There is an urgent need to engineer targeted physical activity interventions that are effective and scalable for obese adolescents and young adults (AYA) with type 2 diabetes (T2D), who often have very low levels of physical activity. The BEAM Trial is a mobile health (mHealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in AYA with T2D and prediabetes.
Some secondary outcome measures from the protocol were inadvertently left out when creating the registration and have been added with the results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
75
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Change in Moderate to Vigorous Physical Activity (MVPA)
Effects of time spent in MVPA was measured by assessing the change in weekly mean minutes in MVPA per day from baseline
Time frame: 12 weeks
Change in Daily Step Count
Daily step count will be measured by assessing the change in daily mean steps from baseline
Time frame: 12 weeks
Change in BMI Z-score
Z-score calculated using "zanthro" package in Stata, according to U.S. CDC growth charts. The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched adolescents and young adults). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. A Z-score of 0 represents the population mean. BMI Z-scores greater than 1.645 are consistent with pediatric obesity.
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Change in Plasma Glucose
mg/dL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Change in Insulin
uIU/mL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Change in Hemoglobin A1c
Percent (%)
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Change in Triglycerides
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One text per day, ramped goal, gain incentive, weekly goal time period.
Two texts per day, ramped goal, loss incentive, daily goal time period.
Two texts per day, ramped goal, loss incentive, weekly goal time period.
Two texts per day, ramped goal, gain incentive, daily goal time period.
Two texts per day, ramped goal, gain incentive, weekly goal time period.
One text per day, fixed goal, loss incentive, daily weekly goal time period.
One text per day, fixed goal, loss incentive, weekly goal time period.
One text per day, fixed goal, gain incentive, daily goal time period.
One text per day, fixed goal, gain incentive, weekly goal time period.
Two texts per day, fixed goal, loss incentive, daily goal time period.
Two texts per day, fixed goal, loss incentive, weekly goal time period.
Two texts per day, fixed goal, gain incentive, daily goal time period.
Two texts per day, fixed goal, gain incentive, weekly goal time period.
mg/dL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Change in Low-density Lipoprotein (LDL)
mg/dL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Change in High-density Lipoprotein (HDL)
mg/dL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Change in ALT
U/L
Time frame: From baseline to follow-up in-person study visits, separated by 3 months