Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 635
- 试验地点
- 15
- 主要终点
- Change in Fuster-BEWAT Score
研究概览
简要总结
Two Intensive Life Style Intervention Programs in Related Caregivers of Preschool Children
Substantial strides have been made in the treatment of acute cardiovascular conditions, such as myocardial infarction and stroke, however, the global burden of cardiovascular disease (CVD) continues to rise at an alarming rate. Furthermore, despite the abundant data demonstrating a greater burden of CVD in racial/ethnic minorities, and many specific interventions aimed at changing risk factor patterns or behaviors in racial/ethnic minorities, health disparities persist. In the present study, the investigators seek to evaluate the impact of a multifaceted and comprehensive lifestyle intervention coupled with atherosclerosis imaging on reducing cardiovascular risk among minority adults living in Harlem, New York. The investigators believe that holistic, multi-dimensional individual and peer-to-peer intensive lifestyle interventions involving parents/caregivers of preschool children will be effective in producing favorable change in their behaviors, which will be sustained over time. The primary hypothesis of the study is that aggressive lifestyle interventions will be more effective in improving healthy behaviors and biological correlates in at-risk adult parents and/or caregivers of preschool children in Harlem, NY. In aim 1, as an initial pilot study, the investigators will identify the contextual factors, facilitators and barriers that may impact the implementation of a lifestyle intervention program for adults in Harlem, using qualitative research methods. In aim 2, the investigators will determine the impact of two intensive lifestyle interventions on promoting and improving healthy behaviors and biological parameters to lower cardiovascular risk, the impact of the knowledge of presence of atherosclerosis on health behaviors and the impact of these lifestyle interventions on atherosclerosis among approximately 600 asymptomatic at-risk adults. Finally, in aim 3, the investigators will evaluate the sustainability of the impact of the two intensive lifestyle interventions on healthy behaviors and biological parameters approximately 12 months after the intervention program ends.
详细描述
Aim 1 - Pilot: To identify the contextual factors, facilitators and barriers that may impact the implementation of a lifestyle intervention program for adults in Harlem, using qualitative research methods: 1) focus group discussions among a representative cohort of adults; 2) focus group discussions among community leaders; and 3) Pilot studies of feasibility of interventions in the representative cohort of adults.
Subsidiary Aim 1.1: To use identified facilitators and barriers to develop a contextually and culturally appropriate model for an adult lifestyle intervention program.
Subsidiary Aim 1.2: To implement a pilot intervention of the contextually and culturally adapted program among a sample of parents/caregivers of children in preschools in Harlem.
The investigators will assess for acceptability and feasibility, and make any necessary modifications prior to the implementation of the cluster-randomized trial. This aim will be carried out at 2 preschools in Harlem, NY by including the parents and caregivers of pre-school children. The final intervention program that results from this intervention-mapping program will be piloted in parent groups of 8-10.
Aim 2 - Randomization: To determine (i) the impact of two intensive lifestyle interventions on promoting and improving healthy behaviors (increased physical activity, smoking cessation etc.) and biological parameters (lipids, sugar) to lower cardiovascular risk, (ii) the impact of the presence of atherosclerosis on health behaviors and (iii) the impact of the lifestyle interventions on atherosclerosis among approximately 600 asymptomatic at-risk adults.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents and caretakers of children attending 15 preschools that will be comparable in characteristics related to socio-economic level and ethnicity.
- •The schools must be located in Harlem, NY.
- •The schools must be public.
- •The schools must have children 3, 4 and 5 years of age.
- •The schools must provide meals for the children.
- •The schools must make available use of their applicable program operation space.
- •Adult parents and/or caregivers of children enrolled in the FAMILIA children's study will be approached for participation in this study.
排除标准
- •Participation in any other major structured health intervention program similar to the FAMILIA Program during the evaluation of the program.
- •Inability to carry out all activities proposed by the FAMILIA Program.
结局指标
主要结局
Change in Fuster-BEWAT Score
时间窗: baseline and 12 months
BEWAT stands for Blood pressure, Exercise, Weight, Alimentation (diet) and Tobacco (smoking). Change in Fuster-BEWAT score at 12 months as compared to baseline. The overall BEWAT scale ranges from 0 (poor health) to 15 (ideal cardiovascular health). Higher score indicates healthier outcomes.
次要结局
- Change in IPAQ(baseline and 24 months)
- Change in Fuster-BEWAT Score(Baseline and 24 months)
- Change in individual domains assimilated in the composite Fuster-BEWAT Score(Baseline and 24 months)
- Change in Blood Pressure(baseline and 24 months)
- Change in blood lipid profile(baseline and 24 months)
- Change in blood glucose(baseline and 24 months)
- Change in plaque volume(baseline and 12 months)