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临床试验/NCT04498845
NCT04498845终止不适用

RECLEAN Pilot Study: Reducing Lead in the Homes of Construction Workers

Boston University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年4月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
35
试验地点
1
主要终点
Blood metal levels from adult household members at 5 months

研究概览

简要总结

This is an exposure assessment pilot study tailored for families of construction workers living with a child. The investigators will compare home dust metal levels and resident's blood metal levels before and after an educational and environmental intervention. A baseline and a post intervention period assessment will be conducted with home and car lead inspections and risk assessments with collection of dust, urine, blood and toenail samples and a survey.

Objectives of this research are to:

  1. To characterize pre-intervention home exposures to lead and other metals in households with one construction worker inhabitant living with a child, by assessing household members' biospecimens and home dust metal levels.
  2. To develop and evaluate customized home interventions (including environmental and educational approaches) to reduce metals exposure in three tiers of intervention.
  3. To characterize home exposures to lead and other metals post intervention and determine adapted behaviors and whether the degree of metals exposure reduction (including take home exposures) in the households depends on the level of intervention.

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
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •First, construction workers will be recruited. Second, household members of the construction worker will be recruited.
  • •Inclusion Criteria:
  • •Construction workers must meet all of the following inclusion criteria:
  • •18 years of age or older
  • •works full time in construction with high risk for metal exposures
  • •lives in the Greater Boston area
  • •lives with at least 1 child household member 1 year of age or older (does not have to be a child of the worker but interested in participating in the study)
  • •speaks English or Spanish.
  • •Household resident participants must meet all of the following inclusion criteria:
  • •child (1 - 17 years of age) or adult (18 years of age or older)
  • •lives in the Greater Boston area with the worker participating in this study
  • •speaks English or Spanish.

排除标准

  • 未提供

研究组 & 干预措施

Intermediate intervention group

Experimental

Participants in the intermediate intervention group will have a 1-hour in-home assessment plan and educational session and refer worker to a 1-hr worker take home prevention educational session.

干预措施: In-home assessment plan (Other)

Basic intervention group

Active Comparator

Participants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session.

干预措施: Family educational session (Behavioral)

Intermediate intervention group

Experimental

Participants in the intermediate intervention group will have a 1-hour in-home assessment plan and educational session and refer worker to a 1-hr worker take home prevention educational session.

干预措施: Family educational session (Behavioral)

Intermediate intervention group

Experimental

Participants in the intermediate intervention group will have a 1-hour in-home assessment plan and educational session and refer worker to a 1-hr worker take home prevention educational session.

干预措施: Worker take home prevention training (Behavioral)

Advanced intervention group

Experimental

Participants in the advanced intervention group will have a 1-hour in-home assessment plan and educational session, refer worker to a 1-hr worker take home prevention educational session, and provision of D-LEAD all-purpose cleaner and laundry detergent.

干预措施: In-home assessment plan (Other)

Advanced intervention group

Experimental

Participants in the advanced intervention group will have a 1-hour in-home assessment plan and educational session, refer worker to a 1-hr worker take home prevention educational session, and provision of D-LEAD all-purpose cleaner and laundry detergent.

干预措施: Family educational session (Behavioral)

Advanced intervention group

Experimental

Participants in the advanced intervention group will have a 1-hour in-home assessment plan and educational session, refer worker to a 1-hr worker take home prevention educational session, and provision of D-LEAD all-purpose cleaner and laundry detergent.

干预措施: Worker take home prevention training (Behavioral)

Advanced intervention group

Experimental

Participants in the advanced intervention group will have a 1-hour in-home assessment plan and educational session, refer worker to a 1-hr worker take home prevention educational session, and provision of D-LEAD all-purpose cleaner and laundry detergent.

干预措施: D-LEAD cleaner products (Other)

Basic intervention group

Active Comparator

Participants in the basic intervention group will have a 1-hour in-home assessment plan and family educational session.

干预措施: In-home assessment plan (Other)

结局指标

主要结局

Blood metal levels from adult household members at 5 months

时间窗: 5 months

During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).

Blood metal levels from construction workers at baseline

时间窗: Baseline, 5 months

During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).

Blood metal levels from construction workers at 5 months

时间窗: Baseline, 5 months

During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).

Change in lead levels in dust from household wiped surfaces

时间窗: Baseline, 5 months

Dust samples will be collected in the home from wiping up to ten 1ft by 1ft surfaces in the home and three wipes in the car following HUD methods from smooth surfaces likely to be contaminated by the worker and that likely expose other family members such as the laundry area, entry walkway, and living room area, as well as areas with potential lead like window sills. Investigators will use SKC 550-002 colorimetric wipe kit for lead on all wipes in order to obtain immediate color response in the presence of lead (reddish color suggests lead). Wipes will be then stored to be sent to the laboratory for quantitative elemental analysis.

Blood metal levels from child household members at 5 months

时间窗: 5 months

During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).

Change in lead levels from household vacuumed dust

时间窗: Baseline, 5 months

Dust samples will be collected by vacuuming the entire home floors and surfaces into a clean sampling thimble. Participants will be asked not to vacuum the house, if possible, at least one week prior to the scheduled home visit, tso that enough dust is available for testing.

Blood metal levels from adult household members at baseline

时间窗: Baseline

During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).

Blood metal levels from child household members at baseline

时间窗: Baseline

During each home visit, a blood sample will be collected from each participant. The frozen blood samples will be sent to the CDC metals laboratory for analysis. Blood will be analyzed using CDC Method for blood multi-element panel, which includes cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg).

次要结局

  • Change in workers' knowledge about household lead exposure(Baseline, 1 hour after worker educational session)
  • Change in behaviors of household members(1 month, 5 months)
  • Change in household members' knowledge about lead exposure(Baseline, 1 hour after in-home family educational session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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