Physical Activity and Glycemic Control in Adolescents
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the initial efficacy of a reinforcement
      intervention to enhance physical activity levels in sedentary adolescents and young adults
      with type 1 diabetes (T1D). The intervention will reinforce patients for meeting physical
      activity goals, with escalating reinforcers provided when patients achieve continuous weeks
      of meeting goals. A 12-week trial will be conducted in which 60 patients will be randomized
      to: (1) standard care or (2) standard care plus reinforcement.
    

Detailed description: 
      Specific aims are:

        1. To determine if the reinforcement intervention increases walking. The proportion of days
           on which participants meet walking goals will be assessed via Fitbit, a commercially
           available activity monitor, as well as continuous weeks on which goals are met. The
           hypothesis is that patients assigned to the reinforcement intervention will meet walking
           goals on a higher proportion of days and have longer durations of meeting walking goals
           than patients assigned to standard care.

        2. To assess if the intervention reduces A1c. Patients randomized to the reinforcement
           intervention are expected to have greater decreases in A1c than patients in usual care.

      In addition to the primary aims, secondary outcomes will also be evaluated. The intervention
      is expected to enhance subjective and objective indices of fitness, increase quality of life,
      improve indices of diabetes management and decrease depression symptoms. Predictors of
      response to treatment will also be evaluated.

      Results from this pilot study will be instrumental for guiding a subsequent, larger and
      longer term randomized study for evaluating reinforcement interventions for improving
      outcomes of youth and young adults with T1D.
    

Intervention name(s): Reinforcement for meeting targeted physical activity goals; Standard of Care
Intervention type(s): Behavioral; Other
Intervention description(s): Participants in this condition will receive reinforcement for meeting targeted physical activity goals. These subjects will receive the same treatment as standard treatment group, including incentives for uploading/synching and discussions of ADA recommendations of managing diabetes in the context of physical activity. The only difference between conditions is that participants in this condition will earn tangible reinforcement for walking the target number of steps per day (6,000 per day in week 1, 8,000 per day in week 2 and 10,000 per day in weeks 3-12). At each upload, participants will earn incentives for each day on which they met the step goals. In addition, for each 7-day period in which they meet goals on at least 5 days, they will earn bonuses.; Participants in the standard of care group will be told to wear Fitbit daily for 12 weeks. They will be instructed to upload or synch it >2x/week, on set days, e.g., Mon and Thurs, for the next 6 weeks and then weekly in the last 6 weeks. They will receive incentives for each upload, plus a bonus for each week in which data are registered for all 7 days in the week as scheduled. They will be encouraged to review Fitbit steps daily and on each upload/synch day. After each upload, research staff will congratulate patients via email or text for days on which they met goals, and encourage meeting goals in the upcoming week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment