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

NCT02574689 | Completed

• 1 other identifier: X130405004
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Keywords

Physical Activity; Cancer Prevention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 6 minute walk test

  baseline, 6 months, 12 months

• body mass index

  baseline, 6 months, 12 months

• waist circumference

  baseline, 6 months, 12 months

• body impedance analyses

  baseline, 6 months, 12 months

• Social Support for exercise scale

  baseline, 6 months, 12 months

Study Arms (2)

HIPP Intervention

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.

Behavioral: HIPP

Wellness Contact Control

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.

Behavioral: Wellness contact control

Interventions

HIPP BEHAVIORAL

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.

HIPP Intervention

Wellness contact control BEHAVIORAL

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.

Wellness Contact Control

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Dori Pekmezi, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: October 14, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

US (1)