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Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings

30 de abril de 2019 actualizado por: Dr. Meizi He, The University of Texas at San Antonio
The present study proposes to test the effectiveness of the Building a Healthy Temple: Diabetes Self-Management Support Program (BHT DSMS), a rendition of the Stanford DSMP in a spiritual context for the Hispanic faith community members. Using a holistic approach through integrating spiritual and physical health, BHT translates the Stanford DSMP in a way that may result in lasting behavior changes and improved diabetes outcomes for Hispanics with type 2 diabetes (T2D).

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

The present study is proposing a 12-month translational study BHT DSMS to test the effectiveness of adapted Stanford DSMP in a spiritual context. A cluster randomized trial with repeated measures will be conducted to compare the effectiveness of DSMS intervention strategies among 360 adult diabetic congregants from 18 predominantly Hispanic churches in San Antonio, Texas (20 participants/church). Using cluster randomized trial design; nine churches will be randomly assigned to the Faith-Based (FB) intervention, and nine to the Faith-Placed (FP) intervention. The study will be implemented in two cohorts (8 churches for cohort 1 & 10 churches for cohort 2). All intervention activities will be implemented over 14 consecutive weeks. Participants in the FB group will participate in BHT DSMS, which includes a Health Sermon, a 6-session Health Bible Study with cooking demonstrations, the Stanford DSMP and a Diabetes Resource Seminar delivered by two trained church lay leaders. Participants in the FP group will first attend a 7-session community health and safety curriculum as a partial attention control intervention, followed by the Stanford DSMP and Diabetes Resource Seminar facilitated by the local public health department. The primary outcome will be a change in HbA1c levels. Secondary outcomes include: changes in body mass index (BMI), waist circumference (WC), quality of life, diabetes self-care behaviors, eating behavior and physical activity level. Data will be collected at baseline, 6, 9, and 12-months during the study period. The aims of present study are 1) To test feasibility of the Stanford DSMP in FP and FB settings through observation and documentation of the implementation process, in-depth interviews with program staff and focus groups with participants to identify facilitators and barriers of the intervention. 2) To translate Stanford DSMP in a spiritual context for Hispanic faith community members and compare the effectiveness of a FB versus FP approach in improving diabetes outcomes.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

360

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.

Estudio Contacto

  • Nombre: Meizi He, PhD
  • Número de teléfono: 210-458-5416
  • Correo electrónico: meizi.he@utsa.edu

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Texas
      • San Antonio, Texas, Estados Unidos, 78249
        • Reclutamiento
        • Human Nutrition Lab, UTSA
        • Contacto:
          • Meizi He, PhD
          • Número de teléfono: 210-458-5416
          • Correo electrónico: meizi.he@utsa.edu
        • Contacto:
          • Christian Umana, B.Sc.
          • Número de teléfono: 210-458-7408
          • Correo electrónico: c.umana424@gmail.com
        • Investigador principal:
          • Meizi He, PhD

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

21 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Church eligibility: [Churches must be predominantly Hispanics (60%) with at least 20 adult congregants with T2D willing to participate in the study. The rationale for 20 diabetic voluntary participants per church is based on the Stanford requirement of 12-16 participants allowed per support group and with an anticipated 25% attrition.]
  • Participants' eligibility: Participants will be adults age 21 and above that have been diagnosed with T2D.

Exclusion Criteria:

  • Children, adults under 21 years of age, and pregnant women

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Faith-Based (FB, BHT DSMS)
The BHT DSMD intervention strategies adapted Stanford DSMP in a spiritual context is used in this group. Participants in the FB group will participate in BHT DSMS, which includes a Health Sermon, a 6-session Health Bible Study with cooking demonstrations, the Stanford DSMP and a Diabetes Resource Seminar delivered by two trained church lay leaders.
Conductual: Faith-Based (FB, BHT DSMS)
BHT DSMS Intervention components include Health Sermon and a 6-session Health Bible Study with cooking demonstrations, followed by the Stanford DSMP and a Diabetes Resource Seminar. All intervention activities are implemented by trained church lay leaders.
Comparador activo: Faith-Placed (FP, Stanford DSMP)
The traditional Stanford DSMP is conducted in this control group. Participants in the FP group will first attend a 7-session community health and safety curriculum as a partial attention control intervention, followed by the Stanford DSMP and Diabetes Resource Seminar facilitated by the local public health department.
Otro: Faith-Placed (FP, Stanford DSMP)
Standard Stanford DSMP delivered by health professional

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The change in HbA1c
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
A finger-prick blood sample will be collected for HbA1c testing using Metrika A1cNowTM (Bayer Health Care).
Data is collected at baseline, 6, 9, and 12-months during the study period.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Waist circumference
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
waist circumference (WC) will measured in the horizontal plane midway between the lowest rib and the iliac crest.
Data is collected at baseline, 6, 9, and 12-months during the study period.
Body Mass Index
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
Participants' body weight and height will be measured. BMI will be calculated height and weight (kg/M2)
Data is collected at baseline, 6, 9, and 12-months during the study period.
Quality of Life (QoL)
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
Quality of life in present study will be measured using the Problem Areas in Diabetes (PAID) scale (Polonsky and Anderson, 1995). The PAID measure of diabetes related emotional distress correlates with measures of related concepts such as depression, social support, health beliefs, and coping style, as well as predicts future blood glucose control of the patient. Questionnaire scale scoring: Each question has 5 possible answers with a value from 0 to 4, with 0 representing "no problem" and 4 "a serious problem". The scores are added up and multiplied by 1.25, generating a total score between 0 - 100. Patients scoring 40 or higher may be at the level of "emotional burnout" and warrant special attention. PAID scores in these patients may drop 10-15 points in response to
Data is collected at baseline, 6, 9, and 12-months during the study period.
Diabetes Self-care practices
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
The Revised Summary of Diabetes Self-Care Activities (SDSCA) (Toobert, Hampson, and Glasgow, 2000). It is a 25-item self-report measure of the frequency of performing diabetes self-care tasks over the preceding 7 days. The response is based on a seven-point Likert scale to answer the question phrased as "On how many of the last 7 days did you…?". Higher overall scores reflect good diabetes self-care practice.
Data is collected at baseline, 6, 9, and 12-months during the study period.
The barriers to diabetes care.
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
The barriers to diabetes care are investigated using selected questions from the National Survey of People with Diabetes (Harris, McGee, and Andrews, 2007).
Data is collected at baseline, 6, 9, and 12-months during the study period.
Physical Activity (PA) level assessment
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
A 6-item Exercise Behaviors scale (Lorig et al 1996) measures total minutes per week of aerobic and nonaerobic exercise specifically over the past seven days. The first question measures the amount of time that the participant stretched or engaged in any strengthening exercises. The other five questions measures aerobic activity. The options for the questions include none, less than 30 minutes per week, 30-60 minutes per week, 1-3 hours per week, and more than 3 hours per week. The total aerobic and stretching and/or strengthening minutes were calculate by converting the "None" category to 0 minutes; "Less than 30 minutes/week" into 15 minutes; "30-60 minutes/week" into 45 minutes; "1-3 hours/week" into 120 minutes; and "More than 3 hours/week" into 180 minutes.(6) The response to the first question was used to determine the amount of time for stretching/strengthening while questions 2 through 6 were summed together to determine the amount of aerobic time.
Data is collected at baseline, 6, 9, and 12-months during the study period.
Occupational physical activity
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
Occupational physical activity also is evaluated using a single-item question recommended by Behavioral Risk Factor Surveillance System (BRFSS) which is designed to categorize occupational physical activity into three components: 1) mostly sitting and standing (inactivity and low-intensity activity); 2) mostly waling (moderate-intensity activity); or 3) mostly heavy labor (vigorous-intensity activity) (www.cdc.gov/brfss/; Yore MM, Bowles HR, 2006)
Data is collected at baseline, 6, 9, and 12-months during the study period.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Diabetes self-efficacy
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
Diabetes self-efficacy scale will assess participants' diabetes self-efficacy (Sarkar, Fisher and Schillinger, 2006). It is an 8-item instrument assessing diabetic individual's self-management efficacy. These items addressed diabetes-specific domains such as confidence in self-monitoring of blood glucose (SMBG), as well as general health domains such as confidence in ability to get medical attention and take care of health using 4-point Likert-scale with responses from "1 = not at all sure" to "4 = very sure." For each item patients rated their confidence in their ability to perform a recommended self-care routine. The overall self-efficacy score are transformed to a 100-point scale with a higher score representing greater self-efficacy.
Data is collected at baseline, 6, 9, and 12-months during the study period.
Social support in a spiritual context
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
Social support in a religion context will be measured using the instrument by Olphen et al.(2003) that assess the frequency with which participants receive support from other church members by asking "How often do people in your church or place of worship help you out? The answer options include "1= never; 2= hardly ever; 3= not too often; 4= fairly often and 5= very". Higher scores indicate greater levels of level of support.
Data is collected at baseline, 6, 9, and 12-months during the study period.
Social support for diabetes self-management
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
• Social support for self-management will be assessed using modified Social Support Scale for Self-care in Middle-aged patients with type II diabetes (S4-MAD) (Naderimagham S, Niknami S, 2012) The questions in S4-MAD will be re-classified to evaluate the social support in emotional and information support, tangible support, affectionate support, positive support and additional support (www.rand.org). The social support resources include "Are you attending worship service at this church?", "Who help you the most in caring for your diabetes outside of church?", "Who helps you the most I caring for your diabetes within the church?". The responses will be "1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; 5 = Always". The higher score reflects better spiritual coping.
Data is collected at baseline, 6, 9, and 12-months during the study period.
Spiritual coping
Periodo de tiempo: Data is collected at baseline, 6, 9, and 12-months during the study period.
Spiritual coping in the DSMP context will be measured by adapting the RCOPE (Pargament, Koenig, and Perez) instrument particularly measuring spiritual coping strategies identified by diabetic individuals. Areas include "I pray to and believe in God", "God keeps me alive", "I turn things over to God", "God changes my unhealthy behaviors", "God supplies my needs", "I read the Bible", and "I ask religious or spiritual individuals help me". The responses will be "1 = Not at all; 2 = Somewhat; 3 = Quite a bit; 4 = A great deal". The higher score reflects better spiritual coping.
Data is collected at baseline, 6, 9, and 12-months during the study period.

Colaboradores e Investigadores

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

Patrocinador

The University of Texas at San Antonio

Colaboradores

American Diabetes Association

Investigadores

  • Investigador principal: Meizi He, PhD, The University of Texas at San Antonio

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

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 enero de 2017

Finalización primaria (Anticipado)

30 de junio de 2020

Finalización del estudio (Anticipado)

30 de junio de 2020

Fechas de registro del estudio

Enviado por primera vez

27 de marzo de 2019

Primero enviado que cumplió con los criterios de control de calidad

30 de abril de 2019

Publicado por primera vez (Actual)

2 de mayo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de mayo de 2019

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

30 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ADA#1-17-ICTS-029

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Sí

Descripción del plan IPD

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Marco de tiempo para compartir IPD

Data will be available in December 2020.

Criterios de acceso compartido de IPD

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

Tipo de información de apoyo para compartir IPD

  • Protocolo de estudio
  • Plan de Análisis Estadístico (SAP)
  • Formulario de consentimiento informado (ICF)
  • Informe de estudio clínico (CSR)
  • Código analítico

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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