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

Not Applicable

Completed

• Conditions: Physical Activity
• Interventions: Behavioral: HIPP; Behavioral: Wellness contact control

• Registration Number: NCT02574689
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-14
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIPP Intervention	HIPP	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.
Wellness Contact Control	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.

Primary Outcome Measures

Name	Time	Method
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)	baseline and 12 months	minutes/week of moderate intensity or greater physical activity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States