- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03399916
Ecological Momentary Determinants of Sedentary Behavior
TranSITion: Ecological Momentary Determinants of Sedentary Behavior
연구 개요
상세 설명
Phase 1: This is an observational study that will utilized Ecological Momentary Assessment, to determine which personal (e.g. fatigue, mood, and stress level), behavioral (e.g. watching TV, working at desk, and eating meals), environmental (e.g. being at home or work, time of the day, and weather) and contextual factors were associated with sedentary behavior. Three EMAs per day will be sent randomly sent to participants on weekdays (Monday to Friday), for four consecutive weeks (total of 20 days). During these days, participants will also wear an activPAL device to objectively measure sedentary behavior. The purpose of the study is to identify the combination of factors most likely to precede and proceed short (<30 min) and long (≥30 min) bouts of sedentary behavior.
Phase 2: A micro-randomized trial will be used to evaluate the efficacy of an email-based prompt to elicit a proximal effect (e.g., a postural response defined as a transition from seated to standing or seated to moving within 5 minutes to interrupt prolonged sitting) compared to a no prompt condition. A secondary aim of this study is to determine whether prompts that encourage standing are more likely to elicit a response than those that encourage moving. An exploratory aim is to examine whether varying the content of the stand or move prompt to include combinations of short term goals and employer approval, influence the magnitude of response.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85004
- Arizona State University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Full-time employees
- Males or females
- Ages 18-65
- Sedentary working habits (as indicated by >7 hrs/day of sedentary time at work in the Sedentary Behavior Questionnaire)
- Willing to engage in the study assessment and intervention for 10 weeks.
Exclusion Criteria:
- Non-ambulatory, pregnant
- Non-English speaking
- Diagnosis of psychiatric problems or taking psychiatric medications
- Medical history that prohibits prolonged standing.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Prompt
An email based prompt was sent- containing either a stand or move message.
Exploratory variations of the prompt were designed to include the addition of a goal e.g., stand for the next 5-minutes, and/or employer support e.g., PTS says "stand for the next 5 minutes".
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간섭 없음: No Prompt
Prompt delivery was sequentially randomized to be sent (ST) or not sent (NST) to all participants (probability of 0.5), at eight decision points per day (between 9am and 5pm), to achieve a total of 3200 randomizations across participants (160 per participant).
Therefore 50% of the time, no prompt was sent.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Minutes of sitting behavior (minutes/8h workday)
기간: 40 days
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Objectively measured minutes of sitting, standardized to an 8h workday.
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40 days
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Minutes of standing behavior (minutes/8h workday)
기간: 40 days
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Objectively measured minutes of standing, standardized to an 8h workday.
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40 days
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Minutes of light-intensity physical activity (minutes/8h workday)
기간: 40 days
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Objectively measured minutes of light-intensity physical activity, standardized to an 8h workday.
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40 days
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Minutes of moderate-vigorous physical activity (minutes/8h workday)
기간: 40 days
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Objectively measured minutes of moderate-vigorous physical activity, standardized to an 8h workday.
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40 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Momentary affective state (4-item Likert Scales)
기간: 20 days
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Affective states will be assessed using an ecological momentary survey based on the Positive and Negative Affect Scale (4-point Likert scale ranging from "not at all" to "extremely") (Range: 1-4) questionnaire.
The ecological momentary assessment questions were designed to assess a range of contextual information (i.e., current office location, posture, social interaction) and physical and emotional feeling states (i.e., calmness, energy, happiness, stress, sadness, pain level, productivity, and willingness to stand/move).
Each of these questions will be evaluated individually andaveraged to evaluate positive (i.e., calmness, energy, happiness) and negative (i.e., sadness and stress) affective states.
An open-source app (Personal Analytic Companion App) will be used to deliver EMA questions randomly throughout a participant's workday.
This will allow us to measure self-reported levels of positive or negative affect.
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20 days
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공동 작업자 및 조사자
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 (실제)
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
- STUDY00004349
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
좌식 행동에 대한 임상 시험
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University of Haifa완전한산후 기간 | 산모 정신 건강 | Parenting / Maternal Behavior | 초산 (첫 아이를 임신한 산모) | 산후 우울 증상이스라엘
Prompt sent에 대한 임상 시험
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University of Colorado, DenverPatient-Centered Outcomes Research Institute; Northwestern University; Yale University; University... 그리고 다른 협력자들모병