Investigating Sedentary Time in Aging: New Directions (ISTAND)
調査の概要
詳細な説明
To date, no one has tested whether the prompting features of commercially available wrist-worn devices (e.g., Jawbone Up) improve breaks from sitting. Single case designs are a cost-effective way to conduct a controlled, randomized study that can inform larger intervention trials. Because the investigators are interested in ascertaining the effect of a very specific intervention on a very specific/single outcome, this study is well-suited to this approach.
The investigators will conduct iterative single case experimental studies using randomization tests. This design can help evaluate technologies for behavior change. To increase statistical power, the investigators opted to conduct an ABA study design (also termed a reversal design) where A is baseline and B is an intervention. Using randomization tests, the length of each A and B phase are determined to vary randomly in length prior to the beginning of each participant's experiment. The investigators will constrain the total time of each A and B phase to last a minimum of 5 days to provide adequate exposure to the A (measurement only) and B (intervention) conditions. The maximum total number of days participants will be enrolled is 28.
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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Washington
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Seattle、Washington、アメリカ、98101
- Group Health Research Institute
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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:
- Male or female
- BMI of 25+
- Ages 60+
- Continuously enrolled at Group Health for previous 12 months
- No record of death
- Not on the No Contact list
- Speaks, reads, and writes English
- Able to hold a conversation by phone (no hearing or other limitations)
- Self-reported ability to stand
- Self-reported ability to walk one block unassisted
- No history of an injury from a fall in past 3 months
- Work or retirement situations allows for taking breaks from sitting throughout the day
- Available for the study duration
- No unusual activities planned (e.g. travel, moving) during the study period
- Able to come to Group Health Capitol Hill/Central for measurement visits
- Willing to wear activity monitor (activPAL)
- Self-reports taking less than 4 breaks from sitting during an average hour
- Self-reports sitting more than 7 hours per day
Exclusion Criteria:
- Resides in long-term care, hospice care, or skilled nursing facility (previous 12 months)
- Wheelchair bound
- Diagnosis of dementia, serious mental health disorder, or substance use disorder (previous 24 months)
- Use of an assistive device
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：支持療法
- 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 |
|---|---|
|
実験的：Sitting time prompt
All participants will receive a prompting device (one-arm intervention).
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Participants will receive a device that prompts them to take breaks from sitting approximately every 15-20 minutes.
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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 |
|---|---|---|
|
Sit-to-stand transitions
時間枠：up to 28 days
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Number of activPAL-measured sit-to-stand transitions measured at the day level
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up to 28 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Dori E Rosenberg, PhD, MPH、Group Health Research Institute
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 (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
本研究に関する用語
キーワード
その他の研究ID番号
- 5 K23 HL119352-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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。