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治験 NCT05677906（対象：身体活動）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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オレゴン健康科学大学Rural Libraries Promoting Walking and Walkability in Their Rural Communities
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05677906 は 身体活動 に関する 予防 の研究で、第I相・第一段階 第II相・第二段階 介入研究 臨床試験 です。現在は 実施中／登録終了 で、2023年4月25日 から開始しています。331 名の参加者 の募集が計画されています。この治験は オレゴン健康科学大学 によって主催され、2025年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年1月16日 です。
概要
The investigators will randomize 20 rural libraries to implement either a group-based walking (standard approach) or a group-based walking combined with a civic engagement program (combined approach). Each rural library will enroll between 15-20 participants. The investigators will compare the change in physical activity between participants in each group.
詳細説明
The goals of this study are:
- Increase the capacity of rural libraries to deliver evidence-based health promotion programs
- Compare the effects of a group-based walking program with a combined group-based plus civic engagement program on physical activity, cardiovascular fitness and collective efficacy among rural residents.
- Evaluate program implementation
公式タイトル
Rural Libraries Promoting Walking and Walkability in Their Rural Communities
疾患／病気
身体活動刊行物
この臨床試験について発表された科学記事と研究論文：- Lenstra N. The role of public librarians in supporting physical activity: challenging the "Jacks of All Trades but Masters of None" librarian syndrome. Advances in Library Administration and Organization. 2018;39:185-205.
- Perry CK, Campbell LP, Currier J, Farris PE, Wenzel ES, Medysky ME, Zell A, McDonell M, Shannon J, Winters-Stone K. An Evidence-Based Walking Program in Oregon Communities: Step It Up! Survivors. Prev Chronic Dis. 2020 Dec 10;17:E156. doi: 10.5888/pcd17.200231.
- Seguin RA, Sriram U, Connor LM, Silver AE, Niu B, Bartholomew AN. A Civic Engagement Approach to Encourage Healthy Eating and Active Living in Rural Towns: The HEART Club Pilot Project. Am J Health Promot. 2018 Sep;32(7):1591-1601. doi: 10.1177/0890117117748122. Epub 2018 Feb 1.
- Perry CK, Seguin-Fowler R, Maddock JE, Lenstra N, Dieckmann NF, Currier J, Andreyeva E, Winkle J, Trost SG. Rural libraries implementing walking groups or walking groups plus civic engagement for walkability in rural communities: a comparative effectiveness trial study protocol. BMC Public Health. 2023 Oct 2;23(1):1895. doi: 10.1186/s12889-023-16788-0.
その他の研究識別子
- STUDY00024665
NCT番号
開始日
2023-04-25
最終更新日
2024-01-16
終了予定日
2025-12-31
目標参加者数
331
試験の種類
介入研究
治験の相・段階
第I相・第一段階
第II相・第二段階
第II相・第二段階
状況
実施中／登録終了
キーワード
rural populations
physical activity promotion
physical activity promotion
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬Walking only (Step It Up!) A group-based, weekly walking program (Step It Up) where participants walk for up to 45 minutes. | Walking ONLY (Step it up!) Participants will meet weekly for 60 minutes and walk together as a group. Participants will progressively build up to walking for 45 minutes at a brisk pace. Walks will start with a check-in and end with stretching as a group. |
実験的Combined (Step It Up! plus Change Club) A group-based, weekly walking program (Step It Up) where participants walk for up to 45 minutes. Participants also spend 30 minutes each week in a civic engagement program (the Change Club) improving walkability in the community | Walking ONLY (Step it up!) Participants will meet weekly for 60 minutes and walk together as a group. Participants will progressively build up to walking for 45 minutes at a brisk pace. Walks will start with a check-in and end with stretching as a group. Combined (Step it up! Plus Civic Engagement) Participants in the combined groups will meet weekly for 90 minutes with group members. They will participate in a group walk for 60 minutes followed by 30 minutes of civic engagement aimed at improving walkability in the community |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Physical activity | Participants will be asked to wear an accelerometer for \>10 hours/day for seven days at the wrist to measure physical activity. An accelerometer is a small device worn at the wrist that records acceleration, the change in velocity of a participant over time. | Change from baseline physical activity at 6 months, 12 months, and 24 months. |
Cardio respiratory fitness | Participants will be asked to complete a six-minute walk test to measure cardiorespiratory fitness. The distance walked in 6 minutes will be recorded. | Change from baseline cardio respiratory fitness at 6 months, 12 months, and 24 months. |
Collective Efficacy | Participants will be asked to complete a survey regarding collective-efficacy, the Collective Efficacy Scale (Sampson and colleagues, 1997), which measures how well communities work together to make things happen. | Change from baseline collective efficacy at 6 months, 12 months, and 24 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Height | Researchers will measure the height of participants in inches. | Baseline |
Hip circumference | Researchers will measure the hip circumference of participants in inches. | Change from baseline hip circumference at 6 months, 12 months, and 24 months. |
Resting heart rate | Researchers will measure resting heart rate of participants by using heart rate monitor. | Change from baseline resting heart rate at 6 months, 12 months, and 24 months. |
Weight | Researchers will measure the weight of participants in pounds. | Change from baseline weight at 6 months, 12 months, and 24 months. |
Blood pressure | Researchers will measure the both diastolic and systolic blood pressure of participants using a sphygmomanometer. | Change from baseline blood pressure at 6 months, 12 months, and 24 months. |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Age 18 or older
- Inactive (defined as engaging in physical activity <3 days per week)
- Ability to walk for at least 20 minutes
- Living within the rural community served by the local library
- Ability to travel to the local library/location of walking group.
- Participation/intention to participate in other lifestyle modification pro-gram(s)
- Cognitive impairment
- Inability to communicate due to severe uncorrected hearing loss or speech disorder or severe visual impairment (if precludes completion of assessments and/or intervention)
オレゴン健康科学大学237 件のアクティブな治験を探索- Texas A&M University
- University of North Carolina, Greensboro
連絡先情報がありません。
1 1カ国の場所
Oregon
Oregon Health & Science University, Portland, Oregon, 97239, United States