Virtual Advisors for Physical Activity Promotion in Underserved Communities (COMPASS2)
調査の概要
詳細な説明
COMPASS (Computerized Physical Activity Support for Seniors) was a single-blind, cluster-randomized noninferiority parallel trial conducted by investigators from Stanford University School of Medicine and Northeastern University. Participants were recruited from community centers in Santa Clara and San Mateo Counties, CA which had been randomized in pairs based on locale to either Virtual or Human advisors. Allocation concealment was accomplished by utilizing staff not directly involved in study enrollment, assessment, or intervention procedures. Both arms received a similar 12-month behavioral PA instruction/support program at their designated community center based on Active Choices-an individually-tailored PA intervention with demonstrated effectiveness and translatability across diverse adult populations. The primary outcome was change in 12-month weekly walking minutes.
In addition to the major trial and primary investigation described above, an exploratory Substudy was conducted separately to begin to evaluate the initial "proof of concept" of a food literacy curriculum in 2 separate community centers that were not part of the major trial. This first-generation exploratory Substudy is not part of the major trial and therefore is not included in this protocol and trial description.
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
-
-
California
-
Palo Alto、California、アメリカ、94304
- Stanford Prevention Research Center
-
-
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:
- Spanish or English-speaking primarily Latino men or women
- Aged greater than or equal to 50 years
- No plans to move within the next year
- Inactive (have not engaged in moderate-intensity or more vigorous physical activity
- > 3 days per week for at least 20 min per day) within last 6 months
- Able to participate in study intervention and assessments at their local neighborhood senior center
Exclusion Criteria:
- Any medical condition or disorder that would limit participation in moderate intensity physical activity (such as sustained walking), including life-threatening disorders, myocardial ischemia, major functional disabilities in the orthopedic area, or inability to complete baseline assessments for any reason (including psychological, cognitive);
- Not stable on their medications, including hormone replacement therapy, for ≥ 3 months (given that changes in medications can create additional stress and burden over and above attempts to change lifestyle behaviors);
- Inability to complete a face-to-face training session with a computer-based program
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：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Promotora for physical activity
Weekly sessions with a volunteer promotora at a community center.
A promotora is a trained, lay health worker.
The promotora will provide guidance, advice and support to participants to encourage them to be more physically active.
|
A promotora is a trained, lay health worker.
Promotoras will be trained and supervised to provide advice, support and guidance to people to encourage them to be more physically active.
They work with people face to face and by telephone to offer support and advice.
|
|
実験的：Carmen system
Weekly sessions with the virtual advisor accessed through a computer located at a community center.
Carmen is the virtual advisor and will provide guidance, advice and support to participants to encourage them to be more physically active.
|
The virtual advisor is named Carmen.
She is an animated, computer-generated figure that speaks to participants and gives advice and support for physical activity.
|
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 |
|---|---|---|
|
Change in Total Weekly Walking Minutes From Baseline to 12 Months
時間枠：baseline, 12 months
|
Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)
|
baseline, 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Sedentary Behavior From Baseline to 12 Months
時間枠：baseline, 12 months
|
Self-reported time spent in the following activities: watching television, computer use, reading, socializing, transport and hobbies, and a summary measure (total sedentary time).
|
baseline, 12 months
|
|
Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months
時間枠：baseline, 12 months
|
moderate to vigorous intensity physical activity as measured by self-report questionnaire
|
baseline, 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Abby C King, PhD、Stanford University
出版物と役立つリンク
一般刊行物
- King AC, Campero MI, Sheats JL, Castro Sweet CM, Hauser ME, Garcia D, Chazaro A, Blanco G, Banda J, Ahn DK, Fernandez J, Bickmore T. Effects of Counseling by Peer Human Advisors vs Computers to Increase Walking in Underserved Populations: The COMPASS Randomized Clinical Trial. JAMA Intern Med. 2020 Nov 1;180(11):1481-1490. doi: 10.1001/jamainternmed.2020.4143.
- King AC, Campero I, Sheats JL, Castro Sweet CM, Garcia D, Chazaro A, Blanco G, Hauser M, Fierros F, Ahn DK, Diaz J, Done M, Fernandez J, Bickmore T. Testing the comparative effects of physical activity advice by humans vs. computers in underserved populations: The COMPASS trial design, methods, and baseline characteristics. Contemp Clin Trials. 2017 Oct;61:115-125. doi: 10.1016/j.cct.2017.07.020. Epub 2017 Jul 22.
研究記録日
主要日程の研究
研究開始 (実際)
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
- R01HL116448 (米国 NIH グラント/契約)
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。
Promotora for physical activityの臨床試験
-
University of OttawaThe Ottawa Hospital; Queen's University; Consortium of Multiple Sclerosis Centers完了
-
Centre Hospitalier Universitaire de Besancon募集