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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT02574689
Collaborator
American Cancer Society, Inc. (Other)
83
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2
63
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HIPP
  • Behavioral: Wellness contact control
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
83 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview) [baseline and 6 months]

    minutes/week of moderate intensity or greater physical activity

  2. 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

  1. 6 minute walk test [baseline, 6 months, 12 months]

    meters walked in 6 minutes

  2. body mass index [baseline, 6 months, 12 months]

    kg/m^2

  3. waist circumference [baseline, 6 months, 12 months]

    cm

  4. body impedance analyses [baseline, 6 months, 12 months]

    % body fat

  5. 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

  6. Outcome expectations scale [baseline, 6 months, 12 months]

    range= 1-5, with higher scores representing more outcome expectations

  7. Physical Activity Enjoyment scale [baseline, 6 months, 12 months]

    range=18-126, with higher scores indicating more enjoyment

  8. accelerometers [baseline, 6 months, 12 months]

    minutes/week of moderate intensity or greater physical activity

  9. Stages of Readiness Measure [baseline, 6 months, 12 months]

    categorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)

  10. Self -Efficacy for physical activity scale [baseline, 6 months, 12 months]

    range= 1-5, with higher scores representing more self-efficacy

  11. 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

  12. Decisional Balance scale [baseline, 6 months, 12 months]

    scores >0 indicate more advantages than disadvantages to physical activity

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 69 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35233

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Dori Pekmezi, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dorothy Pekmezi, PhD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02574689
Other Study ID Numbers:
  • X130405004
First Posted:
Oct 14, 2015
Last Update Posted:
Apr 21, 2020
Last Verified:
Apr 1, 2020
Keywords provided by Dorothy Pekmezi, PhD, Assistant Professor, University of Alabama at Birmingham

Study Results

No Results Posted as of Apr 21, 2020