Virtual Advisors for Physical Activity Promotion in Underserved Communities (COMPASS2)
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Palo Alto, California, 미국, 94304
- Stanford Prevention Research Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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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.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Total Weekly Walking Minutes From Baseline to 12 Months
기간: baseline, 12 months
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Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)
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baseline, 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Sedentary Behavior From Baseline to 12 Months
기간: baseline, 12 months
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Self-reported time spent in the following activities: watching television, computer use, reading, socializing, transport and hobbies, and a summary measure (total sedentary time).
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baseline, 12 months
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Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months
기간: baseline, 12 months
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moderate to vigorous intensity physical activity as measured by self-report questionnaire
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baseline, 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Abby C King, PhD, Stanford University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- R01HL116448 (미국 NIH 보조금/계약)
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