University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: NCT02574689
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.
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Notify Me50 year–69 year
Female
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
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.
Time frame: baseline and 6 months
minutes/week of moderate intensity or greater physical activity
Time frame: baseline and 12 months
minutes/week of moderate intensity or greater physical activity
Time frame: baseline, 6 months, 12 months
meters walked in 6 minutes
Time frame: baseline, 6 months, 12 months
kg/m^2
Time frame: baseline, 6 months, 12 months
cm
Time frame: baseline, 6 months, 12 months
% body fat
Time frame: baseline, 6 months, 12 months
range=0-65 for both friends and family subscales, with higher scores indicating more social support
Time frame: baseline, 6 months, 12 months
range= 1-5, with higher scores representing more outcome expectations
Time frame: baseline, 6 months, 12 months
range=18-126, with higher scores indicating more enjoyment
Time frame: baseline, 6 months, 12 months
minutes/week of moderate intensity or greater physical activity
Time frame: baseline, 6 months, 12 months
categorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)
Time frame: baseline, 6 months, 12 months
range= 1-5, with higher scores representing more self-efficacy
Time frame: baseline, 6 months, 12 months
range= 1-5, with higher scores representing greater use of cognitive and/or behavioral processes of change
Time frame: baseline, 6 months, 12 months
scores >0 indicate more advantages than disadvantages to physical activity
University of Alabama at Birmingham
Other
Acronym: HIPP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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