Lead Exposure Intervention Program

ConditionsLead Exposure High Blood Lead Level

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-72

SponsorUniversity of Washington

About this trial

The goal of this clinical trial is to learn if BLL (blood lead level) screening and "healthy home" lead prevention program created in the US is adaptable to a Sub-Saharan African context. It will also work to address child lead exposure in Nairobi, Kenya. The main questions it aims to answer is:

* Can materials and protocols developed for a US audience be effective in a Sub-Saharan African one? * Is there a difference in learning and action between groups that receive different degrees of intervention?

Researchers will compare the outcomes of a group that received lead risk reduction information only in the clinical setting to a group that also received a home visit and tailored risk reduction messages.

Participants will:

* Have their child's blood lead levels measured at several timepoints * Take part in a questionnaire about lead risk * Receive lead risk reduction messaging either only in the clinic setting or also in their homes * Have their knowledge and risk reduction behaviors measured

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Child age 12-72 months

Parent or primary caregiver that is a biological relative is available to give informed consent for LEIP study

Parent/caregiver is 18 years of age or older or is an emancipated minor

Parent available for 9 months follow-up

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Home visit with tailored messages
Behavioral
The home visit will be conducted within 2 weeks of initial screening. During the home visit, the lead exposure risk survey will be re-administered, for comparison to in-clinic self-report survey responses. In addition, an observational checklist of potential lead exposure risk factors will be conducted to identify and discuss residential features and items in the home environment that may be influencing their BLL. Tailored messages on lead exposure risk reduction will be provided. A random sample of caregivers will complete an in-depth interview to gather barriers, understandability, and acceptability of the lead risk reduction messages received.
In-clinic lead risk reduction intervention
Behavioral
For children with BLL \< 5 ug/dL, the result will be provided to the caregiver, together with standard post-test messaging on reducing lead exposure. A job-aid, such as a poster, showing common sources of lead exposure in children, and important sources of iron rich foods will be used to guide messaging. For BLLs ≥ 5, tailored messaging on potential sources identified on the risk factor survey will be provided. A random sample of caregivers will complete an in-depth interview to gather barriers, understandability, and acceptability of the lead risk reduction messages received.

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: Immediate messagesActive comparator 1 intervention

Group B: Home visitExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Recall of survey risk factors

Lead risk surveys will be completed by participants during the clinic visit and at 3 and 9 months post home visit. Qualitative analysis of the lead risk survey will summarize themes on understandability and acceptability of survey items and messages. The rapid analysis will also explore facilitators and barriers to uptake of recommended exposure reduction measures, and individual level determinants associated with uptake (e.g., empowerment, self-efficacy).

Time frame

3 and 9 months post clinic visit

Self report of risk-reduction behavior

Assess the proportion of caregivers self-reporting uptake of at least one of their risk reduction recommendations within arms and by BLL.

Time frame

3 and 9 months post clinic visit

Secondary outcomes

Differences in outcomes between arms

Using risk survey responses and self-reported changes in risk reduction behavior, we will compare the participants of both arms to assess for differences.

Time frame

3 and 9 months post clinic visit

Other outcomes

Uptake of the BLL re-check

Return for a re-check visit is an indicator of caregiver awareness of importance of reducing lead exposure. We will summarize the proportions of caregivers returning for each BLL re-check visit for each arm.

Time frame

3 and 9 months post-initial visit

Change in BLL

Change in BLL at re-checks. We do not anticipate observing a significant reduction in child BLL, given that caregivers might not have the ability to identify and/or modify a lead risk exposure.

Time frame

3 and 9 months post-initial clinic visit

Sponsors and contacts

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University of Washington

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Source ClinicalTrials.gov

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