Change in Patient reported outcomes measurement information systems (PROMIS)- Global health
PROMIS (Patient Reported Outcomes Measurement Information System) gauges physical, mental, and social aspects of health (5-point scale). A mean standardized score for the population is 50; 10 points indicate one standard deviation. Higher scores indicate better health. Range (0-100)
Change in Patient reported outcomes measurement information systems (PROMIS)- Physical function
Self-reported physical function (5-point scale) measure that is a responsive measure evaluating mobility and activities of daily living; A mean standardized score for the population is 50; 10 points indicate one standard deviation. Higher scores indicate better health. Range (0-100)
Change in 30-second sit-to-stand from baseline
This is a construct of physical function that predicts falls and disability and is sensitive to change. The 30-second sit-to-stand test is administered using a folding chair without arms and involves recording the number of stands from a seated position a person can complete in 30 seconds. Change in 30-s sit-to-stand in repetitions over time will be reported from baseline to 78-weeks. An improvement in repetitions will represent an improvement of physical function. The continuous value correlates with quadriceps Minimal Clinically Important Difference (2.0 repetitions)
Change in grip strength from baseline
An objective measure that relates to upper and lower extremity strength, and predicts mobility disability. Using a Jamar dynamometer, change in participant's maximal grip strength measurement in kilograms from baseline. Absolute change in grip strength in kilograms over time will be reported from baseline to 78-weeks. An increase in kilograms represented on the device will represent an improvement of physical function. No cutoffs will be used for this - the research team will be use the continuous value.
Change in gait speed from baseline
Gait speed (measured in meters/second or m/s) measures how long it takes a person to travel a given distance. It is A simple, clinical measure of objective physical function that reflects health and functional status and predicts falls, disability, and mortality. Gait Speed is measured using the time in seconds it takes a participant to complete a 4 meter course while walking at a usual pace. Gait speed is measured as distance (meters) ÷ time (seconds). An absolute change in gait speed will be the difference from follow-up measures and baseline. An improvement in gait speed represents an improvement in physical function. Units are meters/second. Normal >1.2m/s.
Change in 6-minute walk from baseline
A measure of aerobic endurance (normal distance 400-700m) that is a surrogate for submaximal aerobic/cardiovascular fitness. Clinically significant change ranges between 14-30.5 m.
Change in waist circumference from baseline
Absolute change in waist circumference in centimeters (cm) over time from baseline. Waist circumference will be measured objectively using a tape measure. A negative number will indicate a loss in waist circumference
Change in hip circumference from baseline
Absolute change in hip circumference in centimeters (cm) over time from baseline. Hip circumference will be measured objectively using a tape measure. A negative number will indicate a loss of hip circumference
Proportion with greater than or equal to 5% weight loss
The proportion achieving a clinically significant 5% weight loss
Change in % body fat from baseline
Dual x-ray absorptiometry (General Electric Lunar iDXA) software will assess total body fat % (percent). A reduction in the percentage of total body fat is suggestive of improvements in health related outcomes.
Change in volume of visceral fat from baseline
Dual x-ray absorptiometry (General Electric Lunar iDXA) software will assess visceral fat mass % (percent). A reduction in visceral fat volume is suggestive of improvements in health related outcomes.
Change in appendicular lean mass from baseline
Dual x-ray absorptiometry (General Electric Lunar iDXA) software will assess percent (%) lean mass (total, segmental). A reduction in lean mass percentage is suggestive of worsening of health related outcomes.
Late-life function and disability instrument
Self-reported 32-item physical function measure consisting of function and life-task items that correlate with gait speed and lower-limb function. A 2-point difference is clinically significant. Range, (scaled score, 0-100). Higher scores indicate better performance and less limitation than lower scores.
Change in Pittsburgh Fatigability questionnaire
The 15-item Pittsburgh Fatigability Scale measures perceived fatigue of sedentary, social, lifestyle and physical activities (light-high intensity, 0-50 scale). Cutoff of ≥15 and ≥13 indicate higher physical and mental fatigue that may lead to reduced performance or restricted activity. Higher scores indicate greater perceived physical or mental fatigability. A reduction in the absolute change in score suggests improvements in fatigue.
Change in Self-efficacy- exercise
The Self-Efficacy for Exercise Scale (range 0-90) is based on the Social Cognitive Theory (higher scores mean higher self-efficacy for initiating/maintaining exercise). A positive change in self-efficacy reflects better outcomes, and a negative change reflects worse outcomes.
Change in Self-efficacy- nutrition
The 8-item Weight-Efficacy Lifestyle Short Form measures confidence in adopting and maintaining weight loss behaviors. A 15-point change was related to a 25% weight loss in bariatric surgery participants. Range (0-80). A positive change in self-efficacy reflects better outcomes, and a negative change reflects worse outcomes.
Change in Self-efficacy- technology
A 10-item Likert scale (1-10) will measure daily Technology Self-Efficacy (higher score means higher self-efficacy). Range (0-100)
Change in Goal setting- exercise
Only conducted in the Behavioral arms. This is a Likert Scale question, where answers can range from 1-10, with higher scores indicating better goal setting abilities
Change in Goal setting- nutrition
Only conducted in the Behavioral arms. This is a Likert Scale questionnaire, where answers can range from 1-10, with higher scores indicating better goal setting abilities.
Change in Goal setting- technology
Only conducted in the Behavioral arms. This is a Likert Scale questionnaire, where answers can range from 1-10, with higher scores indicating better goal setting abilities.
Change in social support for diet
A validated scale that assesses friends/family support for engaging in dietary changes. Higher scores indicate higher social support. Each are scored for family and friends separately (range 0-100).
Change in social support for exercise
A validated scale that assesses friends/family support for engaging in dietary exercises. Higher scores indicate higher social support. Each are scored for family and friends separately (range 0-60).
Treatment self-regulation: diet
A validated 15-item, 7-point scale (range 0-100) reflecting autonomous motivation and controlled motivation. Higher scores indicate better outcomes.
Treatment self-regulation: exercise
A validated 15-item, 7-point scale (range 0-100) reflecting autonomous motivation and controlled motivation. Higher scores indicate better outcomes.
Change in caloric intake
Using the Automated Self-Administered 24-hour Dietary Assessment (ASA-24), the investigators will measure caloric intake per day. Change measured in the difference between calories per day at baseline, throughout study, and follow-up assessment. This is an automated food recall that assess caloric intake. A change in caloric intake will be reported in kcal per day. Reduction in caloric input suggests reduced calorie intake.
Physical activity: community healthy activities model program for seniors
This questionnaire, known as CHAMPS (community healthy activities model program for seniors), will assess activity levels and types (weekly caloric expenditure; frequency of activities) and their changes. The investigators will use a standardized algorithm to assess low, moderate, vigorous activity and caloric output
Patient activation measure
Patient Activation Measure assesses knowledge, skills & confidence for managing health revealing insights into motivators, behaviors, attitudes & outcomes (4 points each; score 0-100, low to high) 0, 8, 16, 26, 52, 78 weeks
Fitbit use- Wear/non-wear time
Measurement using Fitbit data of the time spent during the day wearing the device.
Fitbit use- activity/steps
Evaluation using Fitbit data of the average number of steps (and total number to that point) a participant has engaged in
Attendance
Feasibility of study procedures measured as the mean attendance rate of all participants. Participant attendance rate = (total # of visits attended / total # of visits scheduled) x 100. There are no cut-off scores for interpretation. Higher scores indicate higher feasibility
Acceptability of Study Intervention
Measured through an end of study satisfaction survey, acceptability is measured on a 10 point Likert scale conducted on all participants at 78-weeks. This is rated on a 1 (strongly disagree) to 10 (strongly agree) survey.
Percent of participants rating the intervention as acceptable
Conducted on all participants using a 1-5 Likert scale to assess appropriateness of the study intervention measures using the following: completely disagree, disagree, neither agree or disagree, agree, completely agree. Acceptability is reported as Agree or Completely Agree responses. Percent is calculated as total number of participants rating as agree or complete agree divided by the number of total participants.
Telehealth satisfaction
A end-of-study questionnaire that assesses patient satisfaction regarding the use of Telehealth (Likert scale, 1-10). Range 0-100. Higher scores indicate better outcomes.
Telehealth usability survey
A single item Likert scale (1-10) will measure usefulness, ease of use, effectiveness, reliability & satisfaction of telemedicine. This will be measured at the conclusion of the study intervention. Range 0-100. Higher scores indicate better outcomes.
Change in systolic blood pressure
The difference between baseline and follow-up values-measured in mmHg (millimeters of mercury)- a value of 5mmHg (millimeters of mercury) is clinically significant
Change in diastolic blood pressure
The difference between baseline and follow-up values (measured in mmHg)- a value of 5mmHg (millimeters of mercury) is clinically significant
Change in low density lipoprotein blood levels
The difference between baseline and follow-up values measured in mg/dL (milligrams per deciliter) using a lipid panel. Levels >100mg/dL would be potentially clinically actionable.
0, 8, 52 weeks
Change in high density lipoprotein blood levels
The difference between baseline and follow-up values measured in mg/dL (milligrams per deciliter) using a lipid panel
Change in total cholesterol blood levels
The difference between baseline and follow-up values measured in mg/dL (milligrams per deciliter) using a lipid panel
Change in glucose blood levels
The difference between baseline and follow-up values, units in mg/dL (milligrams per deciliter). A glucose level >126mg/dL is considered diabetic.
Change in calf circumference from baseline
Change in calf circumference in centimeters (cm) over time from baseline to 12-weeks. Calf circumference will be measured objectively using a tape measure. A negative number will indicate a loss in calf circumference
Change in arm circumference from baseline
Change in arm circumference in centimeters (cm) over time from baseline to 12-weeks. Arm circumference will be measured objectively using a tape measure. A negative number will indicate a loss in arm circumference.