- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02919397
Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
Effectiveness of Integrating Motivational Instant Messaging Into an E-diabetes Prevention Programme in People at High Risk of Type 2 Diabetes: a Prospective, Parallel-group, Randomised Controlled Trial (Diabetes Stopwatch)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The study will examine whether a wearable technology, combined with biofeedback, motivational messaging and an e-diabetes prevention programme, is effective in reducing weight and increasing physical activity after 12 months.
The intervention will consist of a wearable technology and a smartphone application made available for a 12 month period. 22 online multimedia sessions targeting diet, physical activity and mental resilience delivered via the smartphone application. Motivational messaging based on the diabetes prevention module content and biofeedback will be sent to participants via the application.
The control group will receive the wearable technology and will have access to a smartphone application detailing their activity. Participants will be directed to the same educational material as is made available via the multimedia sessions, but will not receive motivational messages.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- HbA1c between 42 and 47 mmol/mol
- BMI≥25 kg/m²
- Fluent in conversational English
- Permanent resident in Lambeth, Southwark or Lewisham
- Ownership of a smartphone (iPhone or Android only) for communication defined as logging on at least once/day to the internet
- Ambulatory.
Exclusion Criteria:
- Known diabetes
- Pregnancy or planning pregnancy during the duration of the study
- Severe mental illness (severe depression, psychosis, bipolar affective disorder, dementia, learning difficulties, substance problem use or dependence)
- Severe physical disability e.g. that would prevent any increased uptake of physical exercise
- Advanced active disease such as cancer or heart failure
- Any other condition which requires glucose altering drugs
- Morbid obesity (BMI ≥50 kg/m²)
- Current participation in a weight loss programme.
When in doubt the investigators will seek the GP opinion and approval.
Plan de estudios
¿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 |
---|---|
Experimental: Intervention
If participants are allocated to the intervention group, participants will receive the wearable technology and access to the smartphone application.
Motivational messages based on diabetes prevention programme content, and biofeedback messages based on physical activity data provided via the wearable technology, will be received by participants via the application.
The diabetes prevention programme educational material will be available via the application.
|
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
Educational material accessed through smartphone application
Messages sent via smartphone application
|
Comparador activo: Control
If participants are allocated to the control group, participants will receive the wearable technology and will be able to access their activity data via the smartphone application.
Participants will also have have access to the diabetes prevention programme educational material via the application.
Participants will not receive motivational messages related to the education content or activity data.
|
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
Educational material accessed through smartphone application
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Physical activity (average steps per day)
Periodo de tiempo: 7 days
|
Average steps taken per day from 7 days wear measured using the Buddi wearable technology, which will be worn 24 hours per day for 7 days
|
7 days
|
Weight (kg)
Periodo de tiempo: At 12 month follow-up appointment
|
Measured in light clothing, without shoes, on the a Class 3 Tanita SC240 weighing digital scale to 0.01 kg for weight
|
At 12 month follow-up appointment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HbA1c (mmol/mol)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
Height (cm)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
BMI (kg/m^2)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
Waist circumference (cm)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
Hip circumference (cm)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
Total cholesterol (mmol/L)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
High density lipoprotein cholesterol (mmol/L)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
Low density lipoprotein cholesterol (mmol/L)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
Systolic blood pressure (mmHg)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
Diastolic blood pressure (mmHg)
Periodo de tiempo: At 12 month follow-up appointment
|
At 12 month follow-up appointment
|
|
Sleep duration (average hours per night)
Periodo de tiempo: 7 days
|
The Buddi wearable technology will be worn for 24 hours per day.
Therefore, during sleeping hours participant activity will be measured and duration of sleep can be calculated.
Participants will wear the Buddi device for 7 days, and the average number of hours sleep per night will be calculated.
|
7 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Khalida Ismail, King's College London
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 197384
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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