Type 1 Diabetes Clinical Trial
Official title:
Physical Activity and Glycemic Control in Adolescents
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.
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.
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