Overview

This trial is active, not recruiting.

Condition physical activity
Treatments hipp, wellness contact control
Sponsor University of Alabama at Birmingham
Collaborator American Cancer Society, Inc.
Start date September 2014
End date January 2018
Trial size 80 participants
Trial identifier NCT02574689, X130405004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
hipp
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.
(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.
wellness contact control
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.

Primary Outcomes

Measure
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
time frame: baseline and 6 months
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
time frame: baseline and 12 months

Secondary Outcomes

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

Eligibility Criteria

Female participants from 50 years up to 69 years old.

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

Additional Information

Official title Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South
Principal investigator Dori Pekmezi, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.