- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03509129
Columbia Moves Physical Activity
Evaluating Columbia Moves: A Social Network Approach Using a Team Competition and Technology to Increase Physical Activity
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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South Carolina
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Columbia, South Carolina, 미국, 29208
- University of South Carolina
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Insufficiently active as determined by a one-week, accelerometer-based physical activity measurement
- Body mass index (BMI) between 25 kg/m2 and 55 kg/m2
- Between ages 18 and 65 years
- Access to computer with Internet connection
- Smartphone ownership (Android or iOS)
- Willing to be randomized to either one of the two study groups
- Part of a self-selected team of 3-8 eligible individuals
- Members of the same household cannot be part of separate groups
- Able to walk at least 1/4 mile without stopping
Exclusion Criteria:
- Currently lactating, pregnant, or planning to become pregnant during the length of the study
- Diagnosed with type 1 or type 2 diabetes
- Medical or physical contraindications or limitations for engaging in physical activity
- History of major medical or psychiatric conditions
- Currently participating in a physical activity program
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: TECH (Technology)
Participants will receive a theory-based physical activity program.
They will enroll in the study as part of a self-selected group of 3-8 individuals.
They will be provided with a personal step goal and Fitbit Alta HR for self-monitoring physical activity.
They will also have access to a study website that will be accessible across conventional and mobile platforms.
They will be asked to visit the website each week to receive behavior change information and guidance.
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Participants will receive a theory-based physical activity program. They will enroll in the study as part of a self-selected group of 3-8 individuals. They will be provided with a personal step goal and Fitbit Alta HR for self-monitoring physical activity. They will also have access to a study website that will be accessible across conventional and mobile platforms. They will be asked to visit the website each week to receive behavior change information and guidance. Device: Fitbit Alta HR |
실험적: TECH+COMP (Technology + Competition)
Participants will receive the same intervention components as the TECH goup, as well as a study designed team competition.
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Participants will receive the same intervention components as the TECH group, as well as a team competition. The competition will be based on the following two aspects: total daily steps accumulated relative to group size and total number of points retained for achieving weekly physical activity challenges. Device: Fitbit Alta HR |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Accelerometer-measured change from Baseline Daily Steps at 3 months and 12 months
기간: 0, 3, and 12 months
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Change in daily steps
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0, 3, and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Accelerometer-measured change from Baseline Minutes of Moderate-to-Vigorous Physical Activity at 3 months and 12 months
기간: 0, 3, and 12 months
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Change in moderate-to-vigorous physical activity
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0, 3, and 12 months
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Change from Baseline in Perceived Social Support for Exercise (Sallis Social Support and Exercise Survey) at 3 and 12 months
기간: 0, 3, and 12 months
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Change in perceived social support for exercise (scale total score range: 1 to 5, with 1 representing low perceived social support for exercise and 5 representing high perceived social support for exercise; responses to all items are averaged to yield a total final score)
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0, 3, and 12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Participant Satisfaction (Satisfaction Questionnaire)
기간: 4 months
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Participant satisfaction with treatment
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4 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
- 2018
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .
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