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

17 de abril de 2020 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

83

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • University of Alabama at Birmingham

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 69 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
Periodo de tiempo: 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)
Periodo de tiempo: baseline and 12 months
minutes/week of moderate intensity or greater physical activity
baseline and 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6 minute walk test
Periodo de tiempo: baseline, 6 months, 12 months
meters walked in 6 minutes
baseline, 6 months, 12 months
body mass index
Periodo de tiempo: baseline, 6 months, 12 months
kg/m^2
baseline, 6 months, 12 months
waist circumference
Periodo de tiempo: baseline, 6 months, 12 months
cm
baseline, 6 months, 12 months
body impedance analyses
Periodo de tiempo: baseline, 6 months, 12 months
% body fat
baseline, 6 months, 12 months
Social Support for exercise scale
Periodo de tiempo: 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
Periodo de tiempo: baseline, 6 months, 12 months
range= 1-5, with higher scores representing more outcome expectations
baseline, 6 months, 12 months
Physical Activity Enjoyment scale
Periodo de tiempo: baseline, 6 months, 12 months
range=18-126, with higher scores indicating more enjoyment
baseline, 6 months, 12 months
accelerometers
Periodo de tiempo: baseline, 6 months, 12 months
minutes/week of moderate intensity or greater physical activity
baseline, 6 months, 12 months
Stages of Readiness Measure
Periodo de tiempo: 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
Periodo de tiempo: baseline, 6 months, 12 months
range= 1-5, with higher scores representing more self-efficacy
baseline, 6 months, 12 months
processes of change measure
Periodo de tiempo: 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
Periodo de tiempo: baseline, 6 months, 12 months
scores >0 indicate more advantages than disadvantages to physical activity
baseline, 6 months, 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Dori Pekmezi, PhD, University of Alabama at Birmingham

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2014

Finalización primaria (Actual)

1 de diciembre de 2019

Finalización del estudio (Actual)

1 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

15 de septiembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

13 de octubre de 2015

Publicado por primera vez (Estimar)

14 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de abril de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

17 de abril de 2020

Última verificación

1 de abril de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • X130405004

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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