鉛曝露介入プログラム (LEIP)
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
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Karen Jansen
- 電話番号:206-685-6392
- メール:kjansen@uw.edu
研究場所
-
-
-
Nairobi、ケニア
- Dandora and Baba Ndogo Health Centres
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
-Parent unwilling to be contacted for the purposes of tracing and follow-up
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Immediate messages
Caregivers of children with elevated blood lead levels will be provided with immediate messages about lead risk mitigation in the clinic setting. They will receive follow-up at 3 months and 9 months and will complete recall, behavior, and recheck questionnaires and their children will have BLL rechecks. |
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. |
|
実験的:Home visit
Caregivers of children with elevated blood lead levels will be provided with immediate messages about lead risk mitigation in the clinic setting. They will also receive a home observation visit and have those risk reduction methods reiterated and tailored to their home situation. They will receive follow-up at 3 months and 9 months and will complete recall, behavior, and recheck questionnaires and their children will have BLL rechecks. |
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. 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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recall of survey risk factors
時間枠:3 and 9 months post clinic visit
|
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). |
3 and 9 months post clinic visit
|
|
Self report of risk-reduction behavior
時間枠:3 and 9 months post clinic visit
|
Assess the proportion of caregivers self-reporting uptake of at least one of their risk reduction recommendations within arms and by BLL. |
3 and 9 months post clinic visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Differences in outcomes between arms
時間枠:3 and 9 months post clinic visit
|
Using risk survey responses and self-reported changes in risk reduction behavior, we will compare the participants of both arms to assess for differences. |
3 and 9 months post clinic visit
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Uptake of the BLL re-check
時間枠:3 and 9 months post-initial visit
|
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. |
3 and 9 months post-initial visit
|
|
Change in BLL
時間枠:3 and 9 months post-initial clinic visit
|
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. |
3 and 9 months post-initial clinic visit
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Sarah Benki-Nugent、University of Washington
出版物と役立つリンク
一般刊行物
- Onoh I, Mugo C, Riederer A, Maleche-Obimbo E, Were FH, Loftus C, Mukumbang F, Lumumba E, Richardson B, Edemba PW, Mutai BC, Karr C, Benki-Nugent S. Adapting, piloting, and evaluating a pediatric lead screening and risk-reduction intervention in Nairobi: A hybrid implementation-effectiveness trial protocol. PLoS One. 2026 Jun 4;21(6):e0349153. doi: 10.1371/journal.pone.0349153. eCollection 2026.
- Onoh I, Mugo C, Riederer A, Maleche-Obimbo E, Were FH, Loftus C, Mukumbang F, Lumumba E, Richardson B, Edemba PW, Mutai BC, Karr C, Benki-Nugent S. Adapting, piloting, and evaluating a pediatric lead screening and risk-reduction intervention in Nairobi: A hybrid implementation-effectiveness trial protocol. medRxiv [Preprint]. 2026 Apr 30:2026.04.28.26351918. doi: 10.64898/2026.04.28.26351918.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- STUDY00022114
- 1R01ES036010 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
All data other than patient direct or indirect identifiers will be shared.
IPD 共有アクセス基準
Other researchers can contact the MPIs and complete an approved Data Sharing Agreement
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。