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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: current stage of motivational readiness for physical activity; increasing self- efficacy (i.e., confidence) for physical activity participation; weighing the pros and cons of engaging in physical activity (decisional balance); social support from family and friends for physical activity participation; outcome expectations (beliefs regarding the consequences of physical activity participation); perceived enjoyment of physical activity; how the participant compares to her prior responses (progress feedback); how the participant compares to individuals who are physically active and with national guidelines (normative feedback); 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.

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

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: HIPP
* Behavioral: Wellness contact control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIPP Intervention<br>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. | Behavioral: HIPP<br>* 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.<br>|
| Active Comparator: Wellness Contact Control<br>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. | Behavioral: Wellness contact control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview) | 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) | minutes/week of moderate intensity or greater physical activity | baseline and 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Cancer Prevention