Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers
2019年4月22日 更新者：Children's Hospital of Philadelphia
Home Plate: A Randomized Controlled Trial of a Community-Engaged Intervention to Improve Home Food Preparation Practices and Health During Early Childhood
This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children.
調査の概要
詳細な説明
Barriers to healthy eating and active living are at the heart of the obesity epidemic. This study focuses on a key factor underlying healthy eating: home food preparation. This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children. The investigators will partner with community-based organizations serving families with children ages 1 to 3 years in West Philadelphia aiming specifically to:
Test the intervention's effect on diet and physical health.
Hypothesis 1: The intervention group will have improved home food preparation practices and a healthier diet compared to the control group.
Test the intervention's effect on family health.
Hypothesis 2: The intervention group will report improved parenting skills and more hopeful patterns of thinking.
- Identify factors present at baseline and during engagement with the intervention that distinguish intervention participants who have improved diet, physical health, and family health from those who do not.
研究の種類
介入
入学 (実際)
115
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
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
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria: mentees
- English-speaking
- Able to give informed consent.
- Legal guardian and caregiver of at least one child, age 1-3 years
Inclusion Criteria: children
- 1-3 year old children of mentee primary caregivers enrolled in the study
- If a mentee caregiver has more than one child, then all their eligible children (ages 1-3 years) will be enrolled in the study.
Inclusion Criteria: peer mentors
Eligible peer mentors should meet the inclusion criteria set forth above for mentees. (Children of peer mentors will not be eligible for this study.)
In addition,
- The study team will decide which participants will be invited to be peer mentors, based on attributes including interest, leadership ability, and home food preparation skills.
Exclusion Criteria
- Caregivers and children not meeting the inclusion criteria above.
- Caregivers who are pregnant at the time of enrollment.
- Caregivers or children with a medical condition that significantly affects their diet or eating habits. (The study team will ask during the time of recruitment if subjects or their children have a medical condition that significantly affects diet or eating habits.)
- Subjects who, in the opinion of the Investigator, may be unable to participate in the study schedules or procedures.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：Intervention
Behavioral: Home Plate intervention
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Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children.
Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.
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実験的：Delayed Entry Control
This Arm will receive the Home Plate intervention 3 months after the Intervention Arm completes the intervention.
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Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children.
Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.
|
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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Dietary Energy Density (Child Participants)
時間枠：19-30 weeks from baseline
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Child participants' 24-hour dietary recalls will be collected by trained study staff from adult caregivers.
24-hour dietary recalls will be collected on a minimum of 2 and a maximum of 3 separate days.
The results will then be used to calculate the energy density of the child's diet.
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19-30 weeks from baseline
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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 |
|---|---|---|
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Home Food Preparation Practices
時間枠：19-30 weeks from baseline
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Adult participants will complete surveys to assess the foods they usually prepare at home, as well as the time, energy, and confidence they have to prepare meals for their household.
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19-30 weeks from baseline
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Home Food Environment
時間枠：19-30 weeks from baseline
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Adult participants will complete surveys to assess the foods currently available in their homes, how they feel about managing food-related tasks, and the interactions they have with their child(ren) regarding food and eating.
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19-30 weeks from baseline
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Household Routines
時間枠：19-30 weeks from baseline
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Adult participants will complete surveys to assess their household routines related to activities such as sleep, physical activity, and screen time.
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19-30 weeks from baseline
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Emotional and Family Health
時間枠：19-30 weeks from baseline
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Adult participants will complete surveys to assess the their emotional health and the health of their families.
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19-30 weeks from baseline
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Body mass index
時間枠：19-30 weeks from baseline
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Heights and weights will be measured by trained study staff and will be used to calculate body mass index (BMI) of adult and child participants.
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19-30 weeks from baseline
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Dietary Energy Density (Adult Participants)
時間枠：19-30 weeks from baseline
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24-hour dietary recalls will be collected by trained study staff from adult study participants.
24-hour dietary recalls will be collected on a minimum of 2 and a maximum of 3 separate days.
The results will then be used to calculate dietary energy density.
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19-30 weeks from baseline
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Diet Quality
時間枠：19-30 weeks from baseline
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In addition to dietary energy density, 24-hour dietary recall data will be used to calculate both child and adult study participants' intake of fruits, vegetables, whole grains, and added sugars.
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19-30 weeks from baseline
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年6月1日
一次修了 (実際)
2017年7月1日
研究の完了 (実際)
2017年7月13日
試験登録日
最初に提出
2015年5月28日
QC基準を満たした最初の提出物
2015年5月29日
最初の投稿 (見積もり)
2015年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月24日
QC基準を満たした最後の更新が送信されました
2019年4月22日
最終確認日
2019年4月1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。
Home Plateの臨床試験
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Orthofix s.r.l.完了関節疾患 | ゲン・ヴァルム | Genu Valgum | 膝の変形 | 足首の変形 | 長さの不平等、脚 | 不一致の長さ;先天性 | 四肢の変形イタリア
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University of Missouri-ColumbiaCarboFix Orthopedics Ltd.募集
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ReVivo Medical, Corp.The Cleveland Clinic; Albany Medical College; IGEA募集首の痛み | 脊椎症 | ミエロパシーを伴う脊椎症 | 神経根症を伴う脊椎症 | 神経根症を伴う脊椎症 頸部領域 | 椎間板障害 子宮頸部アメリカ
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Centre Hospitalier Universitaire de Saint EtienneAssociation pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire完了
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University of North Carolina, Chapel HillNational Institute of Nursing Research (NINR)募集
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University Health Network, TorontoSunnybrook Health Sciences Centre; University of Toronto完了