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临床试验/NCT05519696
NCT05519696招募中不适用

The Together Everyone Achieves More Physical Activity Trial

University of South Carolina2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2022年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
2
主要终点
Total Physical Activity

研究概览

简要总结

The Together Everyone Achieve More (TEAM) Physical Activity trial evaluates the efficacy of a group-based social affiliation intervention (vs. a standard group-delivered physical activity comparison program) for increasing physical activity among inactive African American women. Using a group cohort randomized design implemented at community centers across five years, the primary aim of this study is to evaluate the efficacy of the 10-week TEAM-PA group-based intervention (vs. comparison program) on increasing daily total physical activity from baseline to post-intervention and maintenance at a 6-month follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

All measurement staff will be blind to treatment condition

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • at least 18 years of age
  • self-identifying as an African American or Black female
  • engaging in < 60 minutes of moderate to vigorous physical activity per week for the last three months

排除标准

  • having a cardiovascular or orthopedic condition that would limit physical activity (including walking with a cane/walker)
  • currently pregnant or planning to become pregnant in the next 2 months
  • uncontrolled blood pressure (systolic >180 mmHg/diastolic > 110 mmHg)

结局指标

主要结局

Total Physical Activity

时间窗: Baseline, post-intervention (10 weeks), and 6 months post-intervention

Average minutes of total physical activity (PA) per day; Objective assessments of total PA will be obtained with ActiGraph accelerometers. Participants will wear the monitor on the non-dominant wrist for 7 consecutive days. The investigators will evaluate whether there is a change in minutes of total PA per day from baseline to 10 weeks and maintenance at 6 months post-intervention, and whether there are group differences between the intervention and comparison programs.

次要结局

  • Percentage meeting national guidelines for weekly moderate to vigorous physical activity(Baseline, post-intervention (10 weeks), and 6 months post-intervention)
  • Light Physical Activity(Baseline, post-intervention (10 weeks), and 6 months post-intervention)
  • Sedentary Behavior(Baseline, post-intervention (10 weeks), and 6 months post-intervention)
  • Body Mass Index (BMI)(Baseline, post-intervention (10 weeks), and 6 months post-intervention)
  • Blood Pressure(Baseline, post-intervention (10 weeks), and 6 months post-intervention)
  • Two-Minute Walk Test (Walking Speed)(Baseline, post-intervention (10 weeks), and 6 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allison M. Sweeney

Assistant Professor

University of South Carolina

研究点 (2)

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