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临床试验/NCT02627235
NCT02627235已完成不适用

The Deep South IVR-based Active Lifestyle (DIAL) Study

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Consumer Satisfaction Survey

研究概览

简要总结

This pilot study represents an initial foray into delivering an Individual Voice Response-based (IVR) physical activity intervention for cancer risk among sedentary adults in the Deep South.

详细描述

60 participants will receive the DIAL intervention or Wait List Control. While main outcomes are focused on feasibility and acceptability, physical activity, fitness, and body weight and composition data will be collected and measured at baselines and 12-weeks.

DIAL Intervention: The physical activity intervention is based on Social Cognitive Theory and emphasizes behavioral strategies for increasing activity levels (i.e., goal setting, self-monitoring, problem solving barriers, increasing social support, rewarding oneself for meeting physical activity goals) and includes daily activity reporting via an Individual Voice Response (IVR) system that allows computer-assisted interaction with participants by telephone. Computer expert system feedback on physical activity progress will be based on participants' reported daily step counts and >moderate intensity PA . In addition to IVR system feedback, participants will receive monthly graphic-based feedback letters delivered by mail. Messages will encourage incremental increases until national PA guidelines are reached and provide specific information on cancer risk reduction ("In the past 7 days, you called the DIAL study line all 7 days and reported engaging in 80 minutes of moderate intensity PA. The national guidelines call for >150 min/week of moderate intensity PA so you are well on your way. Keep up the good work. Make small increases in PA each week until you reach that goal. Remember: 30-60 min/day of moderate-vigorous intensity PA may significantly lower your risk of breast and colon cancer").

To improve self-efficacy, social support, outcome expectations, and perceived enjoyment, we will assess these variables at baseline, 30, 60, and 90 days. Responses will be used to select appropriate tailored feedback modules (for low self-efficacy score, "You do not seem confident about your ability to exercise. Often trying to fit in some PA on top of the demands of work and family can be a challenge. Try making time for a 10 minute walk 1-2 days this week. It will help build confidence about your ability to fit PA into your lifestyle.") Finally, participants will receive access to problem solving modules, addressing PA barriers identified by the community during formative research (lack of time, negative outcome expectations, enjoyment, social support, see table below). Module options will be rotated and constantly updated to keep participants engaged.

Wait List Control Condition: Will receive the intervention after 12 weeks following baseline assessments.

研究设计

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

入排标准

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

入选标准

  • 21 years or older
  • Underactive (<60 min/week moderate PA)
  • Able to speak/read English
  • Willing to be assigned to either condition
  • Access to a telephone
  • Not planning to move from the area in the next 4 months
  • Healthy (BMI 18.5-45; No history of heart disease, myocardial infarction, angina, stroke, or orthopedic conditions which limit mobility, or any serious medical condition that would make physical activity unsafe; no psychiatric hospitalization in past 3 years).

排除标准

  • 未提供

结局指标

主要结局

Consumer Satisfaction Survey

时间窗: 3 months

Satisfaction with IVR-based system intervention

次要结局

  • Physical Activity Enjoyment scale(Baseline, 1 month, 2 months, and 3 months)
  • Outcome expectations scale(Baseline, 1 month, 2 months, and 3 months)
  • Accelerometers(Baseline and 3 months)
  • Self -Efficacy for Exercise Measure(Baseline, 1 month, 2 months, and 3 months)
  • 7 Day Physical Activity Recall(Baseline and 3 months)
  • 6 Minute Walk Test(Baseline and 3 months)
  • body mass index(Baseline and 3 months)
  • body impedance analyses(Baseline and 3 months)
  • Social Support for exercise scale(Baseline, 1 month, 2 months, and 3 months)
  • waist circumference(Baseline and 3 months)

研究者

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

Dorothy Pekmezi, PhD

Associate Professor

University of Alabama at Birmingham

研究点 (2)

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