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临床试验/NCT05997888
NCT05997888已完成不适用

Examining the Feasibility, Acceptability, and Preliminary Efficacy of a Six-week At-home Strength Training Intervention for Black Women

University of Minnesota2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Acceptability

研究概览

简要总结

The current study will be a randomized controlled pilot study conducted in the Midwest. Participants will be randomly assigned to a behavioral intervention or a wait-list control group, each lasting six weeks. The intervention group will first have an in-person meeting at the beginning of the intervention to discuss the study, go over movements, and discuss Zoom and WhatsApp instructions. The behavioral intervention will consist of three home-based workouts per week sent digitally and Zoom session per week that will have an exercise session and a group counseling session. Additionally, each week participants will be sent a motivational prompt via WhatsApp and will be encouraged to connect with each other about physical activity motivation, barriers, and facilitators. Acceptability, physical activity and psychosocial variables of interest will be measured via accelerometer data (via Actigraph GT3X) and self-report at baseline and six weeks (post-intervention). Focus groups will be conducted for all participants at the conclusion of the study to further assess acceptability, feasibility, and efficacy of the program.

详细描述

Step 1- Formative Focus Groups: Prior to recruitment of participants, three focus groups with five to eight members of the target population per group will be conducted to accomplish the following: 1) Review intervention materials such as exercise session content, motivational construct activities, and counseling session topics, and 2) assess any barriers and facilitators within their environments that should be accounted for in the methodology of the study, and 3) to explore how racism impacts their lives and how their ability to engage in physical activity. A trained consultant will ask questions regarding length of workouts, frequency of messaging on WhatsApp, whether video calls between participants and the PI would be helpful, and what type of messaging and video content the participants may like to see, in accordance with similar literature in the field (Joseph et al., 2017). Formative research participants will be paid $20 for their time. After the focus groups conclude, the PI and another researcher will conduct inductive hierarchical content analysis to incorporate results into the intervention structure and design. Audio and/or video recordings will be taken in order to accurately analyze themes and adjust the protocol based on answers from the focus groups. The protocol of the intervention will be adjusted with results from the formative focus groups after receiving relevant input.

Step 2- Telephone Screening, Consent, and Baseline Questionnaires: In response to advertisement and outreach efforts, potential participants will call, email, or text the Student Investigator (SI), at which time they will complete a telephone screening interview with the SI to determine eligibility for the study. Participants who are eligible will be given detailed information about the study and the consent form will be reviewed. The SI will schedule a randomization appointment in two weeks. Participants will be told that they may need to cancel the appointment if the online consent and questionnaires are not completed.

a) Complete telephone screening

  1. If not eligible, end interview and thank them for their time
  2. If eligible:

i. Schedule randomization appointment for 2 weeks ii. Email link to consent form and questionnaires iii. Explain ActiGraph procedures. The Actigraph is a small device that is attached to the participant's clothing/belt at the waist and measures physical activity amount and intensity. The Actigraph functions as a method of measuring physical activity with the purpose of obtaining objective measurement of the participants' physical activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Identify as Black
  • Be categorized as insufficiently active, defined as less than 90 minutes of physical activity and less than two days of strength training
  • Live in the Twin Cities area
  • Be at least 18 years-old
  • Be able to participate in the study for six weeks and agree to participate in a focus group at the conclusion of the study
  • Possess a smartphone
  • Be willing to wear an accelerometer (Actigraph GT3X) for the duration of the study
  • Be able to attend a weekly 60 minute Zoom session on one of two selected nights
  • Be willing to be randomized to the intervention or control condition.

排除标准

  • Do not identify as Black
  • Are active over 90 minutes per week
  • Are under 18 years-old
  • Will be unable to participate in the full study
  • Do not possess a smartphone
  • Are unwilling to wear an accelerometer
  • Are unwilling to be randomized to either condition
  • Are pregnant
  • Have a serious physical or mental condition that would interfere with the ability to do physical activity
  • Are currently enrolled in another exercise-related study.

结局指标

主要结局

Acceptability

时间窗: Six weeks

Acceptability will also be assessed with a customer satisfaction form, which asks participants to respond on a seven-point Likert scale, with one = "very dissatisfied" to seven = "very satisfied". Participants will be asked to rate their satisfaction on a variety of elements such as Zoom sessions, weekly WhatsApp messages, and the overall program.

Feasibility of the programs

时间窗: Six weeks

Customer satisfaction. Feasibility of the intervention will be measured by looking at acceptability and implementation of the intervention. Level of acceptability will be assessed by examining the percentage of Zoom sessions (both group and individual) attended and self-reported number of exercise sessions completed per week. This measure will be assessed on a 1-7 point Likert scale, with one = "very dissatisfied" to seven = "very satisfied". Participants will be asked to rate their satisfaction on a variety of elements such as Zoom sessions, weekly WhatsApp messages, and the overall program.

次要结局

  • Enjoyment(six weeks)
  • outcome expectations(six weeks)
  • Behavioral regulation(six weeks)
  • self-efficacy(six weeks)
  • Social support(six weeks)
  • Physical Activity(six weeks)

研究者

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

Beth Lewis

Principal Investigator

University of Minnesota

研究点 (2)

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