Postpartum DepressionPOWNCT04414696
Postpartum Wellness
A study testing Exercise intervention in people with Postpartum Depression, run by Kaiser Permanente at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 1 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- KPNC member between 2 and 6 months postpartum
- Current PHQ-8 score between 10-20 and no current depression diagnosis
- Delivered baby in KPNC
- English-speaking
- Own a smartphone, computer, or TV with internet access
- Free of a heart condition and a physician recommending medically supervised physical activity
- Body Mass Index (BMI) between 18.5 and 40 (kg/m2)
- A baby weighing between 11-22 lbs
Who cannot join
- Engaged in regular, moderate or vigorous physical activity >90 minutes or more per week
- Pregnant or planning to become pregnant in the ensuing three months
- A baby with chronic illness/disorder(s) that prevent participant from holding or lifting him/her
- Chest pain during physical activity, or has had chest pain within the prior month
- Taking medication for hypertension or a heart condition
- Tendency to fall due to syncope or dizziness
- Orthopedic problems that might be aggravated by physical activity
- Has exercise-induced asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Postpartum Depression: Exercise as Medicine
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.
Read the detailed description
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.
- Conditions
- Postpartum Depression
- Being tested
- Exercise intervention
- Keywords
- Exercise, Postpartum Depression, Physical activity, eHealth intervention
- Medical subject headings
- Depression, Postpartum, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
eHealth exercise intervention for postpartum women at increased risk of depression
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Device-Measured Physical Activity
Actigraph-measured minutes of moderate/vigorous physical activity
Measured: 3 months
Secondary outcomes (4)
Self-reported Physical Activity
Self-reported moderate/vigorous physical activity
Measured: 3 months
Device-measured Physical Activity
Actigraph-measured minutes of moderate/vigorous physical
Measured: 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.
Measured: 6 months
Self-reported Physical Activity
Self-reported moderate/vigorous physical activity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start19 Nov 2020
- Primary completion13 Dec 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyndsay Avalos, PhD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414696
- Sponsor's protocol ID
- 1548855
- Acronym
- POW
- Status last verified
- Nov 2023
- First submitted
- 1 Jun 2020
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39470705
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Postpartum Depression: Exercise as Medicine
- ClinicalTrials.gov ID
- NCT04414696
- Acronym / sponsor ID
- POW / 1548855
- Conditions
- Postpartum Depression
- Keywords
- Exercise, Postpartum Depression, Physical activity, eHealth intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Exercise interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- KPNC member between 2 and 6 months postpartum
- Current PHQ-8 score between 10-20 and no current depression diagnosis
- Delivered baby in KPNC
- English-speaking
- Own a smartphone, computer, or TV with internet access
Key exclusion criteria (8 listed)
- Engaged in regular, moderate or vigorous physical activity >90 minutes or more per week
- Pregnant or planning to become pregnant in the ensuing three months
- A baby with chronic illness/disorder(s) that prevent participant from holding or lifting him/her
- Chest pain during physical activity, or has had chest pain within the prior month
- Taking medication for hypertension or a heart condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventioneHealth exercise intervention for postpartum women at increased risk of depression | Behavioural | Intervention |
Primary outcome
Depression Symptoms
Time frame: 3 months
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.
Device-Measured Physical Activity
Time frame: 3 months
Actigraph-measured minutes of moderate/vigorous physical activity
4 secondary outcomes
Self-reported Physical Activity
Time frame: 3 months
Device-measured Physical Activity
Time frame: 6 months
Depressive Symptoms
Time frame: 6 months
Self-reported Physical Activity
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39470705Ramsey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndsay Avalos, PhD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Postpartum Depression, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Symptoms (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.