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临床试验/NCT02574689
NCT02574689已完成不适用

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

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)

研究概览

简要总结

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.

详细描述

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
50 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

HIPP Intervention

Experimental

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.

干预措施: HIPP (Behavioral)

Wellness Contact Control

Active Comparator

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.

干预措施: Wellness contact control (Behavioral)

结局指标

主要结局

7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)

时间窗: baseline and 12 months

minutes/week of moderate intensity or greater physical activity

7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)

时间窗: baseline and 6 months

minutes/week of moderate intensity or greater physical activity

次要结局

  • body impedance analyses(baseline, 6 months, 12 months)
  • 6 minute walk test(baseline, 6 months, 12 months)
  • Decisional Balance scale(baseline, 6 months, 12 months)
  • Social Support for exercise scale(baseline, 6 months, 12 months)
  • waist circumference(baseline, 6 months, 12 months)
  • Physical Activity Enjoyment scale(baseline, 6 months, 12 months)
  • Self -Efficacy for physical activity scale(baseline, 6 months, 12 months)
  • body mass index(baseline, 6 months, 12 months)
  • accelerometers(baseline, 6 months, 12 months)
  • Stages of Readiness Measure(baseline, 6 months, 12 months)
  • processes of change measure(baseline, 6 months, 12 months)
  • Outcome expectations scale(baseline, 6 months, 12 months)

研究者

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

Dorothy Pekmezi, PhD

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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