Reduce Sedentary Time in Acute Lymphoblastic Leukemia

Recruitment rate will serve as one of the primary markers of study feasibility to inform future trials. Number of participants recruited per week will be tracked to calculate the total participants enrolled at 6 months.

Retention rate will also be a defining measure of study feasibility. Number of participants who complete all questionnaires at baseline and 12 weeks will be divided by the total number of participants to determine the retention rate.

Fitness tracker (Fitbit) wear time for each participant will be measured by the number of hours per day with detectable heart rate measurement. Total hours of fitness tracker wear time will be divided by total number of intervention days to calculate average daily wear time.

Participant acceptability of the sedentary time intervention will be assessed via exit surveys and semi-structured qualitative interviews with study participants at the end of the 12-week study period. The exit survey will assess participants' opinions on the perceived effectiveness of the intervention overall, as well as each intervention component (Fitbit with reminders to move, coaching sessions, app-based per support group), via Likert-scale questions.

Sedentary time will be measured using an activity monitor applied to the right thigh (ActivPAL accelerometer) that tracks how much time someone spends in low-intensity activities done while sitting or lying down (sedentary behaviors) over a 7-day period. Total minutes of sedentary time acquired will be divided by the number of valid accelerometer wear days to calculate the average minutes of sedentary time per day, which will be compared from baseline to post-intervention.

For all participants, sedentary time will be measured using an activity monitor applied to the right thigh (ActivPAL accelerometer) that tracks how much time someone spends in low-intensity activities done while sitting or lying down (sedentary behaviors) over a 7-day period. An uninterrupted sedentary hour will be defined as an hour with <250 steps. Total hours of uninterrupted sedentary time acquired will be divided by valid accelerometer wear days to calculate the average hours of uninterrupted sedentary time per day, which will be compared from baseline to post-intervention.

A non-fasting blood sample (up to 2 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0) and post-intervention (Week 12) for measurement of hemoglobin A1c, which provides an average of blood glucose trends over the past 2-3 months.

A non-fasting blood sample (up to 2 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0), Week 8, and post-intervention (Week 12) for measurement of fructosamine, which provides an average of blood glucose trends over the past 2-4 weeks. Fructosamine level at 8 weeks will be compared to the baseline level.

A non-fasting blood sample (up to 2 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0), Week 8, and post-intervention (Week 12) for measurement of fructosamine, which provides an average of blood glucose trends over the past 2-4 weeks. Fructosamine level at 12 weeks will be compared to the baseline level.

A non-fasting blood sample (up to 1 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0), Week 8, and post-intervention (Week 12) for measurement of CRP, which is a general marker of bodily inflammation. CRP level at 8 weeks will be compared to the baseline level.

A non-fasting blood sample (up to 1 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0), Week 8, and post-intervention (Week 12) for measurement of CRP, which is a general marker of bodily inflammation. CRP level at 12 weeks will be compared to the baseline level.

Self-reported HRQOL will be measured with the 23-item Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales (physical functioning, emotional functioning, social functioning, and school functioning) and 27-item PedsQL 3.0 Cancer Module (pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication). Items are reversed scored and linearly transformed on a scale from 0 to 100, with higher scores indicating better HRQOL and fewer problems or symptoms. Participant's scores at 12 weeks will be compared to the baseline score.

Self-reported fatigue will be measured with the 18-item Pediatric Quality of Life inventory (PedsQL) 3.0 Multidimensional Fatigue Scale (general fatigue, sleep/rest fatigue, cognitive fatigue). Items are reversed scored and linearly transformed on a scale from 0 to 100, with higher scores indicating better HRQOL and fewer problems or symptoms. Participant's scores at 12 weeks will be compared to the baseline score.

As an optional procedure, a fasting blood sample (up to 3 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0) and post-intervention (Week 12) for measurement of a lipid panel, which includes total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol. The lipid panel evaluates for abnormalities is different types of lipids/cholesterol, which can be risk factors for heart disease, including high total cholesterol. Total cholesterol at 12 weeks will be compared to the baseline level.

As an optional procedure, a fasting blood sample (up to 3 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0) and post-intervention (Week 12) for measurement of a lipid panel, which includes total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol. The lipid panel evaluates for abnormalities is different types of lipids/cholesterol, which can be risk factors for heart disease, including high triglycerides. The triglyceride level at 12 weeks will be compared to the baseline level.

As an optional procedure, a fasting blood sample (up to 3 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0) and post-intervention (Week 12) for measurement of a lipid panel, which includes total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol. The lipid panel evaluates for abnormalities is different types of lipids/cholesterol, which can be risk factors for heart disease, including high LDL cholesterol. The LDL cholesterol level at 12 weeks will be compared to the baseline level.

As an optional procedure, a fasting blood sample (up to 3 mLs) will be collected via venipuncture or central line access along with clinically required labs at baseline (Week 0) and post-intervention (Week 12) for measurement of a lipid panel, which includes total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol. The lipid panel evaluates for abnormalities is different types of lipids/cholesterol, which can be risk factors for heart disease, including low HDL cholesterol. The HDL cholesterol level at 12 weeks will be compared to the baseline level.