Supporting Baby Behavior Through Pediatric Offices
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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Davis、California、アメリカ、95616
- University of California, Davis
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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:
- Will attend a participating pediatric clinic for her well-baby visits
- Primiparous, singleton pregnancy
- Currently enrolled in WIC
- At least 18 years of age
- Speaks and reads English or Spanish
- Has a telephone and access to the internet
- Plans to stay in the area for 6 months after birth of infant
- Abstained from smoking during pregnancy
Exclusion criteria:
- Gave birth before 37 weeks gestation
- She and/or her infant has health condition(s) or known health risks that contraindicate breastfeeding
- She and/or her infant has health condition(s) or known health risks that impact infant growth and development
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:防止
- 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 |
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実験的:Baby Behavior
The intervention is comprised of 2 components: HCP and medical staff training and participant education. The trainings will be video-based and aim to build providers' knowledge and skills to support parents' recognition and understanding of common healthy infant behaviors that may be misinterpreted by parents. The intervention does not include any specific recommendations for infant feeding, nor does it include any information related to the assessment, diagnosis or treatment for any medical condition. After completion of the intervention trainings, health care providers and medical staff will be asked to use what they learned with the mothers of infants in their care. Short handouts for mothers will be provided as tools to reinforce the verbal education. All educational materials will be focused only on supporting parents' abilities to recognize and understand common, healthy infant behaviors. |
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介入なし:Control
The control arm will continue with standard well-baby visit practices during the intervention period and will be offered the option to complete the Baby Behavior online trainings for continuing education credits.
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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 |
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Weight-for-length growth trajectory
時間枠:Up to 6 months postpartum
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Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards
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Up to 6 months postpartum
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Infant feeding practices
時間枠:1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
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Breastfeeding duration and exclusivity, introduction of non-breast milk foods and fluids, use of sugary beverages, and intake of formula and select complementary foods
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1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
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Maternal depressive symptoms
時間枠:2 weeks and 6 months postpartum
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Edinburgh Postnatal Depression Scale
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2 weeks and 6 months postpartum
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Maternal self-efficacy
時間枠:1 week, 2 months, and 6 months postpartum
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Perceived Maternal Parenting Self-Efficacy
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1 week, 2 months, and 6 months postpartum
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Maternal perceived stress
時間枠:1 week, 2 months, and 6 months postpartum
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Perceived Stress Scale Short-Form
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1 week, 2 months, and 6 months postpartum
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Infant sleep patterns
時間枠:2 months and 6 months postpartum
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Brief Infant Sleep Questionnaire
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2 months and 6 months postpartum
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Infant development
時間枠:2 months, 4 months, and 6 months postpartum
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Ages and Stages Questionnaire
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2 months, 4 months, and 6 months postpartum
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Infant eating behavior
時間枠:4 months postpartum
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Baby Eating Behavior Questionnaire
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4 months postpartum
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協力者と研究者
捜査官
- 主任研究者:Jane Heinig, PhD、University of California, Davis
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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。
Baby Behaviorの臨床試験
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Florida State UniversityDuquesne University募集
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Florida International UniversityAcademy of Nutrition and Dietetics募集
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Oregon Center for Applied Science, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)完了