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Call-2-Health: Preventing Type II Diabetes (C2H)

11 de octubre de 2017 actualizado por: Kaiser Permanente

Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting

It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing to this national trend is the obesity epidemic. Three randomized trials have demonstrated that intensive behavioral interventions can prevent or delay the onset of diabetes. The purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a population-based, telephonic, exercise and weight loss intervention to translate the findings of the Diabetes Prevention Program into practice. The telephonic intervention will be compared to usual care (30 participants in each group). The investigators will deliver the intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24 weeks.

For this planning grant the investigators do not have an overall hypothesis. The investigators' goal is to develop and test whether it is possible to do exercise and weight loss

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

47

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

  • Estados Unidos
    • Washington
      • Seattle, Washington, Estados Unidos, 98101
        • Group Health Research Institute

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

40 años a 74 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male or female
  • Age 40-74
  • Receives primary care at Group Health Central, Rainier, or Poulsbo clinics in the greater Seattle area
  • Can walk for more than 10 minutes
  • Fasting plasma glucose (FPG) 105-125 mg/dl or glycolated hemoglobin (HbA1C) 5.7-6.4
  • Body Mass Index (BMI) 25 kg/m2 or greater

Exclusion Criteria:

  • Type 1 or 2 diabetes
  • FPG > 125 mg/dl or < 105mg/dl at screening blood draw
  • HbA1C > 6.4 or < 5.7 at screening blood draw
  • Systolic blood pressure > 210 mmHg at the baseline clinic visit
  • Exercise ≥ 30 minutes/day, at least five days a week
  • Current participation in another structured weight loss treatment program or another intervention study
  • Severe concurrent disease
  • Unavailable for the 24-week study period
  • Unable to read or speak English
  • Pregnant or planning to become pregnant.
  • Mentally or legally incapacitated such that informed consent cannot be obtained.

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Intervention
Participants assigned to the intervention group worked with the study interventionist over the phone to reduce their risk for developing Diabetes Mellitus, Type 2. The intervention lasted for 24 weeks, with weekly phone calls for the first 12 weeks and 4 maintenance calls over the second 12 weeks. Study measurements were taken at baseline, 12 weeks, 24 weeks, and 52 weeks. After 24 weeks, the investigators randomly divided the intervention group in half. The first group did not receive any more phone calls from the interventionist. The second group continued to receive monthly 20-minute phone calls from the interventionist. At 52 weeks post-baseline participants from both groups had their labs drawn, wore a pedometer for 3 days, and called in with a self-reported weight.
Conductual: Telephonic intervention to prevent Diabetes Mellitus, Type 2
Participants assigned to the intervention group received a total of 16 phone calls from the study interventionist over 24 weeks. The first 12 weeks was the intervention phase and calls were made weekly. The second 12 weeks was the maintenance phase and calls were made every 3 weeks. After 24 weeks, the investigators continued to follow this group for 52 weeks post-randomization, allowing half of the group to continue to receive monthly maintenance calls while the other half received no further calls. The study interventionist used behavior modification techniques to encourage intervention group participants to adopt healthy eating and exercise habits so that improvement might be seen in fasting glucose, glycated hemoglobin (HbA1c), weight, and waist/hip measurements.
Sin intervención: Control
Participants randomized into this group did not receive any intervention, although they were encouraged to follow-up with their doctor and follow through with usual clinical care.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Program feasibility: Uptake
Periodo de tiempo: Baseline
Measured by the number of people who consent to be in the study compared to the number who were eligible
Baseline
Program feasibility: Attendance
Periodo de tiempo: 12 weeks
Measured by the number of participants who return for their 12 week clinic visit
12 weeks
Program feasibility: Attendance
Periodo de tiempo: 24 weeks
Measured by the number of participants who return for their 24 week clinic visit
24 weeks
Program feasibility: Attendance
Periodo de tiempo: 52 weeks
Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)
52 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fasting glucose
Periodo de tiempo: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
Waist circumference
Periodo de tiempo: Baseline, 12 weeks, 24 weeks
in centimeters
Baseline, 12 weeks, 24 weeks
Blood pressure
Periodo de tiempo: Baseline, 12 weeks, 24 weeks
Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)
Baseline, 12 weeks, 24 weeks
Healthy eating habits
Periodo de tiempo: Baseline, 12 weeks, 24 weeks
Assessed using the Food Frequency Questionnaire
Baseline, 12 weeks, 24 weeks
Weight loss
Periodo de tiempo: Baseline, 12 weeks, 24 weeks, 52 weeks
Weight measured in kilograms
Baseline, 12 weeks, 24 weeks, 52 weeks
Changes in activity
Periodo de tiempo: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured using the Modifiable Activity Questionnaire (MAQ)
Baseline, 12 weeks, 24 weeks, 52 weeks
Glycated hemoglobin (A1C)
Periodo de tiempo: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
Total cholesterol (TC)
Periodo de tiempo: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
High density lipoprotein (HDL)
Periodo de tiempo: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via a fasting blood draw
Baseline, 12 weeks, 24 weeks, 52 weeks
Low density lipoprotein (LDL)
Periodo de tiempo: Baseline, 12 weeks, 24 weeks, 52 weeks
Measured via fasting blood draw.
Baseline, 12 weeks, 24 weeks, 52 weeks
Body Mass Index (BMI)
Periodo de tiempo: Baseline, 12 weeks, 24 weeks, 52 weeks
Baseline, 12 weeks, 24 weeks, 52 weeks
Physical activity level
Periodo de tiempo: Baseline, 12 weeks, 24 weeks, 52 weeks
Participants wore a blinded pedometer for 3 days
Baseline, 12 weeks, 24 weeks, 52 weeks

Colaboradores e Investigadores

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

Patrocinador

Kaiser Permanente

Investigadores

  • Investigador principal: Katherine Newton, PhD, Group Health Research Institute

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 julio de 2010

Finalización primaria (Actual)

1 de octubre de 2011

Finalización del estudio (Actual)

1 de junio de 2012

Fechas de registro del estudio

Enviado por primera vez

11 de septiembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

5 de abril de 2013

Publicado por primera vez (Estimar)

10 de abril de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de octubre de 2017

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

11 de octubre de 2017

Última verificación

1 de octubre de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 184802-16

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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