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Web-based Exercise for South Asian People With Type 2 Diabetes

20 de noviembre de 2018 actualizado por: NHS Greater Glasgow and Clyde

Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial

This randomised controlled trial aims to investigate the effect of a 12 week personalised exercise programme delivered using a web-based platform, compared to usual care, on glycaemic control, muscle strength, functional ability, blood lipid profile, blood pressure and quality of life in adult South Asians with Type 2 Diabetes Mellitus

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

A mixed method approach involving both qualitative and quantitative methods will be used.

The quantitative component will consist of a single blind, randomised controlled trial (RCT), which will explore the effects of the intervention on glycaemic control (blood sugar levels) and other secondary outcomes.

The qualitative component will consist of face to face interviews to explore the views of participants regarding acceptability and barriers affecting adherence to this intervention.

Potential participants will be informed about the study at hospital diabetes clinics, community health organisations, support groups, places of worship and General Practitioner (GP) surgeries. Recruitment is estimated to last for 9 months. Potential participants will be sent a participant information sheet (PIS) in either English or Urdu, depending on their preference. Those wishing to take part will meet the researcher at a convenient location, for eligibility screening and consent. If necessary, translation services can be arranged for those with limited English throughout the study.

Following baseline assessment, participants will be randomised to either the intervention or control group. Participants in the control group will be asked to continue their usual care and day to day physical activity routine. In addition, they will be given general information about diabetes management. Participants who wish to use the website for exercise will be provided with access at the end of all assessments.

Participants assigned to the intervention group will be asked to perform a personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks. Participants will meet the researcher face to face immediately after randomisation. During this meeting, a brief physical assessment will be undertaken and exercise goals will be discussed and agreed with participants. The researcher will then design a personalised exercise programme for each participant using the resources available on the web-based exercise website. The exercise programme prescription and progression will be in line with American Diabetes Association (ADA) and American College of Sports Medicine (ACSM) guidelines (Colberg et al. 2016). The website (www.webbasedphysio.com) will be used to deliver the intervention. This website has been modified, in collaboration with South Asians, to be culturally suitable for people of South Asian backgrounds in terms of content and language (Albalawi et al, under review). The researcher will contact participants every two weeks via telephone to encourage use of the website, ask about progress, and to deal with any technical issues that they might face while using the website. Participants will be advised to contact the researcher to request a change in their programme or if a problem arises. The researcher will make changes remotely and participants will be informed of any changes by phone or email. Participants will be asked to meet the researcher face to face to discuss progression and goals at week 6 (midway). Regardless of groups allocation, all participants will be assessed three times by a blind assessor at baseline (week=0) , after the end of the intervention (week=12) and 8 weeks after the end of the intervention (week=20).

Assessment of outcome measures will take place at convenient locations and each visit should take no more than 90 minutes. Travel expenses will be provided.

All participants will be informed that they are free to withdraw from the study at any time without being obliged to give notice or provide any explanation. Any data collected before their withdrawal will be considered in the analysis.

Tipo de estudio

Intervencionista

Inscripción (Actual)

33

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

  • Reino Unido
      • Glasgow, Reino Unido
        • NHS Greater Glasgow and Clyde

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

25 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • define themselves as South Asians
  • BMI 21 - 29.9 kg/m2
  • diagnosed with Type 2 Diabetes Mellitus (T2DM) by a physician more than 6 months previously
  • access to a personal computer/tablet, smart phone or smart television with an email address and Internet connection
  • able to understand English or Urdu

Exclusion Criteria:

  • type 1 diabetes
  • any medical conditions that would affect adherence or contraindicate exercise including severe peripheral neuropathy, severe autonomic neuropathy, severe physical limitations, heart disease, pre-proliferative or proliferative retinopathy, uncontrolled hypertension (>180/ 100mmHg), or coronary artery disease.
  • people using insulin if they do not have a self-monitoring glucose device or are unable to use such devices.
  • engaging in exercise training of 150 minutes a week or more
  • participating in other interventional studies aiming to improve glycaemic control
  • unwilling to be randomised

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

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Grupo de control
Cuidado usual
Experimental: Web-based exercise programme
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
Conductual: Web-based exercise programme
Aerobic, resistance and balance exercises

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Glycaemic control
Periodo de tiempo: Baseline to 12 weeks
Change in HbA1c
Baseline to 12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood lipid profile (cholesterol)
Periodo de tiempo: Baseline to 12 weeks
Change in total cholesterol level
Baseline to 12 weeks
Blood lipid profile (cholesterol)
Periodo de tiempo: 12 weeks to 20 weeks
Change in total cholesterol level
12 weeks to 20 weeks
Blood lipid profile (high density lipoproteins)
Periodo de tiempo: Baseline to 12 weeks
Change in high density lipoprotein (HDL) level
Baseline to 12 weeks
Blood lipid profile (high density lipoproteins)
Periodo de tiempo: 12 weeks to 20 weeks
Change in high density lipoprotein (HDL) level
12 weeks to 20 weeks
Blood lipid profile (low-density lipoproteins)
Periodo de tiempo: Baseline to 12 weeks
Change in low density lipoprotein (LDL) level
Baseline to 12 weeks
Blood lipid profile (low-density lipoproteins)
Periodo de tiempo: 12 weeks to 20 weeks
Change in low density lipoprotein (LDL) level
12 weeks to 20 weeks
Blood lipid profile (triglyceride)
Periodo de tiempo: Baseline to 12 weeks
Change in triglyceride level
Baseline to 12 weeks
Blood lipid profile (triglyceride)
Periodo de tiempo: 12 weeks to 20 weeks
Change in triglyceride level
12 weeks to 20 weeks
Blood pressure
Periodo de tiempo: Baseline to 12 weeks
Change in blood pressure result
Baseline to 12 weeks
Blood pressure
Periodo de tiempo: 12 weeks to 20 weeks
Change in blood pressure result
12 weeks to 20 weeks
Body mass index (BMI)
Periodo de tiempo: Baseline to 12 weeks
Change in BMI
Baseline to 12 weeks
Body mass index (BMI)
Periodo de tiempo: 12 weeks to 20 weeks
Change in BMI
12 weeks to 20 weeks
Waist circumference
Periodo de tiempo: Baseline to 12 weeks
Change in waist circumference
Baseline to 12 weeks
Waist circumference
Periodo de tiempo: 12 weeks to 20 weeks
Change in waist circumference
12 weeks to 20 weeks
Ten metre walking test (10MWT)
Periodo de tiempo: Baseline to 12 weeks
Change in 10 MWT result
Baseline to 12 weeks
Ten metre walking test (10MWT)
Periodo de tiempo: 12 weeks to 20 weeks
Change in 10 MWT result
12 weeks to 20 weeks
Timed Up and Go test
Periodo de tiempo: Baseline to 12 weeks
Change in Timed Up and Go test result
Baseline to 12 weeks
Timed Up and Go test
Periodo de tiempo: 12 weeks to 20 weeks
Change in Timed Up and Go test result
12 weeks to 20 weeks
Muscle power
Periodo de tiempo: Baseline to 12 weeks
Change in hand grip dynamometer score
Baseline to 12 weeks
Muscle power
Periodo de tiempo: 12 weeks to 20 weeks
Change in hand grip dynamometer score
12 weeks to 20 weeks
Quality of Life - WHO-QOL BREF score
Periodo de tiempo: Baseline to 12 weeks
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
Baseline to 12 weeks
Quality of Life - WHO-QOL BREF score
Periodo de tiempo: 12 weeks to 20 weeks
Change in World Health Organisation Quality of Life (WHO-QOL BREF) score
12 weeks to 20 weeks
Adherence - exercise diary completion
Periodo de tiempo: 12 weeks
Number of times exercise diary completed
12 weeks
Dietary intake
Periodo de tiempo: Baseline to 12 weeks
Change in Food Frequency Questionnaire score
Baseline to 12 weeks
Dietary intake
Periodo de tiempo: 12 weeks to 20 weeks
Change in Food Frequency Questionnaire score
12 weeks to 20 weeks
Change in Medication
Periodo de tiempo: Baseline to 12 weeks
Change in medication
Baseline to 12 weeks
Change in Medication
Periodo de tiempo: 12 weeks to 20 weeks
Change in medication
12 weeks to 20 weeks
Glycaemic control
Periodo de tiempo: 12 weeks to 20 weeks
Change in HbA1c
12 weeks to 20 weeks

Colaboradores e Investigadores

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

Patrocinador

NHS Greater Glasgow and Clyde

Colaboradores

University of Glasgow

Investigadores

  • Director de estudio: Lorna Paul, PhD, Glasgow Caledonian University

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)

6 de noviembre de 2017

Finalización primaria (Actual)

22 de agosto de 2018

Finalización del estudio (Actual)

22 de agosto de 2018

Fechas de registro del estudio

Enviado por primera vez

27 de junio de 2017

Primero enviado que cumplió con los criterios de control de calidad

27 de junio de 2017

Publicado por primera vez (Actual)

29 de junio de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de noviembre de 2018

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

20 de noviembre de 2018

Última verificación

1 de noviembre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GN17DI329

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. .

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