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治験 NCT07114991（対象：Obesity &Amp; Overweight、Sedentary Behaviors、心代謝リスク、身体不活動）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。 | ||
フィルター基準に一致する試験が1件見つかりました
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E-Bike Commuting and Health in Overweight College Students
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 NCT07114991 は 介入研究 臨床試験 で、Obesity &Amp; Overweight、Sedentary Behaviors、心代謝リスク、身体不活動 に関するものです。現在は 実施中／登録終了 で、2025年5月1日 から開始しています。60 名の参加者 の募集が計画されています。この治験は University of Wisconsin, River Falls によって主催され、2026年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年8月11日 です。
概要
This study will evaluate the effects of using a pedal-assist electric bicycle (e-bike) for commuting on physical activity, fitness, and health in overweight or obese college students. Participants will be randomly assigned to either a 12-week e-bike commuting intervention or a control group. The study will measure changes in cardiorespiratory fitness, body composition, blood biomarkers, physical activity, and psychological well-being over a 24-week period.
詳細説明
This randomized controlled trial investigates the effectiveness of e-bike commuting as a strategy to improve cardiometabolic health, physical activity levels, and psychological well-being in college students with a body mass index (BMI) of 25 kg/m² or higher. Eligible participants will be randomized to either a 12-week e-bike intervention group or a control group that continues usual commuting habits. Assessments will occur at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). Each assessment will include VO₂peak testing using a graded cycle ergometer protocol, body composition assessment via BodPod, fasting fingerstick blood tests for glucose, cholesterol, and triglycerides, blood pressure and resting heart rate measurement, and self-report questionnaires evaluating motivation, stress, affect, mental health, and academic engagement. Participants will also complete a 30-minute submaximal cycling test during which affective responses will be recorded, and physical activity will be tracked over 7 days. Those assigned to the intervention group will receive a pedal-assist e-bike, helmet, and safety training and will be asked to ride at least four days per week for 12 weeks. The study aims to determine whether e-bike commuting can promote sustained physical activity and improve cardiometabolic and mental health outcomes in a population at risk for early health decline.
公式タイトル
Effects of Pedal-Assist E-Bike Commuting on Cardiometabolic Health, Physical Activity, and Psychological Well-Being in Overweight College Students
疾患／病気
Obesity &Amp; OverweightSedentary Behaviors心代謝リスク身体不活動刊行物
この臨床試験について発表された科学記事と研究論文：- Peterman JE, Morris KL, Kram R, Byrnes WC. Pedelecs as a physically active transportation mode. Eur J Appl Physiol. 2016 Aug;116(8):1565-73. doi: 10.1007/s00421-016-3408-9. Epub 2016 Jun 14.
- Berntsen S, Malnes L, Langaker A, Bere E. Physical activity when riding an electric assisted bicycle. Int J Behav Nutr Phys Act. 2017 Apr 26;14(1):55. doi: 10.1186/s12966-017-0513-z.
- Johnson L, O'Hara BJ, Phongsavan P, et al. Exploring the feasibility of a 6-week electric-bike intervention with behavioural support in Australia. International Journal of Environmental Research and Public Health. 2021;18(16):8684
- Bourne JE, Sauchelli S, Perry R, Page A, Leary S, England C, Cooper AR. Health benefits of electrically-assisted cycling: a systematic review. Int J Behav Nutr Phys Act. 2018 Nov 21;15(1):116. doi: 10.1186/s12966-018-0751-8.
その他の研究識別子
- 2025-101
NCT番号
開始日
2025-05-01
最終更新日
2025-08-11
終了予定日
2026-06-30
目標参加者数
60
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
Electric bicycle
Active commuting
Exercise motivation
Health behavior
Physical activity
Overweight
Active commuting
Exercise motivation
Health behavior
Physical activity
Overweight
主目的
基礎研究
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 |
|---|---|
実験的Experimental Group Participants in this group will receive a pedal-assist electric bicycle (e-bike), helmet, safety training, and cycling computer. They will be instructed to use the e-bike for commuting or transportation at least four days per week for 12 weeks. They will also complete assessments at baseline, Week 12, and Week 24, including fitness testing, body composition, blood testing, surveys, and activity monitoring. | E-bike Commuting Participants in the intervention group will receive a pedal-assist electric bicycle (e-bike), a helmet, safety training, and a cycling computer. They will be asked to use the e-bike for commuting or personal travel at least four times per week for 12 weeks. E-bike usage will be monitored using a Garmin Edge device. Participants will also complete baseline, 12-week, and 24-week assessments including fitness testing, blood tests, body composition, surveys, and wearable activity monitoring. |
非介入Control Group Participants in the control group will maintain their usual commuting and physical activity habits for the 12-week intervention period. They will complete the same assessments as the intervention group at baseline, Week 12, and Week 24. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in daily moderate-to-vigorous physical activity (minutes/day) | Physical activity will be measured using a hip-worn ActiGraph GT3X+ accelerometer over 7 consecutive days at baseline, Week 12, and Week 24. The device will be analyzed using validated cut points to determine average daily time spent in moderate-to-vigorous physical activity (MVPA). The primary outcome is the change in MVPA from baseline to Week 24 | From enrollment to end of study at 24 weeks. |
Change in cardiorespiratory fitness (VO₂peak, mL/kg/min) | Cardiorespiratory fitness will be measured via a graded cycling test using a metabolic cart to determine peak oxygen uptake (VO₂peak). Participants will complete the test at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). The primary comparison will be the change in VO₂peak from baseline to Week 12 between the intervention and control groups. | From enrollment to end of study at 24 weeks. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in body fat percentage | Body composition will be assessed using air displacement plethysmography (BodPod®). Percent body fat will be calculated at baseline, Week 12, and Week 24. | From enrollment to end of study at 24 weeks. |
Change in total cholesterol, HDL-C, LDL-C, and triglycerides (mg/dL) | Fasting lipid profiles will be assessed at baseline, Week 12, and Week 24 via fingerstick blood sample. Changes in total cholesterol, HDL, LDL, and triglycerides will be evaluated to assess cardiometabolic risk. | From enrollment to end of study at 24 weeks. |
Change in fasting blood glucose (mg/dL) | Fasting blood glucose will be collected via fingerstick and analyzed using a portable blood analyzer. Values will be compared between baseline, Week 12, and Week 24 to determine the impact of the e-bike intervention on glucose regulation. | From enrollment to end of study at 24 weeks. |
Change in exercise motivation (BREQ-3 score) | Exercise motivation will be assessed using the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3) at all three time points. Subscale scores (e.g., intrinsic motivation, external regulation) will be analyzed for changes between baseline, Week 12, and Week 24. | From enrollment to end of study at 24 weeks. |
適格基準
対象年齢
成人
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
- Aged 18-29 years
- Currently enrolled undergraduate or graduate student
- Body mass index (BMI) ≥25.0 kg/m² (classified as overweight or obese)
- Self-report of engaging in <150 minutes per week of moderate-to-vigorous physical activity
- Able and willing to safely ride a bicycle for commuting or transportation purposes
- Willing to be randomized and complete all study procedures across 24 weeks Able to provide informed consent
- Current use of a bicycle or e-bike for commuting ≥2 times per week
- Known cardiovascular, metabolic, or orthopedic conditions that limit physical activity or make exercise testing unsafe
- Currently pregnant, planning pregnancy during the study period, or less than 6 months postpartum
- Use of medications known to affect glucose metabolism, heart rate, or physical activity (e.g., beta-blockers, insulin)
- Diagnosed severe mental health disorders that would impair study participation
- Participation in another clinical trial or lifestyle intervention within the past 3 months
- Inability or unwillingness to attend lab visits or comply with the intervention protocol
University of Wisconsin, River Falls責任者
Gregory Ruegsegger, 研究責任者, Professor, University of Wisconsin, River Falls
連絡先情報がありません。
1 1カ国の場所
Wisconsin
University of Wisconsin-River Falls, River Falls, Wisconsin, 54022, United States