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Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients

7 de junio de 2019 actualizado por: University of Nebraska Lincoln
In this project the investigators examined the impact of diabetes self-management education using text messaging on increasing awareness of CVD risk perception, dietary intake, physical activity, and diabetes self-management among adults with type 2 diabetes using a quasi experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or older). The recruited adult type 2 diabetes patients were assigned into the intervention group (40 participants) and control group (39 participants). The intervention group received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages were derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise") Text messages were positive and motivating and included a link to a specific AADE7 handout that allows participants to open and retrieve the specific AADE7 handout. The control group did not receive text messages. The participants (both intervention and control group) completed surveys at baseline (before study begins) and at the conclusion of the study (at three month of the intervention) about their dietary and lifestyle habits, diabetes self-care management activities, and awareness of cardiovascular diseases. We collected also collect patient's self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three month of the intervention).

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Type 2 diabetes and its complications have become an important public health problem, affecting nearly 350 million adults worldwide. However, successfully managing type 2 diabetes through proper nutrition and healthy lifestyles remains challenging for many diabetes patients. In this proposed project the investigators examined the impact of diabetes self-management education using text messaging on increasing awareness of CVD risk perception, dietary intake, physical activity, and diabetes self-management, and quality of life among adults with type 2 diabetes among adults with Type 2 diabetes using a quasi experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or older). Inclusion criteria for the study sample of adult type II diabetes patients were: adults ages 30 or older, English speaking, and Hemoglobin A1C levels > 6.5%.

Adult type 2 diabetes patients were recruited from the Center for Diabetes & Nutritional Health, an outpatient diabetes clinic of Methodist Hospital in Omaha with the assistance of Certified Diabetes Educators and Registered Dietitians. Diagnosis of type 2 diabetes were based on patient self-report and verified by the Co-Primary Investigator (who is Certified Diabetes educator and registered dietitian at the Methodist Hospital. The recruited adult type 2 diabetes patients were assigned into the intervention group (40 participants) and control group (39 participants). The intervention group received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages were derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise") Text messages were positive and motivating and included a link to a specific AADE7 handout that allows participants to open and retrieve the specific AADE7 handout. Text messages were sent by the project investigators to the participants in the intervention group via a free computer-based text messaging service. The computer was password protected and can only be accessed by the investigators. Participant's phone numbers used for text message intervention were kept private. Only investigators and research assistant know the participant's cell phone numbers used for text message intervention and each participant's cell number was not shared with anyone else including other study participants. Text messages were sent by the project investigators or research assistant to the patients and were one-way text messages, meaning that patient did not need to reply to the text messages. If a patient had a medical concern about his/her diabetes, he/she was advised not to send a text message to the investigator, but to contact his/her physician or call 911 instead. The control group did not receive text messages. The participants (both intervention and control group) completed surveys at baseline (before study begins) and at the conclusion of the study (at three month of the intervention) about their dietary and lifestyle habits, diabetes self-care management, awareness of cardiovascular diseases and home food environment. The investigators also collected patient's self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three month of the intervention).

Tipo de estudio

Intervencionista

Inscripción (Actual)

79

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

    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68583-0806
        • University of Nebraska-Lincoln (with Methodist Hospital System)

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

30 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Self-report adult type 2 diabetes patients
  • Adults ages 30 or older
  • English speaking
  • Self-report Hemoglobin A1C > 6.5%
  • Have a cell phone able to receive text messages

Exclusion Criteria:

  • Individuals without Type 2 diabetes
  • Less than 30 years of age
  • Self-report Hemoglobin A1C less than 6.5%
  • Does not have a cell phone to receive text messages
  • Individuals who don't speak and understand English

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: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Text messaging
Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).
The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise"). The control group will not receive text messages
Sin intervención: Control
Participants will not receive text message intervention. This is the measurement-only group

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-Care Activities: Healthy Eating
Periodo de tiempo: Three months
An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)
Three months
Diabetes Self-care Activity: Exercise
Periodo de tiempo: Three months
Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)
Three months
Self-care Activity: Blood Glucose Testing
Periodo de tiempo: three months
Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)
three months
Self-care Activity: Medication Adherence
Periodo de tiempo: three months
Self-report survey question (days over the last seven days)
three months
Self-care Activity: Foot Care
Periodo de tiempo: three months
Average of four self-report survey questions of the category (days over the last seven days)
three months
Eat >= 5 Servings Fruit and Vegetables
Periodo de tiempo: Three months
Self report survey question (days/week)
Three months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-report Hemoglobin A1C
Periodo de tiempo: Three months
Self-report hemoglobin for diabetes status
Three months
Frequency of Concern of CVD Event
Periodo de tiempo: Three months
Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event
Three months
Total Carbohydrate
Periodo de tiempo: One month
A self-report food frequency questionnaire over the past month
One month
Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity
Periodo de tiempo: Three months
A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity
Three months
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years
Periodo de tiempo: Three months
Self report survey question
Three months
Degree of Concern of CVD Event in Lifetime
Periodo de tiempo: Three months
Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime
Three months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Weiwen Chai, PhD, University of Nebraska Lincoln

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.

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)

28 de febrero de 2017

Finalización primaria (Actual)

31 de mayo de 2018

Finalización del estudio (Actual)

31 de mayo de 2018

Fechas de registro del estudio

Enviado por primera vez

24 de enero de 2017

Primero enviado que cumplió con los criterios de control de calidad

30 de enero de 2017

Publicado por primera vez (Estimar)

1 de febrero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de junio de 2019

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

7 de junio de 2019

Última verificación

1 de junio de 2019

Más información

Términos relacionados con este estudio

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. .

Ensayos clínicos sobre Diabetes Mellitus, Tipo 2

Ensayos clínicos sobre Text messaging

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