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BACKGROUND Few studies examined the association between depressive symptom trajectories and objectively measured physical activity. OBJECTIVE We aimed to investigate if antecedent depressive symptoms predict subsequent daily step counts among participants in the electronic Framingham Heart Study (eFHS). METHODS We performed group-based multi-trajectory modeling to construct depressive symptom trajectory groups using both depressive symptoms (CES-D >16) and antidepressant use in eFHS participants who attended three FHS research exams over fourteen years. At the third exam, eFHS participants were provided with a study smartwatch for measuring daily step counts. We performed linear mixed models to examine the association between depressive symptom trajectories and daily step counts over one-year follow-up adjusting for age, sex, wear-hour, body mass index, and smoking status. RESULTS We identified two depressive symptom trajectory groups from 724 eFHS participants (mean age 53 years, 60% women). The low symptom group (n=566; mean follow-up 286±111 days) consisted of ≤5% of participants with depressive symptoms and ≤1% reporting antidepressant medication use, and the high symptom group (n = 158; 269±113 days) consisted of ≥28% of participants with depressive symptoms and ≥47% reporting antidepressant medication use across the three exams. Compared to those in the low symptom group, participants in the high symptom group walked fewer daily steps during one-year follow-up (690 fewer; 95% CI: 254-1125). CONCLUSIONS Antecedent depressive symptoms/anti-depressive medication use was associated with lower subsequent daily step counts in eFHS. Our findings suggest that adding interventions to improve mood via mHealth technologies may help promote people’s daily physical activity.

Background Smartphone apps and mobile health devices offer innovative ways to collect longitudinal cardiovascular data. Randomized evidence regarding effective strategies to maintain longitudinal engagement is limited. Objective This study aimed to evaluate smartphone messaging interventions on remote transmission of blood pressure (BP) and heart rate (HR) data. Methods We conducted a 2 × 2 × 2 factorial blinded randomized trial with randomization implemented centrally to ensure allocation concealment. We invited participants from the Electronic Framingham Heart Study (eFHS), an e-cohort embedded in the FHS, and asked participants to measure their BP (Withings digital cuff) weekly and wear their smartwatch daily. We assessed 3 weekly notification strategies to promote adherence: personalized versus standard; weekend versus weekday; and morning versus evening. Personalized notifications included the participant’s name and were tailored to whether or not data from the prior week were transmitted to the research team. Intervention notification messages were delivered weekly automatically via the eFHS app. We assessed if participants transmitted at least one BP or HR measurement within 7 days of each notification after randomization. Outcomes were adherence to BP and HR transmission at 3 months (primary) and 6 months (secondary). Results Of the 791 FHS participants, 655 (82.8%) were eligible and randomized (mean age 53, SD 9 years; 392/655, 59.8% women; 596/655, 91% White). For the personalized versus standard notifications, 38.9% (126/324) versus 28.8% (94/327) participants sent BP data at 3 months (difference=10.1%, 95% CI 2.9%-17.4%; P=.006), but no significant differences were observed for HR data transmission (212/324, 65.4% vs 209/327, 63.9%; P=.69). Personalized notifications were associated with increased BP and HR data transmission versus standard at 6 months (BP: 107/291, 36.8% vs 66/295, 22.4%; difference=14.4%, 95% CI 7.1- 21.7%; P Conclusions Personalized notifications increased longitudinal adherence to BP and HR transmission from mobile and digital devices among eFHS participants. Our results suggest that personalized messaging is a powerful tool to promote adherence to mobile health systems in cardiovascular research. Trial Registration ClinicalTrials.gov NCT03516019; https://clinicaltrials.gov/ct2/show/NCT03516019

BACKGROUND The prevalence of obesity is rising. Most previous studies that examined the relations between BMI and physical activity (PA) measured BMI at a single timepoint. The association between BMI trajectories and habitual PA remains unclear. OBJECTIVE This study assesses the relations between BMI trajectories and habitual step-based PA among participants enrolled in the electronic cohort of the Framingham Heart Study (eFHS). METHODS We used a semiparametric group-based modeling to identify BMI trajectories from eFHS participants who attended research examinations at the Framingham Research Center over 14 years. Daily steps were recorded from the smartwatch provided at examination 3. We excluded participants with RESULTS We identified 3 trajectory groups for the 837 eFHS participants (mean age 53 years; 57.8% [484/837] female). Group 1 included 292 participants whose BMI was stable (slope 0.005; P=.75), group 2 included 468 participants whose BMI increased slightly (slope 0.123; PP CONCLUSIONS In this community-based eFHS, participants whose BMI trajectory increased greatly over time took significantly fewer steps, compared with participants with stable BMI trajectories. Our findings suggest that greater weight gain may correlate with lower levels of step-based physical activity.

BACKGROUND Daily routines (eg, physical activity and sleep patterns) are important for diabetes self-management. Traditional research methods are not optimal for documenting long-term daily routine patterns in participants with glycemic conditions. Mobile health offers an effective approach for collecting users’ long-term daily activities and analyzing their daily routine patterns in relation to diabetes status. OBJECTIVE This study aims to understand how routines function in diabetes self-management. We evaluate the associations of daily routine variables derived from a smartwatch with diabetes status in the electronic Framingham Heart Study (eFHS). METHODS The eFHS enrolled the Framingham Heart Study participants at health examination 3 between 2016 and 2019. At baseline, diabetes was defined as fasting blood glucose level ≥126 mg/dL or as a self-report of taking a glucose-lowering medication; prediabetes was defined as fasting blood glucose level of 100-125 mg/dL. Using smartwatch data, we calculated the average daily step counts and estimated the wake-up times and bedtimes for the eFHS participants on a given day. We compared the average daily step counts and the intraindividual variability of the wake-up times and bedtimes of the participants with diabetes and prediabetes with those of the referents who were neither diabetic nor prediabetic, adjusting for age, sex, and race or ethnicity. RESULTS We included 796 participants (494/796, 62.1% women; mean age 52.8, SD 8.7 years) who wore a smartwatch for at least 10 hours/day and remained in the study for at least 30 days after enrollment. On average, participants with diabetes (41/796, 5.2%) took 1611 fewer daily steps (95% CI 863-2360; PPP=.005) in the variation of their estimated bedtimes compared with the referents (546/796, 68.6%) without diabetes or prediabetes. Participants with prediabetes (209/796, 26.2%) also walked fewer daily steps (P=.04) and had a larger variation in their estimated wake-up times (P=.04) compared with the referents. CONCLUSIONS On average, participants with diabetes at baseline walked significantly fewer daily steps and had larger variations in their wake-up times and bedtimes than the referent group. These findings suggest that modifying the routines of participants with poor glycemic health may be an important approach to the self-management of diabetes. Future studies should be designed to improve the remote monitoring and self-management of diabetes. CLINICALTRIAL

BACKGROUND eCohort studies offer an efficient approach for data collection. However, eCohort studies are challenged by volunteer bias and low adherence. We designed an eCohort embedded in the Framingham Heart Study (eFHS) to address these challenges and to compare the digital data to traditional data collection. OBJECTIVE The aim of this study was to evaluate adherence of the eFHS app-based surveys deployed at baseline (time of enrollment in the eCohort) and every 3 months up to 1 year, and to compare baseline digital surveys with surveys collected at the research center. METHODS We defined adherence rates as the proportion of participants who completed at least one survey at a given 3-month period and computed adherence rates for each 3-month period. To evaluate agreement, we compared several baseline measures obtained in the eFHS app survey to those obtained at the in-person research center exam using the concordance correlation coefficient (CCC). RESULTS Among the 1948 eFHS participants (mean age 53, SD 9 years; 57% women), we found high adherence to baseline surveys (89%) and a decrease in adherence over time (58% at 3 months, 52% at 6 months, 41% at 9 months, and 40% at 12 months). eFHS participants who returned surveys were more likely to be women (adjusted odds ratio [aOR] 1.58, 95% CI 1.18-2.11) and less likely to be smokers (aOR 0.53, 95% CI 0.32-0.90). Compared to in-person exam data, we observed moderate agreement for baseline app-based surveys of the Physical Activity Index (mean difference 2.27, CCC=0.56), and high agreement for average drinks per week (mean difference 0.54, CCC=0.82) and depressive symptoms scores (mean difference 0.03, CCC=0.77). CONCLUSIONS We observed that eFHS participants had a high survey return at baseline and each 3-month survey period over the 12 months of follow up. We observed moderate to high agreement between digital and research center measures for several types of surveys, including physical activity, depressive symptoms, and alcohol use. Thus, this digital data collection mechanism is a promising tool to collect data related to cardiovascular disease and its risk factors.

BACKGROUND New electronic cohort (e-Cohort) study designs provide resource-effective methods for collecting participant data. It is unclear if implementing an e-Cohort study without direct, in-person participant contact can achieve successful participation rates. OBJECTIVE The objective of this study was to compare 2 distinct enrollment methods for setting up mobile health (mHealth) devices and to assess the ongoing adherence to device use in an e-Cohort pilot study. METHODS We coenrolled participants from the Framingham Heart Study (FHS) into the FHS–Health eHeart (HeH) pilot study, a digital cohort with infrastructure for collecting mHealth data. FHS participants who had an email address and smartphone were randomized to our FHS-HeH pilot study into 1 of 2 study arms: remote versus on-site support. We oversampled older adults (age ≥65 years), with a target of enrolling 20% of our sample as older adults. In the remote arm, participants received an email containing a link to enrollment website and, upon enrollment, were sent 4 smartphone-connectable sensor devices. Participants in the on-site arm were invited to visit an in-person FHS facility and were provided in-person support for enrollment and connecting the devices. Device data were tracked for at least 5 months. RESULTS Compared with the individuals who declined, individuals who consented to our pilot study (on-site, n=101; remote, n=93) were more likely to be women, highly educated, and younger. In the on-site arm, the connection and initial use of devices was ≥20% higher than the remote arm (mean percent difference was 25% [95% CI 17-35] for activity monitor, 22% [95% CI 12-32] for blood pressure cuff, 20% [95% CI 10-30] for scale, and 43% [95% CI 30-55] for electrocardiogram), with device connection rates in the on-site arm of 99%, 95%, 95%, and 84%. Once connected, continued device use over the 5-month study period was similar between the study arms. CONCLUSIONS Our pilot study demonstrated that the deployment of mobile devices among middle-aged and older adults in the context of an on-site clinic visit was associated with higher initial rates of device use as compared with offering only remote support. Once connected, the device use was similar in both groups.

BACKGROUND New models of scalable population-based data collection that integrate digital and mobile health (mHealth) data are necessary. OBJECTIVE The aim of this study was to describe a cardiovascular digital and mHealth electronic cohort (e-cohort) embedded in a traditional longitudinal cohort study, the Framingham Heart Study (FHS). METHODS We invited eligible and consenting FHS Generation 3 and Omni participants to download the electronic Framingham Heart Study (eFHS) app onto their mobile phones and co-deployed a digital blood pressure (BP) cuff. Thereafter, participants were also offered a smartwatch (Apple Watch). Participants are invited to complete surveys through the eFHS app, to perform weekly BP measurements, and to wear the smartwatch daily. RESULTS Up to July 2017, we enrolled 790 eFHS participants, representing 76% (790/1044) of potentially eligible FHS participants. eFHS participants were, on average, 53±8 years of age and 57% were women. A total of 85% (675/790) of eFHS participants completed all of the baseline survey and 59% (470/790) completed the 3-month survey. A total of 42% (241/573) and 76% (306/405) of eFHS participants adhered to weekly digital BP and heart rate (HR) uploads, respectively, over 12 weeks. CONCLUSIONS We have designed an e-cohort focused on identifying novel cardiovascular disease risk factors using a new smartphone app, a digital BP cuff, and a smartwatch. Despite minimal training and support, preliminary findings over a 3-month follow-up period show that uptake is high and adherence to periodic app-based surveys, weekly digital BP assessments, and smartwatch HR measures is acceptable.

Background New electronic cohort (e-Cohort) study designs provide resource-effective methods for collecting participant data. It is unclear if implementing an e-Cohort study without direct, in-person participant contact can achieve successful participation rates. Objective The objective of this study was to compare 2 distinct enrollment methods for setting up mobile health (mHealth) devices and to assess the ongoing adherence to device use in an e-Cohort pilot study. Methods We coenrolled participants from the Framingham Heart Study (FHS) into the FHS–Health eHeart (HeH) pilot study, a digital cohort with infrastructure for collecting mHealth data. FHS participants who had an email address and smartphone were randomized to our FHS-HeH pilot study into 1 of 2 study arms: remote versus on-site support. We oversampled older adults (age ≥65 years), with a target of enrolling 20% of our sample as older adults. In the remote arm, participants received an email containing a link to enrollment website and, upon enrollment, were sent 4 smartphone-connectable sensor devices. Participants in the on-site arm were invited to visit an in-person FHS facility and were provided in-person support for enrollment and connecting the devices. Device data were tracked for at least 5 months. Results Compared with the individuals who declined, individuals who consented to our pilot study (on-site, n=101; remote, n=93) were more likely to be women, highly educated, and younger. In the on-site arm, the connection and initial use of devices was ≥20% higher than the remote arm (mean percent difference was 25% [95% CI 17-35] for activity monitor, 22% [95% CI 12-32] for blood pressure cuff, 20% [95% CI 10-30] for scale, and 43% [95% CI 30-55] for electrocardiogram), with device connection rates in the on-site arm of 99%, 95%, 95%, and 84%. Once connected, continued device use over the 5-month study period was similar between the study arms. Conclusions Our pilot study demonstrated that the deployment of mobile devices among middle-aged and older adults in the context of an on-site clinic visit was associated with higher initial rates of device use as compared with offering only remote support. Once connected, the device use was similar in both groups.