‘Sit less and move more’ at work: Impact of an mHealth program on glycaemic control and anthropometric profile on office personnel with DT2. Randomised Clinical Trial (Q3141946)
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Project Q3141946 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | ‘Sit less and move more’ at work: Impact of an mHealth program on glycaemic control and anthropometric profile on office personnel with DT2. Randomised Clinical Trial |
Project Q3141946 in Spain |
Statements
11,500.0 Euro
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23,000.0 Euro
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50.0 percent
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1 January 2018
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31 March 2021
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FUNDACIO UNIVERSITÀRIA BALMES
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41°22'58.40"N, 2°10'38.75"E
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08019
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Objetivo. Impacto de un programa mHealth para ´sentarse menos y moverse más en el trabajo sobre el control glucémico y perfil antropométrico en personal de oficina con diabetes tipo 2 (DT2) a corto, medio y largo plazo. Métodos. Ensayo clínico controlado a doble ciego. Participaran 7 centros de atención primaria (n=5 Cataluña, n=2 Madrid), 2 hospitales (n=1 Cataluña, n=1 Madrid), 2 empresas (servicios de medicina laboral; n=1 pública, n=1 privada). En cada centro, médicos, enfermeras, endocrinos y médicos laborales reclutarán a pacientes con DT2 que trabajen en oficinas, permanezcan sentados al menos un 70% del horario laboral (OSPAQ) y dispongan de un dispositivo smartphone. Según criterios CONSORT (2010), un proceso de aleatorización simple-dirigido por el equipo investigador-asignará a los voluntarios a grupo control (GC) e intervención (GI) mediante generador computarizado de números aleatorios. Se estima necesario incluir 184 pacientes en cada grupo (n=368 total). Se analizarán: glucemia basal, HbA1c, peso, talla, IMC, y perímetro de cintura. Las variables de sedestación (horas de tiempo sentado laboral y número de interrupciones del tiempo sentado) se medirán mediante dispositivo ActivPal. Otras variables: actividad física (IPAQ corto), calidad de vida (EuroQool), presentismo laboral (WLQ), triglicéridos, colesterol total (LDL y HDL), presión arterial y variables sociodemográficas. Intervención: Basada en un programa mHealth (13 semanas) que reemplaza tareas laborales sedentarias por activas. El GC recibirá consejo habitual. Un análisis multivariado estudiará el cambio en el tiempo de las variables dependientes (post intervención, 6 y 12 meses) y se establecerán comparaciones entre GC y GI. Se realizarán por intención de tratar. (Spanish)
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Target. Impact of an mHealth program to 'feel less and move more into the work on glycaemic control and anthropometric profile on office personnel with type 2 diabetes (DT2) in the short, medium and long term. Methods. Double-blind controlled clinical trial. 7 primary care centres (n=5 Catalonia, n=2 Madrid), 2 hospitals (n=1 Catalonia, n=1 Madrid), 2 companies (occupational medicine services; N=1 public, n=1 private). In each facility, doctors, nurses, endocrines and occupational physicians will recruit patients with DT2 who work in offices, remain seated at least 70 % of working hours (OSPAQ) and have a smartphone device. According to CONSORT (2010) criteria, a simple randomisation process led by the research team will assign volunteers to control group (GC) and intervention (GI) using computerised random number generator. It is considered necessary to include 184 patients in each group (n=368 total). The following shall be analysed: basal blood glucose, HbA1c, weight, size, BMI, and waist perimeter. The seat variables (hours of sitting time and number of breaks in seated time) shall be measured using ActivPal device. Other variables: physical activity (short IPAQ), quality of life (EuroQool), work presentism (WLQ), triglycerides, total cholesterol (LDL and HDL), blood pressure and sociodemographic variables. Intervention: Based on an mHealth program (13 weeks) that replaces sedentary work with active. The GC will receive regular advice. A multivariate analysis will study the change in time of dependent variables (post intervention, 6 and 12 months) and establish comparisons between GC and GI. They will be carried out by intent to treat. (English)
12 October 2021
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Barcelona
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Identifiers
PI17_01788
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