Healthy Growth Abbreviated Pilot Study
Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
調査の概要
詳細な説明
This novel intervention, delivered to mothers primarily through private Facebook groups, will promote behavior change through peer and self-modeling photo/video activities.
In this study, we will implement an abbreviated 2-month version of the intervention with a single peer group of up to 10 mothers. We will assess the feasibility and acceptability of both the intervention and our intended outcome measures, in preparation for a randomized pilot trial of the full intervention.
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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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- The Children'S Hospital Of Philadelphia
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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:
- Women age 18 years and older
- Enrolled in Medicaid at the time of study enrollment
- Overweight or obese (BMI >= 25, calculated using self-reported pre-pregnancy height and weight)
- Subjects able to speak, read and write in English
- Attend their infant's (up to 1 month old) primary care visit at a CHOP Primary Care Network site
- Received prenatal care
- Own a smartphone with both a data and text plan
- Able to use their phone to obtain photographs and videos prior to enrollment
Exclusion Criteria:
- Cannot provide consent.
- Non-English speaking.
- Score 10 or greater on Patient Health Questionnaire (PHQ-9) measure for clinical depression
- Diagnosed with gestational diabetes during pregnancy with their newborn
- Had a multiple pregnancy.
- Premature delivery (before 37 weeks) of their newborn.
- Have a newborn who was hospitalized in the Neonatal Intensive Care Unit (NICU) for one week or longer.
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:なし
- 介入モデル:単一グループの割り当て
- 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:Pilot Intervention Group
Mothers who are screened and determined to be eligible for this single-group pilot study will be enrolled along with their infants in the Grow Together peer group intervention.
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Participants in this intervention will:
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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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Intervention Acceptability Survey
時間枠:Study end (approximately 2 months)
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Satisfaction with the overall intervention will be assessed for mothers using a standard survey.
Subjects will be asked a series of open-ended and Likert-scaled questions.
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Study end (approximately 2 months)
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Study population eligibility and interest
時間枠:Study end (approximately 2 months)
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These proportions will be calculated using study recruitment records. |
Study end (approximately 2 months)
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Participant engagement
時間枠:Study end (approximately 2 months)
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This study process data will be obtained from the Facebook group and study records at study end. |
Study end (approximately 2 months)
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Week 1 Curriculum Module Acceptability Survey
時間枠:1 week (approximately)
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Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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1 week (approximately)
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Week 2 Curriculum Module Acceptability Survey
時間枠:2 weeks (approximately)
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Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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2 weeks (approximately)
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Week 3 Curriculum Module Acceptability Survey
時間枠:3 weeks (approximately)
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Subjects will assess the Week 3 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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3 weeks (approximately)
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Week 4 Curriculum Module Acceptability Survey
時間枠:4 weeks (approximately)
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Subjects will assess the Week 4 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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4 weeks (approximately)
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Week 5 Curriculum Module Acceptability Survey
時間枠:5 weeks (approximately)
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Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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5 weeks (approximately)
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Week 6 Curriculum Module Acceptability Survey
時間枠:6 weeks (approximately)
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Subjects will assess the Week 6 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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6 weeks (approximately)
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Week 7 Curriculum Module Acceptability Survey
時間枠:7 weeks (approximately)
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Subjects will assess the Week 7 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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7 weeks (approximately)
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Week 8 Curriculum Module Acceptability Survey
時間枠:8 weeks (approximately)
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Subjects will assess the Week 8 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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8 weeks (approximately)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Infant feeding beliefs
時間枠:Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Maternal beliefs regarding infant feeding will be measured using the Infant Feeding Style Questionnaire (IFSQ), which contains 10 items measuring beliefs, coded on a 5-point scale (disagree, slightly disagree, neutral, slightly agree, agree).
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Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Infant feeding practices
時間枠:Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Maternal behaviors related to infant feeding will be measured using 10 items on the Infant Feeding Style Questionnaire (IFSQ). Behavior items are coded on a 5-point scale (never, seldom, half of the time, most of the time, always). Also, four items from the validated Infant Feeding Practices Questionnaire (IFPQ) will be used to assess maternal feeding practices related to obesity. The IFPQ contains 20 items, with a 5-point adapted Likert response scale ranging from 0 (Never) to 4 (Always). |
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Breastfeeding survey
時間枠:Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Breastfeeding intent, initiation, and duration will be assessed using a survey
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Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Introduction of solid foods and sugar-sweetened beverages
時間枠:Study end (approximately 8 weeks)
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Timing of initiation of solid foods and sugar sweetened beverages will be assessed using a survey.
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Study end (approximately 8 weeks)
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Infant sleep behaviors
時間枠:Study end (approximately 8 weeks)
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Infant sleeping and related maternal activities will be measured using the validated Brief Infant Sleep Questionnaire (BISQ).
Subjects will complete the abbreviated 13-item BISQ (A-BISQ), as well as 2 additional questions from the expanded version (E-BISQ).
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Study end (approximately 8 weeks)
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Parenting self-efficacy
時間枠:Study end (approximately 8 weeks)
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The Karitane Parenting Confidence Scale (KPCS) is a 15-item validated scale that will be used to measure parenting self-efficacy.
Questions assess the frequency of certain beliefs, skills and abilities related to successful parenting, measured using a 4-point response structure (No, hardly ever; No, not very often; Yes, some of the time; Yes, most of the time).
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Study end (approximately 8 weeks)
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Positive parenting behaviors
時間枠:Study end (approximately 8 weeks)
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Mothers will be assessed regarding specific parenting practices using the 10-item Infant/Toddler (IT) Home Observation for Measurement of the Environment (HOME) Inventory.
Individual responses for each yes/no item are coded to 0 or 1.
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Study end (approximately 8 weeks)
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Maternal self-care behaviors
時間枠:Study end (approximately 8 weeks)
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Mothers will be asked 11 questions related to their self-care behaviors, including their own sleep habits, support-seeking behaviors, and taking time for themselves.
These items are a combination of Likert-scaled items and simple measures of the frequency of behaviors.
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Study end (approximately 8 weeks)
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Maternal social support
時間枠:Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Mothers' level of social support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS).
This validated scale is made up of 12 items.
Responses for this scale are coded from 1 to 7 (very strongly disagree, strongly disagree, mildly disagree, neutral, mildly agree, strongly agree, and very strongly agree).
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Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Maternal stress
時間枠:Study end (approximately 8 weeks)
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The Parental Stress Scale (PSS) is a validated, 18-item public domain scale measuring perceived parental stress using a 5-point Likert rating scale ('Strongly disagree' to 'strongly agree').
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Study end (approximately 8 weeks)
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Infant weight and growth
時間枠:Study start (enrollment visit) and study end (approximately 8 weeks)
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Infants' weight will be measured using using a calibrated digital scale and length will be measured using a standard infantometer.
Measurements will be taken by a trained nurse or other trained staff member at the primary care recruitment sites, or by a member of the study staff trained in anthropometric measures.
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Study start (enrollment visit) and study end (approximately 8 weeks)
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協力者と研究者
捜査官
- 主任研究者:Alexander G Fiks, MD, MSCE、Children's Hospital of Philadelphia
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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