Cardiovascular Health
Conditions
Keywords
mHealth, Cardiovascular Health, Wearable Device, Women's health
Brief 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 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.
Interventions
DEVICEActivity Tracker
Will be used to provide objectively measured data on daily steps and other physical activity metrics over the study period.
BEHAVIORALText Messages
Self-affirmation-based text messages.
Sponsors
NYU Langone Health
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
• 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fitbit Average Daily Wear Time | Week 2, Week 3 | Average number of minutes worn per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fitbit Proportion of Wear Time | Week 2, Week 3 | Proportion of days worn of intended study period. |
| Daily Moderate-to-Vigorous Physical Activity (MVPA) | Week 2, Week 3 | Average daily MVPA by wearable device and by self-reported IPAQ-SF. |
| Engagement in Intervention Components | Up to Week 4 | Composite measure of the proportion of participants completing self-affirmation task; self-reported proportion of text-messages read; text-message satisfaction. |
| Fitbit Average Daily Wear Time during 1-Week Post-Intervention | Week 4 | Average number of minutes worn per day. |
| Attrition | Up to Week 3 | Proportion of Participants who opt-out of text-messages. |
Countries
United States
Contacts
CONTACTRobin Ortiz, MD, MS
CONTACTElaine De Leon
PRINCIPAL_INVESTIGATORRobin Ortiz, MD, MS
NYU Langone Health
PRINCIPAL_INVESTIGATORElaine De Leon, MD
NYU Langone Health
Outcome results
None listed