- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03196570
Increasing Physical Activity in Latino Men
Increasing Physical Activity in Latino Men Through Tailoring
연구 개요
상세 설명
Physical Activity in Latino Men Through Tailoring is an individually randomized web and text message based pilot study, designed to increase physical activity amongst Latino men. The study is conducting formative research with a diverse population of Latino men to inform the adaptation of the Pasos Hacia La Salud web-based intervention, which was developed for Latina women, to an intervention focused on Latino men. Consideration will also be taken to ensure intervention material is culturally appropriate for Latino men of Caribbean, South and Central American origin. Half the study participants will be randomized into the intervention arm and half into the comparison group. Participants in the intervention arm will have access to a website where they can complete questionnaires, receive information, log their physical activity and set goals. Participants complete monthly questionnaires to establish their stage of change toward increasing their physical activity and receive information manuals based on their current stage of change. They will also have access to tip sheets via the study website and receive reoccurring text messages reminding them to log into the website. Participants in the comparison arm will have access to a similar website with information related to nutrition and overall wellness, not including physical activity.
The primary aims of this project are (1) to conduct formative research with a diverse population of RI Latino men to adapt the existing web-based interventions and add text message-based components to complement and enhance the intervention. The second primary aim is to determine the feasibility, acceptability, and preliminary efficacy of the intervention and the study recruitment, implementation and evaluation protocols with a diverse population of Latino men. An additional exploratory aim will be to examine potential moderators of treatment effects including demographics, acculturation, and environmental variables such as the neighborhood built, social and economic environments. The hypothesis is that participants randomized to the intervention condition will have greater increases in weekly minutes of physical activity after six months than those randomized to a wellness control condition. The results of this pilot study will inform a future randomized controlled trial with Latino men to increase PA.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Rhode Island
-
Providence, Rhode Island, 미국, 02912
- Brown University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Be sedentary ( participate in moderate intensity leisure time PA two days a week for less than 30 minutes a day, or less)
- Identify as a Latino male
- Speak Spanish
- Score of more than 16% on Spanish Shortened Test of Functional Health Literacy in Adults
- Own a cell phone with texting capabilities and have internet access
Exclusion Criteria:
- History of myocardial infarction or angina, insulin-dependent diabetes or hospitalization for diabetes in the past year, stroke, osteoarthritis, osteoporosis, orthopedic problems, or any medical condition that would make PA unsafe.
- Planning to move from the area in the next 6 months
- Hospitalization due to a psychiatric disorder in the past 3 years.
- BMI of 45 or higher and/or taking any medication that may impair PA tolerance or performance.
- If they or another family member is already enrolled in another PA or weight control study.
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 |
---|---|
실험적: Intervention
After randomization into the intervention arm, participants will be instructed on how to use the Spanish language study website.
During the six month intervention, they will complete online questionnaires to determine their stage of change towards increasing physical activity.
A manual of information will be automatically generated based on their responses.
Participants can read this information online, along with tip sheets related to increasing physical activity.
On the website they can also set weekly goals and log their weekly PA.
It will also include short videos with demonstrations for PA they can do at home and around their neighborhood.
Information will also include community resources (community centers, public events, parks) where they can be physically active.
Participants will also receive prompts and encouragement via text-message to encourage them to log into the website and continue to track their progress.
|
After randomization into the intervention arm, participants will be instructed on how to use the Spanish language study website.
During the six month intervention, they will complete online questionnaires to determine their stage of change towards increasing physical activity.
A manual of information will be automatically generated based on their responses.
Participants can read this information online, along with tip sheets related to increasing physical activity.
On the website they can also set weekly goals and log their weekly PA.
It will also include short videos with demonstrations for PA they can do at home and around their neighborhood.
Information will also include community resources (community centers, public events, parks) where they can be physically active.
Participants will also receive prompts and encouragement via text-message to encourage them to log into the website and continue to track their progress.
|
활성 비교기: Contact Control
Participants in the control arm will attend the same baseline orientation sessions and measurements as the intervention arm.
After randomization into the control group, participants will complete an introductory in-person session to introduce them to a website, similar in design, with information on health topics other than physical activity, including diet and other factors associated with CVD risk.
It will include information from NHLBI heart health materials for Latinos.
Topics include healthy eating, increasing fruit and vegetable consumption, reducing fat and salt intake, learning about cholesterol, stress management.
Participants will log onto a separate website unique to the control group and complete monthly surveys on the wellness topics and their progress.
Participants will also receive prompts and encouragement text-messages to encourage them to log onto the website.
|
Participants in the control arm will attend the same baseline orientation sessions and measurements as the intervention arm.
After randomization into the control group, participants will complete an introductory in-person session to introduce them to a website, similar in design, with information on health topics other than physical activity, including diet and other factors associated with CVD risk.
It will include information from NHLBI heart health materials for Latinos.
Topics include healthy eating, increasing fruit and vegetable consumption, reducing fat and salt intake, learning about cholesterol, stress management.
Participants will log onto a separate website unique to the control group and complete monthly surveys on the wellness topics and their progress.
Participants will also receive prompts and encouragement text-messages to encourage them to log onto the website.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Physical Activity from Baseline to 6 months
기간: Baseline and 6 months
|
Minutes of Moderate and Vigorous Physical Activity
|
Baseline and 6 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
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
- 1612001664
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. .
신체 활동에 대한 임상 시험
-
University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스
Physical Activity Intervention에 대한 임상 시험
-
Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)완전한
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Splendor-NC모병비만 | 초과 중량 | 체중 | 체중 감량 | 체중 변화 | 만성 질환 | 과체중 및 비만 | 신체 활동 부족 | 행동, 식사 | 중량 감소미국
-
VA Office of Research and Development모집하지 않고 적극적으로