Evaluating the Feasibility and Acceptability of Prescribed Diurnal Exercise Timing
Targeting Diurnal Exercise Timing to Increase Exercise Levels Among Adults With Obesity: A Randomized, Crossover Pilot
調査の概要
状態
条件
詳細な説明
Performing at least 150 minutes of moderate intensity physical activity per week is associated with many health improvements. Some research suggests that people who exercise at the same time day-to-day perform more physical activity than those who exercise at variable times day-to-day, but it is not yet known if asking people to exercise at the same time day-to-day is helpful for becoming more active and whether there is a specific time of day (e.g., morning vs. evening) that is most helpful. Importantly, it is also not yet known whether people are able and willing to exercise at a specific time day-to-day. This study thus seeks to learn more about how feasible, acceptable, and helpful it is to exercise at an assigned time.
The study will last for 4 months total. Interested participants will be asked to attend an orientation visit at the research center to learn more about the study and will wear a physical activity monitor for 1 week to verify eligibility. Participants who enroll in the study will then complete a 45-minute session with study staff (in person or via videoconferencing) to learn strategies for safely increasing physical and will be asked to walk at a moderate intensity for at least 15 consecutive minutes every day during three, 3-week periods (9 weeks total). Each participant will be asked to perform this walking in the morning (5:00-10:00 AM) for one of the 3-week periods, in the evening (5:00-10:00 PM) for one of the 3-week periods, and at a time of their choice for one of the 3-week periods. Between each 3-week period with a daily exercise goal, there will be a 2-week break period with no exercise goal. Participants will be asked to wear a physical activity sensor on an elastic band around their waist during all waking hours for the full study duration to monitor their physical activity levels. They will also be emailed a survey about their physical activity each night during each of the 3-week exercise periods. Participants will receive a weekly email each week to provide support and encouragement for increasing their physical activity, and to report on how many days they wore the physical activity sensor. Lastly, participants will complete a visit at the research center at the end of the study to complete questionnaires about their experiences.
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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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Weight Control and Diabetes Research Center
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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:
- 35 to 65 years of age
- BMI between 30.0 and 50.0 kg/m2
- Able to read and write English
- Home access to the internet via computer or smart phone
- Ability to walk 10 consecutive min without assistance
- Currently performing <50 min/week of moderate intensity physical activity per week (verified via an accelerometer)
Exclusion Criteria:
- Current participation in another formal weight management or physical activity intervention
- Pregnant, <6 month postpartum, or planning to become pregnant in the next 3 months
- Presence of an uncontrolled mental health condition
- Extended absence (e.g., extended vacation) from the Providence area during the study
- Presence of a medical condition for which increased exercise may be contraindicated
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：クロスオーバー割り当て
- 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：Morning exercise
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
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Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 AM and 10 AM each day.
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実験的：Evening exercise
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
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Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 PM and 10 PM each day.
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アクティブコンパレータ：Time of choice exercise
Participants will have a daily exercise goal, receive nightly surveys, receive weekly emails, and wear a physical activity sensor daily.
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Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes at a time of their choice each day.
This time can change day-to-day.
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介入なし：No exercise period
During the two-week "washout" (i.e., break) periods between the exercise interventions, participants will not have an exercise goal.
Participants will continue to receive weekly emails and wear a physical activity sensor daily.
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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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Consent rates
時間枠：Pre-intervention
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Percent of eligible individuals electing to enroll in the study
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Pre-intervention
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Study completion rates
時間枠：At study completion, an average of 14 weeks
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Percent of consented individuals completing the post-intervention assessment
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At study completion, an average of 14 weeks
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Physical activity timing adherence rates
時間枠：Through study completion, an average of 14 weeks
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Percent of moderate intensity physical activity bouts per 3-week condition completed during the assigned time (i.e., 5-10 AM for the morning condition, 5-10 PM for the evening condition)
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Through study completion, an average of 14 weeks
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Acceptability questionnaire
時間枠：At study completion, an average of 14 weeks
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17-item questionnaire assessing satisfaction with and perceived helpfulness of prescribed physical activity timing overall and specifically in the morning and evening
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At study completion, an average of 14 weeks
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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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Average daily physical activity minutes
時間枠：Through study completion, an average of 14 weeks
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Average daily minutes of moderate-to-vigorous physical activity per week per each 3-week timing condition as measured by a hip-worn accelerometer
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Through study completion, an average of 14 weeks
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Average days per week with at least 15 min of physical activity
時間枠：Through study completion, an average of 14 weeks
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Average number of days per week with at least 15 minutes of moderate-to-vigorous physical activity per each 3-week timing condition as measured by a hip-worn accelerometer
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Through study completion, an average of 14 weeks
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Barriers and facilitators of physical activity questionnaire
時間枠：Through study completion, an average of 14 weeks
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Questionnaire administered nightly during each 3-week exercise period that assesses the presence and intensity of several barriers to (e.g., fatigue, scheduling conflicts) and facilitators of (e.g., habit, enjoyment) physical activity.
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Through study completion, an average of 14 weeks
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Preferred physical activity timing questionnaire
時間枠：At study completion, an average of 14 weeks
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Two self-report questions assessing preferred physical activity timing
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At study completion, an average of 14 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Leah Schumacher, PhD、The Miriam Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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。