Cardiovascular HealthNCT07901439
Generations for Heart Health
A study testing Activity Tracker and Text Messages in people with Cardiovascular Health, run by NYU Langone Health at 2 sites in United States.
Trial summary
Heart disease is the leading cause of death for women in the United States, and many women find it hard to prioritize their own health while caring for family. This randomized control trial pilot aims to test whether linking heart-healthy habits to a woman's role as a mother or grandmother can increase physical… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Activity Tracker and Text Messages
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2027
- 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 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mother or grandmother (>= 18 years) of a child aged 0-13 years
- Able to read and understand English or Spanish
- Engages in less than 150 minutes (total) of moderate-to-vigorous physical activity (MVPA) per week (self-reported) at baseline
- Owns a mobile phone capable of receiving text messages
- Able and willing to use a wearable activity tracker
Who cannot join
- Known medical condition(s) that significantly limit(s) safe participation in light-moderate physical activity (e.g., symptomatic cardiovascular disease, history of heart attack, recent major surgery)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
NYU Langone Health
Long Island City, New York, 11101
NYU Langone Health
New York, New York, 10016
About this study
Official title: 3-2-GenHealth: A Familism-Informed Pilot to Engage Mothers and Grandmothers in Cardiovascular Research and Prevention
Heart disease is the leading cause of death for women in the United States, and many women find it hard to prioritize their own health while caring for family. This randomized control trial pilot aims to test whether linking heart-healthy habits to a woman's role as a mother or grandmother can increase physical activity and improve other heart-healthy behaviors. The study will enroll mothers and grandmothers of young children, who may join as a mother-grandmother pair or on their own. All participants will complete a baseline questionnaire (self-reported cardiovascular health including physical activity), followed by 4 weeks of wearing an activity tracker (such as a Fitbit) and a post-study period questionnaire (repeating baseline measures). After the first baseline week, participants will be randomly assigned, with pairs assigned together, to an intervention or comparison group. The intervention group will complete a short online writing activity about their caregiving role and personal values, then receive 2 weeks of daily text messages linking their health and physical activity to the health of their children and family, followed by a fourth observational week where no messaging is delivered. The comparison group will also wear the tracker for 4 weeks, but will receive 2 weeks of general daily messages (a greeting + device use reminder). The main question is whether the intervention group is more engaged in the study activities during the text message period.
- Conditions
- Cardiovascular Health
- Being tested
- Activity Tracker, Text Messages
- Keywords
- mHealth, Cardiovascular Health, Wearable Device, Women's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity TrackerDevice
Will be used to provide objectively measured data on daily steps and other physical activity metrics over the study period.
Text MessagesBehavioural
Self-affirmation-based text messages.
| Study group | Role | What they receive |
|---|---|---|
| Activity Tracker + Self-affirmation task + Familism-based Text Messages | Experimental | Women enrolled and assigned to the intervention arm will wear an activity tracker, then complete a self-affirmation task and receive familism-based text-messages to encourage physical activity and wearable use. Receives: Device: Activity Tracker; Behavioral: Text Messages |
| Activity Tracker + Text Messages | Active comparator | Women enrolled and assigned to the comparison arm will wear an activity tracker, and receive a text-message greeting with an encouragement for wearable use. Receives: Device: Activity Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitbit Average Daily Wear Time
Average number of minutes worn per day
Measured: Week 2, Week 3
Secondary outcomes (5)
Fitbit Proportion of Wear Time
Proportion of days worn of intended study period.
Measured: Week 2, Week 3
Daily Moderate-to-Vigorous Physical Activity (MVPA)
Average daily MVPA by wearable device and by self-reported IPAQ-SF.
Measured: Week 2, Week 3
Engagement in Intervention Components
Composite measure of the proportion of participants completing self-affirmation task; self-reported proportion of text-messages read; text-message satisfaction.
Measured: Up to Week 4
Fitbit Average Daily Wear Time during 1-Week Post-Intervention
Average number of minutes worn per day.
Measured: Week 4
Attrition
Proportion of Participants who opt-out of text-messages.
Measured: Up to Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Robin Ortiz, MD, MS, Principal investigator, NYU Langone HealthElaine De Leon, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901439
- Sponsor's protocol ID
- 26-00306
- Other IDs
- UM1TR005769
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 28 Oct 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: Robin Ortiz, MD, MS via email at robin.ortiz@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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-2-GenHealth: A Familism-Informed Pilot to Engage Mothers and Grandmothers in Cardiovascular Research and Prevention
- ClinicalTrials.gov ID
- NCT07901439
- Acronym / sponsor ID
- 26-00306
- Conditions
- Cardiovascular Health
- Keywords
- mHealth, Cardiovascular Health, Wearable Device, Women's health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Oct 2026 (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.
Heart disease is the leading cause of death for women in the United States, and many women find it hard to prioritize their own health while caring for family. This randomized control trial pilot aims to test whether linking heart-healthy habits to a woman's role as a mother or grandmother can increase physical activity and improve other heart-healthy behaviors. The study will enroll mothers and grandmothers of young children, who may join as a mother-grandmother pair or on their own. All participants will complete a baseline questionnaire (self-reported cardiovascular health including physical activity), followed by 4 weeks of wearing an activity tracker (such as a Fitbit) and a post-study period questionnaire (repeating baseline measures). After the first baseline week, participants will be randomly assigned, with pairs assigned together, to an intervention or comparison group. The intervention group will complete a short online writing activity about their caregiving role and personal values, then receive 2 weeks of daily text messages linking their health and physical activity to the health of their children and family, followed by a fourth observational week where no messaging is delivered. The comparison group will also wear the tracker for 4 weeks, but will receive 2 weeks of general daily messages (a greeting + device use reminder). The main question is whether the intervention group is more engaged in the study activities during the text message period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity Tracker + Self-affirmation task + Familism-based Text Messages | Experimental | Device: Activity Tracker, Behavioral: Text MessagesWomen enrolled and assigned to the intervention arm will wear an activity tracker, then complete a self-affirmation task and receive familism-based text-messages to encourage physical activity and wearable use. |
| Activity Tracker + Text Messages | Active comparator | Device: Activity TrackerWomen enrolled and assigned to the comparison arm will wear an activity tracker, and receive a text-message greeting with an encouragement for wearable use. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mother or grandmother (>= 18 years) of a child aged 0-13 years
- Able to read and understand English or Spanish
- Engages in less than 150 minutes (total) of moderate-to-vigorous physical activity (MVPA) per week (self-reported) at baseline
- Owns a mobile phone capable of receiving text messages
- Able and willing to use a wearable activity tracker
Key exclusion criteria (1 listed)
- Known medical condition(s) that significantly limit(s) safe participation in light-moderate physical activity (e.g., symptomatic cardiovascular disease, history of heart attack, recent major surgery)
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 |
|---|---|---|
| Activity TrackerWill be used to provide objectively measured data on daily steps and other physical activity metrics over the study period. | Device | Activity Tracker + Self-affirmation task + Familism-based Text Messages, Activity Tracker + Text Messages |
| Text MessagesSelf-affirmation-based text messages. | Behavioural | Activity Tracker + Self-affirmation task + Familism-based Text Messages |
Primary outcome
Fitbit Average Daily Wear Time
Time frame: Week 2, Week 3
Average number of minutes worn per day
5 secondary outcomes
Fitbit Proportion of Wear Time
Time frame: Week 2, Week 3
Daily Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: Week 2, Week 3
Engagement in Intervention Components
Time frame: Up to Week 4
Fitbit Average Daily Wear Time during 1-Week Post-Intervention
Time frame: Week 4
Attrition
Time frame: Up to Week 3
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 28 Oct 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: Robin Ortiz, MD, MS via email at robin.ortiz@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.
Robin Ortiz, MD, MS principal investigator
NYU Langone Health
Elaine De Leon, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Tracker and Text Messages in people with Cardiovascular Health, run by NYU Langone Health at 2 sites 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 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Robin Ortiz, MD, MS (646-965-3864, Robin.Ortiz@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitbit Average Daily Wear Time (time frame: Week 2, Week 3). 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 28 Oct 2026.