Care2bWell: A Worksite Physical Activity & Wellness Program for Child Care Staff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 553
- 试验地点
- 2
- 主要终点
- Change in moderate to vigorous physical activity (MVPA)
研究概览
简要总结
This study will evaluate the efficacy of a 6-month child care-based intervention to improve workers' physical activity and other health-related behaviors compared to an attention control intervention (Healthy Lifestyles vs. Healthy Finances). The study sample will use a cluster randomized design and a sample of 104 child care centers and 416 child care workers (4 workers/center). The intervention arm will receive a 6-month child care-based intervention designed to improve workers' moderate to vigorous physical activity (MVPA) and other health-related behaviors (Healthy Lifestyles). The control arm (attention control) will receive a similarly structured program about financial health (Healthy Finances). The primary outcome is workers' MVPA; and secondary outcomes include workers' dietary intake, weight, smoking, sleep, and stress, as well as the centers' health supportive policies/structures for staff wellness and the overall physical activity environment for children. All primary and secondary outcomes will be assessed at baseline, post-intervention (6 months), and maintenance (18 months).
详细描述
The proposed study will evaluate the efficacy of a 6-month, child care-based intervention to increase workers' MVPA and other health-related behaviors (Healthy Lifestyles) compared to an attention control condition (Healthy Finances). This study will use a two-arm, cluster-randomized controlled trial (RCT) and a sample of 104 child care centers and 416 workers (4 workers/center). The primary outcome will be workers' MVPA; and secondary outcomes include workers' weight, dietary intake, smoking status, sleep habits, and emotional health as well as child care centers' programs, policies and environment around worksite wellness and teachers' interactions with children around physical activity. All primary and secondary outcomes will be assessed at baseline, post-intervention (6 months), and maintenance (18 months).
For this study, 104 child care centers will be recruited from a mix of urban/suburban and rural areas. Potential child care centers in these counties will be identified using an online database of licensed child care facilities maintained by the North Carolina (NC) Division of Child Development and Early Education. State and local community partners will be engaged to help inform centers in targeted counties about the research study. Direct recruitment of centers will employ a variety of strategies (e.g., mail, email, telephone, website, video, in-person contacts). Once a center expresses interest, the center director will be engaged to recruit their staff (child care workers) to participate as a team.
Outcome Measures:
A series of measurements will be collected on participating child care center directors and staff at three time points - baseline, follow-up (6 months), and maintenance (18 months). Primary outcome measures will assess moderate to vigorous physical activity (MVPA) of center staff. Secondary outcomes measures will assess staff members' behavioral health risk factors as well as centers' programs, policies and environment around worksite wellness and teachers' interactions with children around physical activity. These measures will be collected during a one-day, on-site visit to the child care center, and supplemented with physical health assessments completed at the kick-off event. Center visits will be conducted by research assistants who have undergone extensive training and certification on all measurement procedures and are blinded to study-arm assignment. Similar data collection protocols will be used at all three time points - baseline, follow-up and maintenance.
Randomization:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have been in business for at least 2 years in order to demonstrate business stability and minimize participant loss-to-follow-up due to closing of centers.
- •Must be planning to remain in business for at least the next 18 months to ensure our ability to collect follow-up data.
- •Must have at least 4 workers (1 director/assistant director and 3 staff) who are willing to take part in the study and agree to study protocols - participation in three data collection time points, attendance at a kick-off event, and acceptance of random assignment.
- •Center staff must speak and read English.
排除标准
- •been in business for less than 2 years
- •plans to close in the next 18 months
- •director/assistant director unwilling to participate
- •less than 3 child care staff willing to participate
- •child care staff do not read and speak English
研究组 & 干预措施
Control
6-month intervention to educate and improve financial health
干预措施: Healthy Finances (Other)
Intervention
6-month intervention to increase physical activity and improve other health related behaviors
干预措施: Healthy Lifestyles (Behavioral)
结局指标
主要结局
Change in moderate to vigorous physical activity (MVPA)
时间窗: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention
Child care center staff members' MVPA will be assessed using accelerometers. Staff will wear a GT3X+ accelerometer for 7 days, for 24 hours a day (during all waking and sleeping hours), except when bathing or participating in swimming/water activities. Monitors will be programmed to sample acceleration at 30 Hz. Each monitor will be placed onto an adjustable belt that allows the monitor to be worn comfortably over the right hip. Adult cut-points will be applied to calculate minutes of sedentary, light, moderate and vigorous activity. Minutes of moderate to vigorous physical activity (MVPA) will be used as the primary outcome. Monitors will be distributed during the on-site visits to centers so that research assistants can adjust the belt to the appropriate length for each worker.
次要结局
- Change in dietary intake(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in smoking/e-cigarette status(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in sleep quality(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in stress(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in Body Mass Index(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in waist circumference(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in cardiovascular fitness(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in strength(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in endurance(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in balance(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in child care center worksite wellness environment(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)
- Change in teacher physical activity practices(Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention)