Trial Outcomes & Findings for Postpartum Wellness (NCT NCT04414696)
NCT ID: NCT04414696
Last Updated: 2025-08-17
Results Overview
Continuous measure of depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-8). PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
3 months
Results posted on
2025-08-17
Participant Flow
Participant milestones
| Measure |
Intervention
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
3-month Follow up
STARTED
|
50
|
49
|
|
3-month Follow up
COMPLETED
|
27
|
26
|
|
3-month Follow up
NOT COMPLETED
|
23
|
23
|
|
6-month Follow up
STARTED
|
27
|
26
|
|
6-month Follow up
COMPLETED
|
21
|
22
|
|
6-month Follow up
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Intervention
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
3-month Follow up
Withdrawal by Subject
|
1
|
0
|
|
3-month Follow up
Lost to Follow-up
|
22
|
23
|
|
6-month Follow up
Withdrawal by Subject
|
1
|
2
|
|
6-month Follow up
Lost to Follow-up
|
5
|
2
|
Baseline Characteristics
Postpartum Wellness
Baseline characteristics by cohort
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Months postpartum
|
4.1 months
STANDARD_DEVIATION 1.2 • n=5 Participants
|
4 months
STANDARD_DEVIATION 1 • n=7 Participants
|
4.1 months
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Number of children at home
2+
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Number of children at home
1
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Depressive symptons
|
12.6 score on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
12.6 score on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
12.6 score on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Physical activity level prior to pregnancy
Below recommendations
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Physical activity level prior to pregnancy
At or above recommendations
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: After multiple imputation
Continuous measure of depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-8). PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Depression Symptoms
|
10.1 score on a scale
Standard Deviation 5.4
|
11 score on a scale
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: After multiple imputation
Actigraph-measured minutes of moderate/vigorous physical activity
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Device-Measured Physical Activity
|
53.2 minutes per day
Standard Deviation 39.9
|
58 minutes per day
Standard Deviation 44.8
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intent to treat analysis with multiple imputation
Self-reported moderate/vigorous physical activity
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Self-reported Physical Activity
|
15.8 MET-hours per week
Standard Deviation 15.7
|
12.7 MET-hours per week
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat analysis with multiple imputation
Actigraph-measured minutes of moderate/vigorous physical
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Device-measured Physical Activity
|
63.2 minutes per day
Standard Deviation 49.1
|
62.3 minutes per day
Standard Deviation 53.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat analysis with multiple imputation
Continuous measure of depressive symptoms as assessed in the Patient Health Questionnaire (PHQ-8). PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Depressive Symptoms
|
7.9 score on a scale
Standard Deviation 4.9
|
9.1 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to treat analysis with multiple imputation
Self-reported moderate/vigorous physical activity
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Self-reported Physical Activity
|
13.7 MET-hours per week
Standard Deviation 13.8
|
16.3 MET-hours per week
Standard Deviation 16.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Intent to treat analysis with multiple imputation
Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) asks about sleep quality during the past month, including questions on sleep duration, sleep disturbance, and use of sleep-inducing medications. A global score, ranging from 0 to 21, is calculated using seven components of sleep. Higher scores indicate poorer sleep quality.
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Sleep
|
9.6 score on a scale
Standard Deviation 4
|
10.1 score on a scale
Standard Deviation 4.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Intent to treat analysis with multiple imputation
The Mother Infant Bonding Scale will be used to assess mother-infant bonding. Mother Infant Bonding Scale scores range from 0-24. Higher scores indicate worse mother-infant bonding.
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Mother-infant Bonding
|
1.7 score on a scale
Standard Deviation 2.9
|
1.8 score on a scale
Standard Deviation 3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Intent to treat analysis with multiple imputation
The General Anxiety Disorder Scale (GAD-7) will be used to assess anxiety. GAD-7 scores range from 0-21. A score of 1-4 suggests minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Anxiety
|
9.2 score on a scale
Standard Deviation 5.4
|
10 score on a scale
Standard Deviation 5.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Intent to treat analysis with multiple imputation
Perceived stress will be measured using the Perceived Stress Scale (PSS-10). PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. A score of 0-13 suggests low stress, 14-26 moderate stress, and 27-40 high perceived stress.
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Stress
|
21 score on a scale
Standard Deviation 6.7
|
23.2 score on a scale
Standard Deviation 7.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 12 months oldPopulation: Intent to treat analysis with multiple imputation
Ages and Stages questionnaire for 12-month-old infants. The ASQ-3 screens for delays in infant and child development in five domains: communication, gross motor, fine motor, problem-solving, and personal adaptive skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.
Outcome measures
| Measure |
Intervention
n=50 Participants
Participants will be asked to use a web-based (eHealth) exercise intervention for 3 months. This eHealth exercise intervention includes over 90, 10-minute exercise videos with options for exercise type, time, and intensity, customized to the weight of the infant. Users can either select up to three 10-minute videos to create a 10 to 30-minute workout or choose a 'Ready Made' workout that is either 10, 20, or 30-minutes long.
Exercise intervention: eHealth exercise intervention for postpartum women at increased risk of depression
|
Usual Care
n=49 Participants
Participants in the usual care condition will follow their usual standard care as suggested by their provider. Participants will complete the same assessments and incentives as the active intervention but will not receive the eHealth exercise intervention.
|
|---|---|---|
|
Infant Development
Personal-social skills
|
40.1 score on a scale
Standard Deviation 13.5
|
36.9 score on a scale
Standard Deviation 14
|
|
Infant Development
Communication
|
44.6 score on a scale
Standard Deviation 13.9
|
42.1 score on a scale
Standard Deviation 14.7
|
|
Infant Development
Gross motor function
|
47.6 score on a scale
Standard Deviation 15.1
|
47.5 score on a scale
Standard Deviation 14.5
|
|
Infant Development
Fine motor function
|
50 score on a scale
Standard Deviation 9.4
|
48.5 score on a scale
Standard Deviation 9.5
|
|
Infant Development
Problem-solving
|
42 score on a scale
Standard Deviation 12.9
|
41.1 score on a scale
Standard Deviation 13.8
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place