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Completed

NCT Number: NCT02574689

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

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.

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Key information

Age range

50 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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:

  • current stage of motivational readiness for physical activity;
  • increasing self- efficacy (i.e., confidence) for physical activity participation;
  • weighing the pros and cons of engaging in physical activity (decisional balance);
  • social support from family and friends for physical activity participation;
  • outcome expectations (beliefs regarding the consequences of physical activity participation);
  • perceived enjoyment of physical activity;
  • how the participant compares to her prior responses (progress feedback);
  • how the participant compares to individuals who are physically active and with national guidelines (normative feedback);
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)

    Time frame: 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)

    Time frame: baseline and 12 months

    minutes/week of moderate intensity or greater physical activity

Secondary outcomes

  1. 6 minute walk test

    Time frame: baseline, 6 months, 12 months

    meters walked in 6 minutes

  2. body mass index

    Time frame: baseline, 6 months, 12 months

    kg/m^2

  3. waist circumference

    Time frame: baseline, 6 months, 12 months

    cm

  4. body impedance analyses

    Time frame: baseline, 6 months, 12 months

    % body fat

  5. Social Support for exercise scale

    Time frame: 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

    Time frame: baseline, 6 months, 12 months

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

  7. Physical Activity Enjoyment scale

    Time frame: baseline, 6 months, 12 months

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

  8. accelerometers

    Time frame: baseline, 6 months, 12 months

    minutes/week of moderate intensity or greater physical activity

  9. Stages of Readiness Measure

    Time frame: baseline, 6 months, 12 months

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

  10. Self -Efficacy for physical activity scale

    Time frame: baseline, 6 months, 12 months

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

  11. processes of change measure

    Time frame: 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

    Time frame: baseline, 6 months, 12 months

    scores >0 indicate more advantages than disadvantages to physical activity

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Acronym: HIPP

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2015
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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