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Habit Formation in Older Adults: Feasibility Study

3 de febrero de 2021 actualizado por: Young Joo Kim, East Carolina University

Forming New Habits: A Feasibility Study on an Intervention to Decrease Sedentary Behaviors in Medically Stable Older Adults

Sedentary behavior, which is characterized by too much sitting, is an epidemic in the United States. It is estimated that 4 out of every 10 Americans never engage in physical activity, and approximately 60% of an adult's non-sleeping hours are spent in sedentary behaviors. This equates to approximately 9-10 hours per day. As sedentary behavior increases, so do diagnoses of chronic illnesses such as diabetes, hypertension, cardiovascular disease, and kidney disease. Older adults are particularly at risk for sedentary behavior and the related chronic illnesses.

The primary aim of this study is to investigate the feasibility of implementing the EMA intervention with medically stable older adults who are living in the community.

The secondary aims of this study are to investigate the effectiveness of the Everyday Meaningful Activities (EMA) Intervention in forming active lifestyle behavior habits and in decreasing an individual's perceived sedentary time.

This prospective study will examine the ability of medically stable older adults to decrease sedentary behavior by creating new, active lifestyle behavior habits using the Everyday Meaningful Activities intervention. The EMA Intervention is based in Habit Formation Theory. It is an individualized, client-centered intervention that aims to increase adherence to active lifestyle behaviors in older adults' lives. Participants will engage in the EMA Intervention that is designed to create new active lifestyle behavior habits by attaching these new active lifestyle behaviors to currently existing daily routines.

During six intervention sessions over six weeks, participants will select two new active lifestyle behaviors to make habitual and will create action plans to create the habits. The first behavior will be implemented at the first intervention session, and the second behavior will be implemented at the fourth session. The participants will be assessed three times over their 8 to 10-week study participation. Participants should (1) be 65 years of age and older, (2) have intact cognition, (3) have no self-reported physical activity limitations, (4) have a sedentary lifestyle, and (5) have no acute illnesses or unstable medical conditions.

The results of this study may provide evidence for the occupational therapy intervention to decrease sedentary behavior in older adults in the community. The results may also broaden the scope of occupational therapy practice through demonstrating the potential for occupational therapy services in preventive health care.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Actual)

12

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

    • North Carolina
      • Greenville, North Carolina, Estados Unidos, 57834
        • East Carolina University

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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • age 65 or older,
  • intact cognition as confirmed by the Montreal Cognitive Assessment blind version
  • no physical activity restrictions that can be self-reported
  • sedentary lifestyle as confirmed by the Rapid Assessment Disuse Index
  • live within 20 miles of the College of Allied Health Sciences at ECU
  • have access to the internet and/or a telephone for remote intervention sessions

Exclusion Criteria:

  • acute or terminal illness
  • myocardial infarction in the previous 6 months
  • unstable cardiovascular disease
  • unstable metabolic disease
  • neuromusculoskeletal disorders that severely impact voluntary movement
  • limb amputation
  • upper or lower extremity fracture in the previous 3 months
  • current symptomatic hernia
  • current symptomatic hemorrhoids
  • cognitive impairment

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment rate
Periodo de tiempo: Through study completion, an average of 1 year
The recruitment rate for medically stable older adults in the community for this study
Through study completion, an average of 1 year
Appropriateness of the Rapid Assessment Disuse Index (RADI)
Periodo de tiempo: During screening
The appropriateness of the Rapid Assessment Disuse Index (RADI) for screening sedentary behavior in older adults over the phone
During screening
Appropriateness of the Short Blessed Test
Periodo de tiempo: During screening
the appropriateness of the Short Blessed Test for screening sufficient cognitive ability in older adults over the phone
During screening
Appropriateness of video conferencing through WebEx on an iPad
Periodo de tiempo: For 6 weeks
The appropriateness of video conferencing through WebEx on an iPad as an acceptable delivery method of selected intervention sessions
For 6 weeks
Reliability of participants' subjective reports
Periodo de tiempo: For 6 weeks
The reliability of participants' subjective reports of exact times for performing active lifestyle behaviors
For 6 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in the Self-Report Habit Index
Periodo de tiempo: 1) intervention session 1 at Week 1; 2) intervention session 4 at Week 4, and 3) posttest at Week 7
The Self-Report Habit Index (SRHI) measures features of habits including repetition, automaticity, and expressing identity. This 12-item assessment assesses the strength of habits by differentiating habit strength from behavior frequency. The participants will choose two active lifestyle behaviors to incorporate into their daily lives. The SRHI will generate pretest and posttest data for each behavior. The items in the SRHI began with the stem "Behavior X is something…" and is then followed by 12 statements rated on a scale from 1 (very strongly agree) to 7 (very strongly disagree). A total score ranges from 1 to 84 with lower scores indicating stronger habits.
1) intervention session 1 at Week 1; 2) intervention session 4 at Week 4, and 3) posttest at Week 7
Changes in Sedentary Behavior Questionnaire
Periodo de tiempo: 1) intervention session 1 at Week 1, and 2) posttest at Week 7
The Sedentary Behavior Questionnaire (SBQ) is a self-report questionnaire about time spent in sedentary behaviors both on weekdays and weekends. There are 9 identical items on the weekday form and the weekend form. Participants will complete both forms at both time points. The SBQ is used to assess the participants' perceived sedentary time. A total score ranges from 0 to 54 for each (weekday and weekend), with higher scores indicating more sedentary behaviors.
1) intervention session 1 at Week 1, and 2) posttest at Week 7

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Young Joo Kim, PhD, East Carolina University

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 (Actual)

1 de agosto de 2019

Finalización primaria (Actual)

6 de marzo de 2020

Finalización del estudio (Actual)

6 de marzo de 2020

Fechas de registro del estudio

Enviado por primera vez

24 de julio de 2019

Primero enviado que cumplió con los criterios de control de calidad

29 de julio de 2019

Publicado por primera vez (Actual)

30 de julio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de febrero de 2021

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

3 de febrero de 2021

Última verificación

1 de febrero de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • UMCIRB 19-001365

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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