The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older

All participants will be provided a Fitbit Aria weight scale, a Fitbit Inspire 3 activity tracker, and a study tablet (Samsung Galaxy). At baseline (0) and 52 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves at the same time on at least 3 days during the week. Participants will be instructed to weigh themselves on their study-provided Aria scale right after waking up and emptying their bladder (and bowel, if possible). They should wear only a t-shirt and undergarments, and bare feet. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.

All participants will be provided a Fitbit Aria weight scale, a Fitbit Inspire 3 activity tracker, and a study tablet (Samsung Galaxy). At baseline (0) and 12 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves at the same time on at least 3 days during the week. Participants will be instructed to weigh themselves on their study-provided Aria scale right after waking up and emptying their bladder (and bowel, if possible). They should wear only a t-shirt and undergarments, and bare feet. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.

All participants will be provided a Fitbit Aria weight scale, a Fitbit Inspire 3 activity tracker, and a study tablet (Samsung Galaxy). At baseline (0), 6, 12, 24, and 52 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves at the same time on at least 3 days during the week. Participants will be instructed to weigh themselves on their study-provided Aria scale right after waking up and emptying their bladder (and bowel, if possible). They should wear only a t-shirt and undergarments, and bare feet. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.

All participants will receive a study-provided Fitbit Inspire 3 activity tracker with heart rate and sleep monitor, assistance with account and device setup. At 0, 6, 12, 24 and 52 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to wear their activity tracker for at least 10 hours on 3 or more days during the week. We will obtain participants' self-monitored number of steps using a developed program for automated daily synchronization via the Fitbit open API.

All participants will self-administer the International Physical Activity Questionnaire (IPAQ), a 7-item questionnaire that captures a participant's physical activity over the last 7 days.

Dietary intake will be measured using 17-item fruit, vegetable, fat, and fiber screener by self-report. Correlations between screener estimates and estimated true intake were 0.5-0.8.

Participants will complete validated self-administered scale of self-efficacy for weight control using the Weight Efficacy Lifestyle Questionnaire. Sum of scores of 8 items, with a range between 0 and 80. Higher scores indicate higher self-efficacy to control eating behaviors.

Participants will complete validated self-administered scale of self-efficacy for dietary change using the Eating Habits Confidence Survey. The total score is mean item scores, with a range between 1 and 5. Higher scores indicate higher diet self-efficacy (i.e., higher ability to avoid eating certain unhealthy foods).

Participants will complete validated self-administered scale of self-efficacy for physical activity using the Exercise Confidence Survey. The total score is mean item scores, with a range between 1 and 5. Higher scores indicate higher exercise self-efficacy (i.e., greater confidence in performing certain behaviors consistently for at least 6 months).

Participants will complete the Health Care Climate Questionnaire (HCCQ), which assessed their perceptions of the autonomy supportiveness of their care team. HCCQ contains 15 items, rated on a 5-point scale ranging from "not true at all" to "very true." After reversing the score of a negative item, an average score is calculated with higher score indicating a higher level of perceived autonomy support.

Participants' problem solving abilities will be assessed using the reliable and valid SPSI-R:S that contains 25 items in the following 5 subscales: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving (RPS), impulsive/careless style (ICS), and avoidance style (AS). Each item is rated on a 5-point scale ranging from "not at all true of me" (0) to "extremely true of me" (4). SPSI-R:S is a short version of the long SPSI-R:L form which has Cronbach's alpha coefficient of 0.95 for the total score and of 0.67-0.92 for subscales.

The 13-item PAM measures patient's self-reported knowledge, skill, and confidence for self-managing his or her health condition. It demonstrated acceptable internal consistency (Conbrach's alpha = 0.81). The 13-item PAM score accounts for 92% of the variation in the activity measured by the original 22-item PAM. The score is also significantly correlated with general preventive behaviors and disease-specific self-management behaviors.

Perceived Stress Scale (PSS) measures the perception of stress (i.e., the degree to which situations in one's life are appraised as stressful). PSS contains 14 items, rated on a 5-point scale ranging from "never" to "very often." After reversing the scores on 7 positive items, a sum of score is calculated with higher score indicating higher perceived stress. Cronbach's alpha ranged from 0.84 to 0.86.

Sleep disturbance is assessed on the 8-item PROMIS sleep disturbance scale short form which measures symptoms of insomnia. Each item is scaled from 1 (not at all) to 5 (very much). Sleep disturbance score=(Raw sum ×number of items on the short form) / number of items answered. The higher the score the greater sleep disturbance.

Sleep impairment is assessed on the 8-item PROMIS sleep-related impairment scale short form which measures symptoms of daytime sleepiness. Each item is scaled from 1 (not at all) to 5 (very much). Sleep impairment score=(Raw sum ×number of items on the short form) / number of items answered. The higher the score the greater sleep impairment.

Cognitive functioning will be assessed on the PROMIS version 1.0 short-form subscales of Cognitive Abilities and Cognitive Concerns. Each subscale contains 8 items. The Cognitive Abilities items target positive self-assessments of cognitive functioning such as "My memory has been as good as usual" and "I have been able to concentrate." The Cognitive Concerns items are worded negatively and express concerns in the same areas, for examples, "My thinking has been slow" and "I have had trouble shifting back and forth between different activities that require thinking." Items on both subscales use a 5-point rating from "not at all" to "very much." Items are summed to create a total score for each subscale.

The non-laboratory Framingham risk prediction model estimates individuals' 10-year risk of developing any major atherosclerotic cardiovascular disease (CVD) event. The component risk factors are age, BMI, systolic blood pressure, smoking status, presence of diabetes, and medication for high blood pressure. Participants will be asked to confirm their age and report their smoking history at baseline and current smoking status at baseline and 52 weeks. The BMI will be calculated based on participants' self-measured weight data as described above and height measurements abstracted from their EHR. Blood pressure, diagnosis of diabetes, and prescriptions for high blood pressures will also be abstracted from the EHR.

The Cumulative Illness Rating Scale (CIRS) is a composite index of the number and severity of medical problems by organ system. It has been validated in diverse populations and settings, including primary care patients, with published guidelines and electronic tools for application and scoring using electronic health record (EHR) data.