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임상시험 NCT06337708은(는) 신체 활동, 운동, 심장 질환, 당뇨병, 신체 비활동에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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애리조나 주립 대학교Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '시험 설명하기'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06337708은(는) 예방을(를) 알아보기 위한 연구입니다. 이 연구는 신체 활동, 운동, 심장 질환, 당뇨병, 신체 비활동에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 4월 8일에 시작되어 240명의 참여자를 모집하고 있습니다. 애리조나 주립 대학교이(가) 진행하며, 2028년 3월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 5월 16일에 갱신되었습니다.
간단한 개요
The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women.
상세한 설명
This study addresses major public health concerns among African American women: physical inactivity and cardiometabolic disease risk.
African American women experience a high burden of cardiometabolic diseases, including heart disease, obesity, and type 2 diabetes. Regular aerobic physical activity is an established behavior to prevent and treat these conditions. Yet, the many African American women are insufficiently active, with only 27-40% meeting national aerobic physical activity guidelines.
This study will test the efficacy of Smart Walk, a culturally tailored, theory-based smartphone-delivered intervention designed to increase physical activity and improve cardiometabolic disease risk factors among African American women. In a 12-month trial, participants will be randomly assigned to either the Smart Walk intervention or a Fitbit-only comparison arm for an active 4-month intervention period, followed by an 8-month minimal contact follow-up period.
Specific Aims:
- Test the effects of Smart Walk to increase physical activity and promote adherence to national aerobic physical activity guidelines; compared to Fitbit-only comparison group.
- Test the effects of Smart Walk to improve cardiometabolic risk factors; compared to Fitbit-only comparison group.
- Compare cost and cost effectiveness of the two intervention groups from a societal perspective.
- Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes.
공식 제목
Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
질환/상태
신체 활동운동심장 질환당뇨병신체 비활동기타 연구 식별자
- STUDY00017286
- R01HL168170 (NIH (미국 국립보건원) 보조금/계약)
NCT 번호
실제 연구 시작일
2024-04-08
최신 업데이트 게시
2025-05-16
예상 연구 완료일
2028-03-31
계획된 등록 인원
240
연구종류
중재연구
단계/상
2상
상태
모집중
키워드
mHealth
women's health
health equity
African American women
Black women
exercise
physical activity
heart disease
diabetes
women's health
health equity
African American women
Black women
exercise
physical activity
heart disease
diabetes
주요 목적
예방
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Smart Walk Participants will receive a culturally tailored smartphone-delivered physical activity intervention. | Smart Walk Smart Walk is a culturally tailored, Social Cognitive Theory-based multi-component smartphone delivered physical activity (PA) promotion intervention that delivered through the Smart Walk application, virtual physical activity coaching, and text messages. The Smart Walk smartphone application includes four key features: 1) personal profile pages, 2) culturally relevant multi-media physical activity promotion modules, 3) discussion boards, and 4) physical activity self-monitoring/tracking feature that integrates with Fitbit activity monitors for participants to track their daily, weekly, and monthly activity. Virtual physical activity coaches will actively engage and facilitate group-based dialogue among participants on the app discussion boards and provide individualized, one-on-one PA coaching via telephone or commercially available app-based video teleconferencing software (i.e., FaceTime, Zoom, Google hangouts). |
활성 대조군Fitbit Participants will receive a Fitbit Inspire 3 activity monitor. | 핏빗 This intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months | Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity | Assessed at baseline, 4-months, 12-months |
Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months | Assessed by the 7-Day Physical Activity Recall | Assessed at baseline, 4-months, 12-months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change in cardiorespiratory fitness from baseline to 4- and 12-months | A modified Balke treadmill protocol will be used to estimate maximal aerobic capacity (i.e., VO2 peak). | Assessed at baseline, 4-months, 12-months |
Change in aortic pulse wave velocity from baseline to 4- and 12-months | A measure of aortic stiffness and will be assessed using SphygmoCor XCEL system using validated methodology. | Assessed at baseline, 4-months, 12-months |
Change in body weight from baseline to 4- and 12-months. | Measured in kilograms using an electronic scale | Assessed at baseline, 4-months, 12-months |
Change in body mass index from baseline to 4- and 12-months | Calculated using the formula: weight (in kilograms) / height (in meters)squared | Assessed at baseline, 4-months, 12-months |
Change in waste circumference from baseline to 4- and 12-months | Measured in centimeters | Assessed at baseline, 4-months, 12-months |
Change in blood pressure (mmHG) from baseline to 4- and 12-months | Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest | Assessed at baseline, 4-months, 12-months |
Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months | Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast. | Assessed at baseline, 4-months, 12-months |
Change in interleukin 6 (IL-6) from baseline to 4- and 12-months | Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast. | Assessed at baseline, 4-months, 12-months |
Change in interleukin 10 (IL-10) from baseline to 4- and 12-months | Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast. | Assessed at baseline, 4-months, 12-months |
Change in interleukin 15 (IL-15) from baseline to 4- and 12-months | Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast. | Assessed at baseline, 4-months, 12-months |
Change in fasting blood glucose glucose from baseline to 4- and 12-months | Plasma glucose assessed after a 10 hour fasting blood draw. Measured using an automated chemistry analyzer. | Assessed at baseline, 4-months, 12-months |
Change in serum insulin from baseline to 4- and 12-months | Serum insulin collected after a 10 hour fasting blood draw. | Assessed at baseline, 4-months, 12-months |
Change in serum lipids (mg/DL) from baseline to 4- and 12-months | Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed | Assessed at baseline, 4-months, 12-months |
Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months | Assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (μU/ml)/405. | Assessed at baseline, 4-months, 12-months |
Change in exercise self-efficacy from baseline to 4- and 12-months | Assessed by the 12-item Exercise Self-Efficacy survey (Sallis et al.1987). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-efficacy. | Assessed at baseline, 4-months, 12-months |
Change in self-regulation for physical activity from baseline to 4- and 12-months | Assessed by the 10- item Self-Regulation Scale from the Health Beliefs Survey (Anderson-Bill 2006). This scale assesses the use of behavioral strategies to incorporate physical activity into daily activities (i.e., take stairs instead of elevator, walking instead of driving when running errands). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-regulation. | Assessed at baseline, 4-months, 12-months |
Change in social support for physical activity from baseline to 4- and 12-months | Assessed by the Social Support for Exercise survey developed by Sallis et al (1987). This scale assesses social support from family support (10-items, with a possible range of scores from 10-50) and friends (8-items, with a possible score range from from 8-40). Higher scores indicate greater levels of social support. | Assessed at baseline, 4-months, 12-months |
Change in outcome expectations for physical activity from baseline to 4- and 12-months | Assessed using the 9-item Outcome Expectation Scale for Exercise scale, developed by Resnick (2000). The range of possible scores for this measure is 1-5, with higher scores indicating more positive expectancies associated with physical activity engagement. | Assessed at baseline, 4-months, 12-months |
Change in behavioral capability for physical activity from baseline to 4- and 12-months | Assessed using a 6-item scale developed by the research team in previous research. The range of possible scores for this measure is 1-6, with higher scores indicating higher levels of behavioral capability of physical activity. | Assessed at baseline, 4-months, 12-months |
적격성 기준
연령대
성인, 노인
최소 연령
24 Years
참여 가능한 성별
여성
건강한 참가자 허용
네
- Self-reported African American/Black female
- Aged of 24-65 years
- Insufficiently Active (< 60 minutes of moderate-to-vigorous physical activity per week as measured by Exercise Vital Sign Questionnaire)
- BMI > 30 kg/m2
- English speaking and reading
- Ownership of a smartphone with the ability to download applications (i.e., apps)
- Ownership of a smartphone with the ability to receive text messages
- Willingness to receive a physical activity intervention delivered through their smartphone
- Willingness to include their first name or create an alias to be used on their profile page on the Smart Walk app
- Plans to relocate out of Phoenix area in next 12 months
- Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a doctor's note for study participation in provided
- Resting systolic blood pressure greater than 180 mmHG and/or a diastolic blood pressure greater than 120 mmHG , as assessed at baseline or at any other study assessment
- Self-reported participation in another diet or weight loss study at screening
- Pregnant or planning to become pregnant in the next 12 months
애리조나 주립 대학교83개의 진행 중인 임상시험 탐색 가능미국 국립심장폐혈액연구소758개의 진행 중인 임상시험 탐색 가능연구 대표 연락처
연락처: Rodney P Joseph, PhD, 602-496-0772, [email protected]
1 1개국에 임상시험 장소
Arizona
Arizona State University, Phoenix, Arizona, 85004, United States
Carina Platte, PhD, 연락처, 602-543-2213, [email protected]
Rodney Joseph, PhD, 책임연구자
모집중