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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: HIPP; Behavioral: Wellness contact control

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIPP Intervention; 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; 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: 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.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Dori Pekmezi, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Physical Activity; Cancer Prevention
• Other Study ID Numbers: X130405004