Physical Activity and Glycemic Control in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- number of consecutive weeks step goal met
研究概览
简要总结
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.
详细描述
Specific aims are:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 13-24 years old and live with a parent at least 4 days per week on average;
- •diagnosis of type 1 diabetes >12 months via ADA guidelines;
- •mean A1c>7.5% and <13% in the year before study entry, and most recent A1c >7.5% but <13%;
- •check blood sugar at least 2 times per day on average;
- •access to a computer or cell phone with Internet for uploading or synching activity monitoring data and text messaging or email capabilities to communicate with study staff
- •currently walk at least 1,000 steps per day, but less than 6,000 steps per day on average as assessed on >11 days between baseline session 1 and baseline session 2
- •English speaking, pass an informed consent quiz, and adequate knowledge of managing T1D
排除标准
- •have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) or major visual impairment that would inhibit participation
- •have a significant other medical condition that impacts diabetes management (e.g., eating disorder, rheumatoid arthritis, or other condition that requires steroid treatment) or a physical illness, injury or condition that may interfere with physical activity recommendations (e.g., joint, hip or back problems, uncontrolled hypertension, or BMI > 40 kg/m2)
- •plan to switch insulin delivery mode (injection to pump or vice versa) in the next 6 months, or have recently switched
- •participating in another clinical trial
- •fail or is unable to upload or synch the activity meter at least 4 times during the baseline period
结局指标
主要结局
number of consecutive weeks step goal met
时间窗: 12 weeks
The number of weeks in a row in which the recommended number of steps was achieved on at least 5 of the 7 days.
proportion of days participants walked the recommended number of steps
时间窗: 12 weeks
The proportion of days participants walked the recommended number of steps which the recommended number of steps was achieved on at least 5 of the 7 days.
proportion of days in the month participants walked 10,000 or more steps
时间窗: 24 weeks
Long-term outcome will be proportion of days in the month before the 24-week follow up on which participants walked 10,000 or more steps.
次要结局
- Habitual Total Weekend Activity Score(24 weeks)
- proportion of days in the month participants walked 10,000 or more steps(12 weeks)
- Six Minute Walk Test(12 weeks)
- Physical Activity Questionnaire(24 weeks)
- proportion of days participants walked the recommended number of steps(24 weeks)
- Systolic Blood Pressure(24 weeks)
- Sit to Stand Test(12 weeks)
- Body Mass Index(24 weeks)
- Waist Circumference(24 weeks)
- Diastolic Blood Pressure(24 weeks)
- Harvard Step Test(24 weeks)
- Habitual Total Weekday Activity Score(24 weeks)