Cardiovascular DiseasesNCT06796075
Identifying Strategies to Reduce Cardiovascular Risk Among Mothers of Young Children
A study testing Mom♥Health in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
Trial summary
This single-site research study will pilot-test a context-specific cardiovascular disease (CVD) risk prevention program, Mom♥Health, using two childhood centers at Family Health Centers (FHC) at NYU Langone as platforms for maternal engagement. Read more about this study
- Who is it for?
- Ages 21 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Mom♥Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identifies as a woman
- Is a primary caregiver of child(ren) ≤ 5 years (biological, adopted, fostered) and the child(ren) attends one of the designated childhood centers at FHC at NYU Langone;
- Is between 21-49 years of age
- Is English/Spanish/Mandarin speaking
- Has the capacity and willingness to provide consent
Who cannot join
- Significant cognitive impairment (evident during screening)
- Current participation in another behavioral clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
This single-site research study will pilot-test a context-specific cardiovascular disease (CVD) risk prevention program, Mom♥Health, using two childhood centers at Family Health Centers (FHC) at NYU Langone as platforms for maternal engagement.
- Conditions
- Cardiovascular Diseases
- Being tested
- Mom♥Health
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mom♥HealthBehavioural
12-week intervention involving 1) weekly phone calls to mothers regarding education and counseling related to heart healthy lifestyle, as well as strategies for stress reduction; 2) referral to clinical care for identified needs (e.g., elevated blood pressure); and 3) referral to available social resources (e.g., food pantry for identified food insecurity).
| Study group | Role | What they receive |
|---|---|---|
| Socially Vulnerable Mothers | Experimental | Socially vulnerable mothers of young children, whose children attend formal childcare, will receive telephone-delivered programs over 12 weeks. They will also attend a 6 weeks post-intervention follow-up assessment. Receives: Behavioral: Mom♥Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Complete Intervention Program
Measure of intervention feasibility.
Measured: Week 12
Percentage of Participants who Schedule Clinic/Social Services Appointment for Identified Needs
Measure of intervention feasibility; measured among participants with an identified need.
Measured: Week 18
Client Satisfaction Questionnaire-8 Score
8-item questionnaire related to satisfaction with intervention/service experience. Each item is rated on a Likert scale from 1-4; the total score is the sum of responses and ranges from 8 to 32, with the higher number indicating greater satisfaction.
Measured: Week 18
Percentage of Eligible Mothers who Consent to Enroll
Measure of intervention acceptability.
Measured: Baseline
Secondary outcomes (18)
Perceived Stress Scale (PSS-10) Score
The PSS-10 is a 10-item assessment of the degree to which respondents feel that life was overwhelming, uncontrollable, and unpredictable over the last month. Items are rated on a 5-point scale. PSS-10 scores range from 0-40, with higher scores indicating greater perceived stress.
Measured: Baseline
Perceived Stress Scale (PSS-10) Score
The PSS-10 is a 10-item assessment of the degree to which respondents feel that life was overwhelming, uncontrollable, and unpredictable over the last month. Items are rated on a 5-point scale. PSS-10 scores range from 0-40, with higher scores indicating greater perceived stress.
Measured: Week 12
Perceived Stress Scale (PSS-10) Score
The PSS-10 is a 10-item assessment of the degree to which respondents feel that life was overwhelming, uncontrollable, and unpredictable over the last month. Items are rated on a 5-point scale. PSS-10 scores range from 0-40, with higher scores indicating greater perceived stress.
Measured: Week 18
Patient Health Questionnaire (PHQ-8) Score
The PHQ-8 is an 8-item measure of depressive symptoms during the prior two weeks. Each item has a response scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-24; higher scores indicate greater levels of depression.
Measured: Baseline
Patient Health Questionnaire (PHQ-8) Score
The PHQ-8 is an 8-item measure of depressive symptoms during the prior two weeks. Each item has a response scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-24; higher scores indicate greater levels of depression.
Measured: Week 12
Patient Health Questionnaire (PHQ-8) Score
The PHQ-8 is an 8-item measure of depressive symptoms during the prior two weeks. Each item has a response scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-24; higher scores indicate greater levels of depression.
Measured: Week 18
Mediterranean Eating Pattern for Americans (MEPA) Score
The Mediterranean Eating Pattern for Americans (MEPA) is a 16-item measure of how well a person's diet adheres to the Mediterranean diet. The MEPA score is calculated by assigning a score of 0 or 1 to each item on the MEPA screener. Scores range from 0 to 16; higher scores indicate greater adherence to the Mediterranean diet.
Measured: Baseline
Mediterranean Eating Pattern for Americans (MEPA) Score
The Mediterranean Eating Pattern for Americans (MEPA) is a 16-item measure of how well a person's diet adheres to the Mediterranean diet. The MEPA score is calculated by assigning a score of 0 or 1 to each item on the MEPA screener. Scores range from 0 to 16; higher scores indicate greater adherence to the Mediterranean diet.
Measured: Week 12
Mediterranean Eating Pattern for Americans (MEPA) Score
The Mediterranean Eating Pattern for Americans (MEPA) is a 16-item measure of how well a person's diet adheres to the Mediterranean diet. The MEPA score is calculated by assigning a score of 0 or 1 to each item on the MEPA screener. Scores range from 0 to 16; higher scores indicate greater adherence to the Mediterranean diet.
Measured: Week 18
International Physical Activity Questionnaire (IPAQ) Score
The IPAQ is an assessment how much time participants spent being physically active in the last 7 days. The score is calculated expressed as metabolic equivalent of task (MET)-minutes per week. Higher scores indicate greater physical activity.
Measured: Baseline
International Physical Activity Questionnaire (IPAQ) Score
The IPAQ is an assessment how much time participants spent being physically active in the last 7 days. The score is calculated expressed as metabolic equivalent of task (MET)-minutes per week. Higher scores indicate greater physical activity.
Measured: Week 12
International Physical Activity Questionnaire (IPAQ) Score
The IPAQ is an assessment how much time participants spent being physically active in the last 7 days. The score is calculated expressed as metabolic equivalent of task (MET)-minutes per week. Higher scores indicate greater physical activity.
Measured: Week 18
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score
The PROMIS-Sleep Disturbance subscale is an 8-item questionnaire designed to assess an individual's perception of their sleep disturbances. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 8 to 40, with higher scores indicating more severe sleep disturbance.
Measured: Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score
The PROMIS-Sleep Disturbance subscale is an 8-item questionnaire designed to assess an individual's perception of their sleep disturbances. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 8 to 40, with higher scores indicating more severe sleep disturbance.
Measured: Week 12
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score
The PROMIS-Sleep Disturbance subscale is an 8-item questionnaire designed to assess an individual's perception of their sleep disturbances. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 8 to 40, with higher scores indicating more severe sleep disturbance.
Measured: Week 18
Mean Blood Pressure
At each time point, 3 BP readings separated by one minute will be obtained. The 3 BP readings will be averaged to obtain the mean study BP.
Measured: Baseline
Mean Blood Pressure
At each time point, 3 BP readings separated by one minute will be obtained. The 3 BP readings will be averaged to obtain the mean study BP.
Measured: Week 12
Mean Blood Pressure
At each time point, 3 BP readings separated by one minute will be obtained. The 3 BP readings will be averaged to obtain the mean study BP.
Measured: Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start28 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milla Arabadjian, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796075
- Sponsor's protocol ID
- 24-01959
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Milla.arabadjian@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Strategies to Reduce Cardiovascular Risk Among Mothers of Young Children
- ClinicalTrials.gov ID
- NCT06796075
- Acronym / sponsor ID
- 24-01959
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-site research study will pilot-test a context-specific cardiovascular disease (CVD) risk prevention program, Mom♥Health, using two childhood centers at Family Health Centers (FHC) at NYU Langone as platforms for maternal engagement.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Socially Vulnerable Mothers | Experimental | Behavioral: Mom♥HealthSocially vulnerable mothers of young children, whose children attend formal childcare, will receive telephone-delivered programs over 12 weeks. They will also attend a 6 weeks post-intervention follow-up assessment. |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Self-identifies as a woman
- Is a primary caregiver of child(ren) ≤ 5 years (biological, adopted, fostered) and the child(ren) attends one of the designated childhood centers at FHC at NYU Langone;
- Is between 21-49 years of age
- Is English/Spanish/Mandarin speaking
- Has the capacity and willingness to provide consent
Key exclusion criteria (2 listed)
- Significant cognitive impairment (evident during screening)
- Current participation in another behavioral clinical trial
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 |
|---|---|---|
| Mom♥Health12-week intervention involving 1) weekly phone calls to mothers regarding education and counseling related to heart healthy lifestyle, as well as strategies for stress reduction; 2) referral to clinical care for identified needs (e.g., elevated blood pressure); and 3) referral to available social resources (e.g., food pantry for identified food insecurity). | Behavioural | Socially Vulnerable Mothers |
Primary outcome
Percentage of Participants who Complete Intervention Program
Time frame: Week 12
Measure of intervention feasibility.
Percentage of Participants who Schedule Clinic/Social Services Appointment for Identified Needs
Time frame: Week 18
Measure of intervention feasibility; measured among participants with an identified need.
Client Satisfaction Questionnaire-8 Score
Time frame: Week 18
8-item questionnaire related to satisfaction with intervention/service experience. Each item is rated on a Likert scale from 1-4; the total score is the sum of responses and ranges from 8 to 32, with the higher number indicating greater satisfaction.
Percentage of Eligible Mothers who Consent to Enroll
Time frame: Baseline
Measure of intervention acceptability.
18 secondary outcomes
Perceived Stress Scale (PSS-10) Score
Time frame: Baseline
Perceived Stress Scale (PSS-10) Score
Time frame: Week 12
Perceived Stress Scale (PSS-10) Score
Time frame: Week 18
Patient Health Questionnaire (PHQ-8) Score
Time frame: Baseline
Patient Health Questionnaire (PHQ-8) Score
Time frame: Week 12
Patient Health Questionnaire (PHQ-8) Score
Time frame: Week 18
Mediterranean Eating Pattern for Americans (MEPA) Score
Time frame: Baseline
Mediterranean Eating Pattern for Americans (MEPA) Score
Time frame: Week 12
Mediterranean Eating Pattern for Americans (MEPA) Score
Time frame: Week 18
International Physical Activity Questionnaire (IPAQ) Score
Time frame: Baseline
International Physical Activity Questionnaire (IPAQ) Score
Time frame: Week 12
International Physical Activity Questionnaire (IPAQ) Score
Time frame: Week 18
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score
Time frame: Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score
Time frame: Week 12
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score
Time frame: Week 18
Mean Blood Pressure
Time frame: Baseline
Mean Blood Pressure
Time frame: Week 12
Mean Blood Pressure
Time frame: Week 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Milla.arabadjian@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Milla Arabadjian principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mom♥Health in people with Cardiovascular Diseases, run by NYU Langone Health 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants who Complete Intervention Program (time frame: Week 12). The study lists 4 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 14 Aug 2026.