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

17. April 2020 aktualisiert von: Dorothy Pekmezi, PhD, University of Alabama at Birmingham
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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

83

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • University of Alabama at Birmingham

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre bis 69 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
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.
Aktiver Komparator: 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.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
Zeitfenster: baseline and 6 months
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)
Zeitfenster: baseline and 12 months
minutes/week of moderate intensity or greater physical activity
baseline and 12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
6 minute walk test
Zeitfenster: baseline, 6 months, 12 months
meters walked in 6 minutes
baseline, 6 months, 12 months
body mass index
Zeitfenster: baseline, 6 months, 12 months
kg/m^2
baseline, 6 months, 12 months
waist circumference
Zeitfenster: baseline, 6 months, 12 months
cm
baseline, 6 months, 12 months
body impedance analyses
Zeitfenster: baseline, 6 months, 12 months
% body fat
baseline, 6 months, 12 months
Social Support for exercise scale
Zeitfenster: baseline, 6 months, 12 months
range=0-65 for both friends and family subscales, with higher scores indicating more social support
baseline, 6 months, 12 months
Outcome expectations scale
Zeitfenster: baseline, 6 months, 12 months
range= 1-5, with higher scores representing more outcome expectations
baseline, 6 months, 12 months
Physical Activity Enjoyment scale
Zeitfenster: baseline, 6 months, 12 months
range=18-126, with higher scores indicating more enjoyment
baseline, 6 months, 12 months
accelerometers
Zeitfenster: baseline, 6 months, 12 months
minutes/week of moderate intensity or greater physical activity
baseline, 6 months, 12 months
Stages of Readiness Measure
Zeitfenster: baseline, 6 months, 12 months
categorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)
baseline, 6 months, 12 months
Self -Efficacy for physical activity scale
Zeitfenster: baseline, 6 months, 12 months
range= 1-5, with higher scores representing more self-efficacy
baseline, 6 months, 12 months
processes of change measure
Zeitfenster: baseline, 6 months, 12 months
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
Zeitfenster: baseline, 6 months, 12 months
scores >0 indicate more advantages than disadvantages to physical activity
baseline, 6 months, 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Dori Pekmezi, PhD, University of Alabama at Birmingham

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2014

Primärer Abschluss (Tatsächlich)

1. Dezember 2019

Studienabschluss (Tatsächlich)

1. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

15. September 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Oktober 2015

Zuerst gepostet (Schätzen)

14. Oktober 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. April 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. April 2020

Zuletzt verifiziert

1. April 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • X130405004

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