Live Your Life Without Diabetes
6 de septiembre de 2018 actualizado por: University of Aarhus
Effectiveness of a Brief Theory-based Health Promotion Intervention Among Adults at High Risk of Type 2 Diabetes: One-year Results From a Randomised Trial in a Community Setting
Aim: To examine the effect of a brief theory-based health promotion intervention delivered in the community on health behaviour and diabetes-related risk factors among Danish adults at high risk of diabetes.
Methods: A randomised trial was conducted among 127 individuals aged 28 to 70 with fasting plasma glucose: 6.1-6.9 mmol/l and/or HbA1c : 6.0-<6.5% (42- < 48 mmol/mol) recruited from general practice in Holstebro, Denmark. Participants were randomised to a control group or to receive the intervention delivered over four 2 h group sessions during five weeks, and two further sessions after one and six months. Questionnaire data and clinical measures were collected at baseline, three months and one year after intervention.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
127
Fase
- No aplica
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
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- resident in the Municipality of Holstebro
- aged <70 years
- a measurement of fasting plasma glucose: 6.1-6.9 mmol/l (the thresholds for Impaired Fasting Glucose according to clinical guidelines) and/or HbA1c : 6.0-<6.5% (42- <48 mmol/mol) within the previous six months.
Exclusion Criteria:
- none
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 |
|---|---|
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Experimental: Intervention
Participants in the intervention group received the offer of four 2h group sessions during five weeks, and two further sessions after one and six months.
The attendance rates of the sessions were 95%, 88%, 87%, 73%, 67% and 51%, respectively.
The course was delivered by health care staff in the Holstebro Health Care Centre, including a dietitian and an occupational therapist, both with health pedagogic competences.
It was delivered to seven intervention groups, which varied in size from 5 to 15 participants.
|
The intervention is depicted using a PaT Plot in the published paper: Juul, L et al.
Effectiveness of a brief theory-based health promotion intervention among adults at high risk of type 2 diabetes: One-year results from a randomised trial in a community setting.
Primary Care Diabetes 1 0 ( 2 0 1 6 ) 111-120.
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Sin intervención: Control
Usual practice
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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weight
Periodo de tiempo: baseline to one-year follow-up
|
change in weight / the proportion with weight reduction >5% of baseline weight at one-year
|
baseline to one-year follow-up
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total-fat intake <30% of energy intake
Periodo de tiempo: change from baseline to one-year follow-up
|
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ.
Portion size was set according to gender.
Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
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change from baseline to one-year follow-up
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|
saturated-fat intake <10% of energy intake
Periodo de tiempo: change from baseline to one-year follow-up
|
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ.
Portion size was set according to gender.
Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
|
change from baseline to one-year follow-up
|
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fibre-intake ≥15g/1000kcal changes in physical activity level.
Periodo de tiempo: change from baseline to one-year follow-up
|
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ.
Portion size was set according to gender.
Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
|
change from baseline to one-year follow-up
|
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changes in physical activity.
Periodo de tiempo: change from baseline to one-year follow-up
|
Physical activity was measured using the International Physical Activity Questionnaire (IPAQ).
Increased MET (min/week)=increased physical activity
|
change from baseline to one-year follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
patient activation
Periodo de tiempo: change from baseline to one-year follow-up
|
patient activation was measured using the Patient Activation Measure (PAM)
|
change from baseline to one-year follow-up
|
|
waist circumference
Periodo de tiempo: change from baseline to one-year follow-up
|
Waist circumference was recorded as the average of two measurements of waist circumference using a tape measure halfway between the lowest point of the rib cage and the anterior supe- rior iliac crests when standing.
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change from baseline to one-year follow-up
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total energy intake
Periodo de tiempo: change from baseline to one-year follow-up
|
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ.
Portion size was set according to gender.
Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
|
change from baseline to one-year follow-up
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blood pressure, systolic and diastolic
Periodo de tiempo: change from baseline to one-year follow-up
|
Systolic and diastolic blood pressure was calculated as the mean of three measurements performed after at least 10 min rest, while participants were seated with the cuff on the right arm at the level of the heart.
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change from baseline to one-year follow-up
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HbA1c
Periodo de tiempo: change from baseline to one-year follow-up
|
Blood tests were analysed in a central laboratory.
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change from baseline to one-year follow-up
|
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cholesterol
Periodo de tiempo: change from baseline to one-year follow-up
|
Total, LDL, HDL, Blood tests were analysed in a central laboratory.
|
change from baseline to one-year follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
19 de enero de 2011
Finalización primaria (Actual)
9 de enero de 2013
Finalización del estudio (Actual)
9 de enero de 2013
Fechas de registro del estudio
Enviado por primera vez
29 de agosto de 2018
Primero enviado que cumplió con los criterios de control de calidad
6 de septiembre de 2018
Publicado por primera vez (Actual)
10 de septiembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
6 de septiembre de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018-02-3065
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
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