Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test whether a web-based (eHealth) exercise intervention for new moms at increased risk for postpartum depression increases physical activity and decreases postpartum depression symptoms.
Postpartum depression is a debilitating and costly condition that is associated with significant health consequences for mothers and children. Counseling for prevention of postpartum depression is currently recommended in women at high risk of postpartum depression; however, there is a shortage of mental health care providers. There is a need for effective interventions to prevent postpartum depression that can be easily integrated into health care systems, yet do not involve intense health care system resources. eHealth interventions are promising in this regard.
Strong evidence suggests physical activity can reduce depression risk. This study will assess the effectiveness of an eHealth exercise intervention tailored to postpartum mothers for increasing physical activity levels and improving depressive symptoms in women at increased risk of postpartum depression. This intervention addresses several identified barriers to physical activity in postpartum women. The study will randomize 200 women to receive an eHealth exercise intervention for postpartum women or usual postpartum care. Device-based physical activity and depressive symptoms will be measured at 3 and 6 months after randomization.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise intervention | Behavioral | eHealth exercise intervention for postpartum women at increased risk of depression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression Symptoms | 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. | 3 months |
| Device-Measured Physical Activity | Actigraph-measured minutes of moderate/vigorous physical activity | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Physical Activity | Self-reported moderate/vigorous physical activity | 3 months |
| Device-measured Physical Activity | Actigraph-measured minutes of moderate/vigorous physical |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep | 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. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lyndsay Avalos, PhD, MPH | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Research | Oakland | California | 94612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39470705 | Derived | Ramsey M, Oberman N, Quesenberry CP Jr, Kurtovich E, Gomez Chavez L, Chess A, Brown SD, Albright CL, Bhalala M, Badon SE, Avalos LA. A Tailored Postpartum eHealth Physical Activity Intervention for Individuals at High Risk of Postpartum Depression-the POstpartum Wellness Study (POW): Protocol and Data Overview for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 29;13:e56882. doi: 10.2196/56882. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3-month Follow up |
|
| |||||||||||||||||||||
| 6-month Follow up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression Symptoms | 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. | After multiple imputation | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
6 months of follow up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lyndsay Avalos | Kaiser Permanente | 5108210300 | lyndsay.a.avalos@kp.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2020 | Jul 29, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
The Investigators and programmers/analysts will be blinded to the intervention assignment. The participants, project manager and research assistant will not be masked.
| 6 months |
| Depressive Symptoms | 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. | 6 months |
| Self-reported Physical Activity | Self-reported moderate/vigorous physical activity | 6 months |
| Mother-infant Bonding | 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. | 3 months |
| Anxiety | 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. | 3 months |
| Stress | 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. | 3 months |
| Infant Development | 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. | At 12 months old |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Months postpartum | Mean | Standard Deviation | months |
|
| Number of children at home | Count of Participants | Participants |
|
| Depressive symptons | 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. | Mean | Standard Deviation | score on a scale |
|
| Physical activity level prior to pregnancy | Measured using the Stanford Leisure-Time Activity Categorical Item (L-Cat) modified to reflect the year before pregnancy | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Primary | Device-Measured Physical Activity | Actigraph-measured minutes of moderate/vigorous physical activity | After multiple imputation | Posted | Mean | Standard Deviation | minutes per day | 3 months |
|
|
|
|
| Secondary | Self-reported Physical Activity | Self-reported moderate/vigorous physical activity | Intent to treat analysis with multiple imputation | Posted | Mean | Standard Deviation | MET-hours per week | 3 months |
|
|
|
|
| Secondary | Device-measured Physical Activity | Actigraph-measured minutes of moderate/vigorous physical | Intent to treat analysis with multiple imputation | Posted | Mean | Standard Deviation | minutes per day | 6 months |
|
|
|
|
| Secondary | Depressive Symptoms | 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. | Intent to treat analysis with multiple imputation | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| Secondary | Self-reported Physical Activity | Self-reported moderate/vigorous physical activity | Intent to treat analysis with multiple imputation | Posted | Mean | Standard Deviation | MET-hours per week | 6 months |
|
|
|
|
| Other Pre-specified | Sleep | 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. | Intent to treat analysis with multiple imputation | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
|
| Other Pre-specified | Mother-infant Bonding | 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. | Intent to treat analysis with multiple imputation | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
|
| Other Pre-specified | Anxiety | 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. | Intent to treat analysis with multiple imputation | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
|
| Other Pre-specified | Stress | 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. | Intent to treat analysis with multiple imputation | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
|
| Other Pre-specified | Infant Development | 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. | Intent to treat analysis with multiple imputation | Posted | Mean | Standard Deviation | score on a scale | At 12 months old |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. | 0 | 49 | 0 | 49 | 0 | 49 |
Not provided
Not provided
Not provided
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| Fine motor function |
|
| Problem-solving |
|
| Personal-social skills |
|