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Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South (HIPP)

2020年4月17日 更新者:Dorothy Pekmezi, PhD、University of Alabama at Birmingham
This pilot study represents an initial foray into delivering home-based individually-tailored physical activity interventions for cancer risk reduction among African American women in the Deep South.

研究概览

详细说明

80 women will receive the HIPP Intervention or Wellness Contact Control. While main outcomes are focused on feasibility and acceptability, physical activity, fitness, and body weight and composition data will be collected at baseline, 6 months, and 12 months, along with blood draws.

HIPP Intervention: The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model 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 regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports. Computer expert system feedback reports will be based on participants' monthly update survey data and include information on:

  1. current stage of motivational readiness for physical activity;
  2. increasing self- efficacy (i.e., confidence) for physical activity participation;
  3. weighing the pros and cons of engaging in physical activity (decisional balance);
  4. social support from family and friends for physical activity participation;
  5. outcome expectations (beliefs regarding the consequences of physical activity participation);
  6. perceived enjoyment of physical activity;
  7. how the participant compares to her prior responses (progress feedback);
  8. how the participant compares to individuals who are physically active and with national guidelines (normative feedback);
  9. self monitoring of physical activity behavior (using pedometers and activity logs to track the total steps and minutes of moderate intensity physical activity per day).

The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity. Intervention participants will also receive tip sheets addressing physical activity barriers specific to African American women in the Deep South (as identified during our focus groups and comprehensive literature review).

Wellness Contact Control Condition: Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society (ACS) website (www.cancer.org) will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.

研究类型

介入性

注册 (实际的)

83

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alabama
      • Birmingham、Alabama、美国、35233
        • University of Alabama at Birmingham

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 69年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • African American
  • Post-menopausal (defined as not having menstrual periods for at least 12 months)
  • Not taking hormone replacement therapy
  • Healthy (BMI 18.5-40; 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).
  • Not taking medication that may impair physical activity tolerance or performance (e.g., beta blockers).
  • Not planning to move from the area for the next 12 months
  • Willing to be randomized to either study arm and adhere to study protocol

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:HIPP Intervention
The physical activity intervention 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 regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports.
The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and includes motivation-matched physical activity manuals and individually-tailored computer expert system feedback reports. Tailored reports are based on participants' monthly update survey data and cover: 1) current stage of change; 2) self-efficacy; 3) decisional balance; 4) social support; 5) outcome expectations; 6) enjoyment; 7) progress feedback; 8) normative feedback; 9) self regulation. The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity.
有源比较器:Wellness Contact Control
Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the ACS website (www.cancer.org) will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society website (www.cancer.org) are mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
大体时间:baseline and 6 months
minutes/week of moderate intensity or greater physical activity
baseline and 6 months
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
大体时间:baseline and 12 months
minutes/week of moderate intensity or greater physical activity
baseline and 12 months

次要结果测量

结果测量
措施说明
大体时间
6 minute walk test
大体时间:baseline, 6 months, 12 months
meters walked in 6 minutes
baseline, 6 months, 12 months
body mass index
大体时间:baseline, 6 months, 12 months
kg/m^2
baseline, 6 months, 12 months
waist circumference
大体时间:baseline, 6 months, 12 months
cm
baseline, 6 months, 12 months
body impedance analyses
大体时间:baseline, 6 months, 12 months
% body fat
baseline, 6 months, 12 months
Social Support for exercise scale
大体时间:baseline, 6 months, 12 months
range=0-65 for both friends and family subscales, with higher scores indicating more social support
baseline, 6 months, 12 months
Outcome expectations scale
大体时间:baseline, 6 months, 12 months
range= 1-5, with higher scores representing more outcome expectations
baseline, 6 months, 12 months
Physical Activity Enjoyment scale
大体时间:baseline, 6 months, 12 months
range=18-126, with higher scores indicating more enjoyment
baseline, 6 months, 12 months
accelerometers
大体时间:baseline, 6 months, 12 months
minutes/week of moderate intensity or greater physical activity
baseline, 6 months, 12 months
Stages of Readiness Measure
大体时间:baseline, 6 months, 12 months
categorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)
baseline, 6 months, 12 months
Self -Efficacy for physical activity scale
大体时间:baseline, 6 months, 12 months
range= 1-5, with higher scores representing more self-efficacy
baseline, 6 months, 12 months
processes of change measure
大体时间:baseline, 6 months, 12 months
range= 1-5, with higher scores representing greater use of cognitive and/or behavioral processes of change
baseline, 6 months, 12 months
Decisional Balance scale
大体时间:baseline, 6 months, 12 months
scores >0 indicate more advantages than disadvantages to physical activity
baseline, 6 months, 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dori Pekmezi, PhD、University of Alabama at Birmingham

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年9月1日

初级完成 (实际的)

2019年12月1日

研究完成 (实际的)

2019年12月1日

研究注册日期

首次提交

2015年9月15日

首先提交符合 QC 标准的

2015年10月13日

首次发布 (估计)

2015年10月14日

研究记录更新

最后更新发布 (实际的)

2020年4月21日

上次提交的符合 QC 标准的更新

2020年4月17日

最后验证

2020年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • X130405004

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