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

Physical Activity Clinical Trial

— HIPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574689
• Other study ID #: X130405004
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	6 minute walk test	meters walked in 6 minutes	baseline, 6 months, 12 months
Secondary	body mass index	kg/m^2	baseline, 6 months, 12 months
Secondary	waist circumference	cm	baseline, 6 months, 12 months
Secondary	body impedance analyses	% body fat	baseline, 6 months, 12 months
Secondary	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
Secondary	Outcome expectations scale	range= 1-5, with higher scores representing more outcome expectations	baseline, 6 months, 12 months
Secondary	Physical Activity Enjoyment scale	range=18-126, with higher scores indicating more enjoyment	baseline, 6 months, 12 months
Secondary	accelerometers	minutes/week of moderate intensity or greater physical activity	baseline, 6 months, 12 months
Secondary	Stages of Readiness Measure	categorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)	baseline, 6 months, 12 months
Secondary	Self -Efficacy for physical activity scale	range= 1-5, with higher scores representing more self-efficacy	baseline, 6 months, 12 months
Secondary	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
Secondary	Decisional Balance scale	scores >0 indicate more advantages than disadvantages to physical activity	baseline, 6 months, 12 months