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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02574689
Acronym
HIPP
Enrollment
83
Registered
2015-10-14
Start date
2014-09-30
Completion date
2019-12-31
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

Physical Activity, Cancer Prevention

Brief summary

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

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.

Interventions

BEHAVIORALHIPP

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.

Sponsors

American Cancer Society, Inc.
CollaboratorOTHER
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 69 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)baseline and 6 monthsminutes/week of moderate intensity or greater physical activity

Secondary

MeasureTime frameDescription
body mass indexbaseline, 6 months, 12 monthskg/m\^2
waist circumferencebaseline, 6 months, 12 monthscm
body impedance analysesbaseline, 6 months, 12 months% body fat
Social Support for exercise scalebaseline, 6 months, 12 monthsrange=0-65 for both friends and family subscales, with higher scores indicating more social support
Outcome expectations scalebaseline, 6 months, 12 monthsrange= 1-5, with higher scores representing more outcome expectations
6 minute walk testbaseline, 6 months, 12 monthsmeters walked in 6 minutes
accelerometersbaseline, 6 months, 12 monthsminutes/week of moderate intensity or greater physical activity
Stages of Readiness Measurebaseline, 6 months, 12 monthscategorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)
Self -Efficacy for physical activity scalebaseline, 6 months, 12 monthsrange= 1-5, with higher scores representing more self-efficacy
processes of change measurebaseline, 6 months, 12 monthsrange= 1-5, with higher scores representing greater use of cognitive and/or behavioral processes of change
Decisional Balance scalebaseline, 6 months, 12 monthsscores \>0 indicate more advantages than disadvantages to physical activity
Physical Activity Enjoyment scalebaseline, 6 months, 12 monthsrange=18-126, with higher scores indicating more enjoyment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026