Individual and Family-based Approaches to Increase Physical Activity in Adolescents With IDD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Change in Adolescent Physical Activity From Baseline to 6 Months
研究概览
简要总结
The objective of this study is to compare the effect of two strategies to increase MVPA in adolescents with intellectual and developmental disabilities (IDD): a single level intervention delivered to the adolescent only, and a multi-level intervention delivered to both the adolescent and a parent .
详细描述
We will study adolescents with mild to moderate IDD. Each participant will have 1 designated parent who supports the participant during the physical activity (PA) intervention and in the adolescent and parent arm does the physical activity with the participant. Approximately 29 participants/yr. over 4 yrs. will be randomized in a 1:1 allocation to a remote group-based program of MVPA delivered to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A+P). Both interventions will be 12 mos. (6 mos. active intervention, 6 mos. maintenance intervention) with a 6 mos. no-contact follow-up targeted to increase MVPA to the recommended 60 min/d. Both intervention will include real-time MVPA sessions delivered to groups of 5-7 adolescents in their homes using video conferencing software (ZoomTM) with homework assignments designed to increase MVPA on the non-group session days. Parents of adolescents in the A+P group will be asked to participate in the group video MVPA sessions and homework activity, and to attend sessions (0-6 mos. 2 session/mo.; 7-12 mos. 1 session/mo.) with their adolescent and the health coach designed to educate/support parents regarding the role of MVPA in health and function and strategies for increasing MVPA and decreasing sedentary time in both their adolescent and themselves. All participants will monitor their daily PA using a Fitbit wireless activity tracker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate IDD (IQ of 74-40).
- •Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.
- •Living at home with a parent or guardian who is willing to participate in the intervention, with no plans to change this living situation and/or to leave the study area in the next 18 mos.
- •Wireless internet access in the home.
排除标准
- •Unable to participate in moderate to vigorous physical activity (MVPA).
- •Pregnancy during the previous 6 mos., currently lactating, or planned pregnancy in the following 18 mos.
- •Unwilling to be randomized.
结局指标
主要结局
Change in Adolescent Physical Activity From Baseline to 6 Months
时间窗: Change from baseline to 6 months
Moderate to vigorous physical activity was assessed using an ActiGraph accelerometer worn during waking hours for 7 consecutive days, with the exception of bathing, and swimming. Data were considered valid if they wore the accelerometer for at least 8 hours on 3 days, including 1 weekend day.
次要结局
- Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months(Change from baseline to 18 months)
- Change in Quality of Life(Change from baseline to 18 months)
- Change in Parent Sedentary Time(Change from baseline to 18 months)
- Change in Muscular Strength(Change from baseline to 18 months)
- Change in Cardiovascular Fitness(Change from baseline to 18 months)
- Change in Motor Ability(Change from baseline to 18 months)
- Change in Parent Physical Activity(Change from baseline to 18 months)
- Change in Sedentary Time(Change from baseline to 18 months)