PostpartumMOMSPostpartumNCT06899737
Monitoring and Outreach for Maternal Safety Postpartum
A study testing MOMS Postpartum Course in people with Postpartum and Women, run by KDH Research & Communication at 1 site in United States.
Trial summary
Two arm study, intervention and control, to explore the impact of an online training program to help community health workers (CHWs) conduct effective outreach to support postpartum mothers, particularly those at higher risk for complications. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Women, Community Health Workers
- What is being tested?
- MOMS Postpartum Course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to 30 Apr 2025
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years old.
- Must self-identify as a community health worker (CHW).
- Must live in the United States.
- Must have six months of field experience. KDHRC defines "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events.
- Must be an active CHW. KDHRC defines "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
- Must have Internet access either at home or at work to access the lessons and/or online surveys.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
KDH Research & Communication
Atlanta, Georgia, 30309
About this study
Two arm study, intervention and control, to explore the impact of an online training program to help community health workers (CHWs) conduct effective outreach to support postpartum mothers, particularly those at higher risk for complications.
Read the detailed description
The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the MOMS Postpartum course and explore the following research question: To what extent does exposure to the MOMS Postpartum course increase CHWs' knowledge, skills, attitudes/beliefs, self-efficacy, and intentions to provide support to postpartum mothers?
MOMS Postpartum course is set in context of imperative need of assisting postpartum mothers in the U.S. and working with CHWs after pregnancy to have better maternal outcomes, particularly among high-risk mothers. Researchers worked with subject matter experts, CHWs, and the intended audience to ensure the MOMS Postpartum course reflects the specific needs of postpartum mothers; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to conduct outreach with high-risk postpartum mothers. MOMS Postpartum course will provide an effective, low-cost, evidence-based, professional development curriculum to train CHWs to provide support to postpartum mothers and fill a gap in care.
The Principal Investigator (PI), with input from the subject matter experts and CHWs, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDHRC Institutional Review Board before the evaluation launch.
Investigators will recruit participants through evaluation partners who will disseminate the study information to CHWs via electronic notifications and flyers. Evaluation partners include CHW Association of Rochester, Center for Health Innovation, and other CHW organizations. The notifications and flyers provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.
After consent and enrollment into the study, CHWs will complete a pretest survey and be randomly assigned to the intervention or control group. The intervention group will be exposed to MOMS Postpartum course and will complete an online posttest survey after completing the online modules. The control group participants will not be exposed to the MOMS Postpartum course and will complete a posttest one week after completing the pretest. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
The investigators will download and export the data from Alchemer into an encrypted Excel file and import the raw data into STATA. The investigators will match the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of MOMS Postpartum course exposure on changes in CHWs' knowledge, skills, attitudes/beliefs, perceived self-efficacy, and intentions to conduct outreach to postpartum mothers.
The initial feasibility criterion is: Statistically significant (p<0.05) and positive relationship between exposure to MOMS Postpartum course and increased knowledge among the intervention group in comparison to the control group.
- Conditions
- Postpartum, Women, Community Health Workers, Knowledge, High-risk, Self Efficacy
- Being tested
- MOMS Postpartum Course
- Keywords
- Community health workers, Postpartum, Support for high risk postpartum women, Women
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOMS Postpartum CourseOther
Online professional development training for CHWs on outreach and support for high-risk postpartum mothers
| Study group | Role | What they receive |
|---|---|---|
| Treatment: MOMS Postpartum course | Experimental | Community health workers (CHWs) in the treatment group will complete the MOMS Postpartum course online training program. They will engage with the training materials, apply learned concepts, and complete pretest and posttest assessments to measure changes in their knowledge, skills, attitudes, intentions and self-efficacy. Receives: Other: MOMS Postpartum Course |
| Control | No intervention | Community health workers (CHWs) in the control group will not receive access to the MOMS Postpartum course training during the study period. Their will continue their usual work without the additional training while also completing pretest and posttest assessments to allow for comparison with the treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Pretest Score
Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge.
Measured: Pretest (Baseline)
Knowledge Posttest Score
Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge.
Measured: Posttest (1 week after baseline)
Skills Pretest Score
Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers
Measured: Pretest (Baseline)
Skills Posttest Score
Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers
Measured: Posttest (1 week after baseline)
Self-efficacy Pretest Score
Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) to measure CHWs' beliefs that they can effectively support postpartum mothers
Measured: Pretest (Baseline)
Self-efficacy Posttest Score
Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, to measure CHWs' beliefs that they can effectively support postpartum mothers
Measured: Posttest (1 week after baseline)
Attitudes Pretest Score
Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers
Measured: Pretest (Baseline)
Attitudes Posttest Score
Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers
Measured: Posttest (1 week after baseline)
Intentions Pretest Score
Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers
Measured: Pretest (Baseline)
Intentions Posttest Score
Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers
Measured: Posttest (1 week after baseline)
Secondary outcomes (1)
Satisfaction at Posttest
Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree), with a higher score being a better outcome, to measure CHWs' satisfaction with the course, interactive experiences, and offline resources and measure the extent to which CHWs would recommend the course
Measured: Posttest (1 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start5 Mar 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
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.
- Other trials for PostpartumStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Community health workers will be randomly assigned to either the treatment group, which will complete the MOMS Postpartum course, or the control group, which will not receive the training during the study period. Both groups will complete pretest and posttest assessments.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- KDH Research & Communication
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Dexter L Cooper, MPH, Principal investigator, KDH Research & Communication
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899737
- Sponsor's protocol ID
- 2025-02-03
- Other IDs
- 1R43MD019206-01
- Acronym
- MOMSPostpartum
- Status last verified
- Jul 2025
- First submitted
- 20 Mar 2025
- Last updated
- 23 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Outreach for Maternal Safety Postpartum
- ClinicalTrials.gov ID
- NCT06899737
- Acronym / sponsor ID
- MOMSPostpartum / 2025-02-03
- Conditions
- Postpartum, Women, Community Health Workers, Knowledge, High-risk, Self Efficacy
- Keywords
- Community health workers, Postpartum, Support for high risk postpartum women, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- KDH Research & CommunicationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two arm study, intervention and control, to explore the impact of an online training program to help community health workers (CHWs) conduct effective outreach to support postpartum mothers, particularly those at higher risk for complications.
Detailed description
The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the MOMS Postpartum course and explore the following research question: To what extent does exposure to the MOMS Postpartum course increase CHWs' knowledge, skills, attitudes/beliefs, self-efficacy, and intentions to provide support to postpartum mothers?
MOMS Postpartum course is set in context of imperative need of assisting postpartum mothers in the U.S. and working with CHWs after pregnancy to have better maternal outcomes, particularly among high-risk mothers. Researchers worked with subject matter experts, CHWs, and the intended audience to ensure the MOMS Postpartum course reflects the specific needs of postpartum mothers; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to conduct outreach with high-risk postpartum mothers. MOMS Postpartum course will provide an effective, low-cost, evidence-based, professional development curriculum to train CHWs to provide support to postpartum mothers and fill a gap in care.
The Principal Investigator (PI), with input from the subject matter experts and CHWs, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDHRC Institutional Review Board before the evaluation launch.
Investigators will recruit participants through evaluation partners who will disseminate the study information to CHWs via electronic notifications and flyers. Evaluation partners include CHW Association of Rochester, Center for Health Innovation, and other CHW organizations. The notifications and flyers provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.
After consent and enrollment into the study, CHWs will complete a pretest survey and be randomly assigned to the intervention or control group. The intervention group will be exposed to MOMS Postpartum course and will complete an online posttest survey after completing the online modules. The control group participants will not be exposed to the MOMS Postpartum course and will complete a posttest one week after completing the pretest. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
The investigators will download and export the data from Alchemer into an encrypted Excel file and import the raw data into STATA. The investigators will match the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of MOMS Postpartum course exposure on changes in CHWs' knowledge, skills, attitudes/beliefs, perceived self-efficacy, and intentions to conduct outreach to postpartum mothers.
The initial feasibility criterion is: Statistically significant (p<0.05) and positive relationship between exposure to MOMS Postpartum course and increased knowledge among the intervention group in comparison to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Community health workers will be randomly assigned to either the treatment group, which will complete the MOMS Postpartum course, or the control group, which will not receive the training during the study period. Both groups will complete pretest and posttest assessments.
| Arm | Type | Receives |
|---|---|---|
| Treatment: MOMS Postpartum course | Experimental | Other: MOMS Postpartum CourseCommunity health workers (CHWs) in the treatment group will complete the MOMS Postpartum course online training program. They will engage with the training materials, apply learned concepts, and complete pretest and posttest assessments to measure changes in their knowledge, skills, attitudes, intentions and self-efficacy. |
| Control | No intervention | –Community health workers (CHWs) in the control group will not receive access to the MOMS Postpartum course training during the study period. Their will continue their usual work without the additional training while also completing pretest and posttest assessments to allow for comparison with the treatment group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be at least 18 years old.
- Must self-identify as a community health worker (CHW).
- Must live in the United States.
- Must have six months of field experience. KDHRC defines "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events.
- Must be an active CHW. KDHRC defines "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| MOMS Postpartum CourseOnline professional development training for CHWs on outreach and support for high-risk postpartum mothers | Other | Treatment: MOMS Postpartum course |
Primary outcome
Knowledge Pretest Score
Time frame: Pretest (Baseline)
Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge.
Knowledge Posttest Score
Time frame: Posttest (1 week after baseline)
Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge.
Skills Pretest Score
Time frame: Pretest (Baseline)
Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers
Skills Posttest Score
Time frame: Posttest (1 week after baseline)
Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers
Self-efficacy Pretest Score
Time frame: Pretest (Baseline)
Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) to measure CHWs' beliefs that they can effectively support postpartum mothers
Self-efficacy Posttest Score
Time frame: Posttest (1 week after baseline)
Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, to measure CHWs' beliefs that they can effectively support postpartum mothers
Attitudes Pretest Score
Time frame: Pretest (Baseline)
Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers
Attitudes Posttest Score
Time frame: Posttest (1 week after baseline)
Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers
Intentions Pretest Score
Time frame: Pretest (Baseline)
Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers
Intentions Posttest Score
Time frame: Posttest (1 week after baseline)
Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers
1 secondary outcome
Satisfaction at Posttest
Time frame: Posttest (1 weeks after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dexter L Cooper, MPH principal investigator
KDH Research & Communication
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOMS Postpartum Course in people with Postpartum and Women, run by KDH Research & Communication 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 6 inclusion and 1 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 23 Jul 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 23 Jul 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?
Knowledge Pretest Score (time frame: Pretest (Baseline)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2025.