Deviation 656
|
6479 steps per day
Standard Deviation 919
|
SECONDARY outcome
Timeframe: Active recruitment phase, about 1 yearParticipants screened for eligibility
Outcome measures
| Measure |
Sedentary Behavior Reduction Intervention
n=140 Participants
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Recruitment
Pitt+Me Research Registry
|
69 Participants
|
—
|
|
Recruitment
Maternal Fetal Medicine Patient Referral
|
38 Participants
|
—
|
|
Recruitment
E-mail Advertisements to Pitt Community
|
27 Participants
|
—
|
|
Recruitment
Other (personal referrals, internet searches, and flyers)
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Beginning of randomization to 2nd trimester and 3rd trimesterNumber of randomized intervention and control participants remaining at each follow up timepoint
Outcome measures
| Measure |
Sedentary Behavior Reduction Intervention
n=34 Participants
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
n=17 Participants
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Retention
2nd Trimester Follow Up
|
30 Participants
|
16 Participants
|
|
Retention
3rd Trimester Follow Up
|
27 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Randomization to study completion, about 6 monthsPopulation: Initially, there were 34 Intervention participants. One participant was removed from this Intention To Treat analysis due to miscarriage after randomization.
Percentage of intervention contacts completed. This includes behavioral lessons and check-ins.
Outcome measures
| Measure |
Sedentary Behavior Reduction Intervention
n=33 Participants
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Intervention Adherence to Behavioral Coaching Contacts
|
85.5 percentage of contacts
Interval 70.0 to 94.0
|
—
|
SECONDARY outcome
Timeframe: Second and third trimester visit. Two participants were removed from this analysis due to miscarriage after randomization.Population: Randomized participants with single gestation pregnancy
Number of participants that have complete objective sedentary time and other outcome data
Outcome measures
| Measure |
Sedentary Behavior Reduction Intervention
n=33 Participants
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
n=16 Participants
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Outcome Assessment Rates
2nd Trimester
|
30 Participants
|
16 Participants
|
|
Outcome Assessment Rates
3rd Trimester
|
27 Participants
|
15 Participants
|
Adverse Events
Sedentary Behavior Reduction Intervention
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Usual Care Control
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sedentary Behavior Reduction Intervention
n=34 participants at risk
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
n=17 participants at risk
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Infections and infestations
COVID
|
0.00%
0/34 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
5.9%
1/17 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
Other adverse events
| Measure |
Sedentary Behavior Reduction Intervention
n=34 participants at risk
Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.
Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed).
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
Usual Care Control
n=17 participants at risk
Printable information on physical activity recommendations only
Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mole Excision
|
2.9%
1/34 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
0.00%
0/17 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Infections and infestations
UTI
|
2.9%
1/34 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
0.00%
0/17 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Musculoskeletal and connective tissue disorders
Neck, Spine, & TMJ Disorder
|
2.9%
1/34 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
0.00%
0/17 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Respiratory, thoracic and mediastinal disorders
Headaches & Nosebleeds
|
0.00%
0/34 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
5.9%
1/17 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/34 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
5.9%
1/17 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Psychiatric disorders
Start of New Medication
|
0.00%
0/34 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
5.9%
1/17 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/34 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
5.9%
1/17 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Musculoskeletal and connective tissue disorders
Mild and general tailbone discomfort
|
0.00%
0/34 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
5.9%
1/17 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Pregnancy, puerperium and perinatal conditions
Symphysis Pubis Diastasis
|
2.9%
1/34 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
0.00%
0/17 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Infections and infestations
Sinus Infection
|
2.9%
1/34 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
0.00%
0/17 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
0.00%
0/17 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/34 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
5.9%
1/17 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
|
Blood and lymphatic system disorders
Low Iron Level
|
2.9%
1/34 • Number of events 1 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
0.00%
0/17 • 3 Months
Adverse events were collected from systematic questioning at assessment visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place