NCT07901439|Not Yet Recruiting
Generations for Heart Health
3-2-GenHealth: A Familism-Informed Pilot to Engage Mothers and Grandmothers in Cardiovascular Research and Prevention
Loading search results
3-2-GenHealth: A Familism-Informed Pilot to Engage Mothers and Grandmothers in Cardiovascular Research and Prevention
Sponsor study identifier
Secondary identifiers
NIH
interventional
60
1 country
2
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2026
Actual (reported)October 28, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Fitbit Average Daily Wear Time
Average number of minutes worn per day
Week 2, Week 3
Fitbit Proportion of Wear Time
Week 2, Week 3
Daily Moderate-to-Vigorous Physical Activity (MVPA)
Week 2, Week 3
Engagement in Intervention Components
Up to Week 4
Fitbit Average Daily Wear Time during 1-Week Post-Intervention
Week 4
Attrition
Up to Week 3
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.
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.
Will be used to provide objectively measured data on daily steps and other physical activity metrics over the study period.
Self-affirmation-based text messages.
NYU Langone Health
Long Island City, New York, 11101, United States
NYU Langone Health
New York, New York, 10016, United States
Robin Ortiz, MD, MS
NYU Langone Health
Elaine De Leon, MD
NYU Langone Health
First Submitted
October 14, 2026
First Posted
October 28, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2027
EstimatedEarly Intervention to Promote Cardiovascular Health of Mothers and Children
Interpersonal Relationships Intervention and Cardiovascular Health
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: