Web-based Exercise for South Asian People With Type 2 Diabetes
Web-based Exercise Intervention for South Asian People With Type 2 Diabetes: a Randomised Controlled Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Glasgow, Соединенное Королевство
- NHS Greater Glasgow and Clyde
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Контрольная группа
Обычный уход
|
|
|
Экспериментальный: Web-based exercise programme
Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks
|
Aerobic, resistance and balance exercises
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Glycaemic control
Временное ограничение: Baseline to 12 weeks
|
Change in HbA1c
|
Baseline to 12 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Blood lipid profile (cholesterol)
Временное ограничение: Baseline to 12 weeks
|
Change in total cholesterol level
|
Baseline to 12 weeks
|
|
Blood lipid profile (cholesterol)
Временное ограничение: 12 weeks to 20 weeks
|
Change in total cholesterol level
|
12 weeks to 20 weeks
|
|
Blood lipid profile (high density lipoproteins)
Временное ограничение: Baseline to 12 weeks
|
Change in high density lipoprotein (HDL) level
|
Baseline to 12 weeks
|
|
Blood lipid profile (high density lipoproteins)
Временное ограничение: 12 weeks to 20 weeks
|
Change in high density lipoprotein (HDL) level
|
12 weeks to 20 weeks
|
|
Blood lipid profile (low-density lipoproteins)
Временное ограничение: Baseline to 12 weeks
|
Change in low density lipoprotein (LDL) level
|
Baseline to 12 weeks
|
|
Blood lipid profile (low-density lipoproteins)
Временное ограничение: 12 weeks to 20 weeks
|
Change in low density lipoprotein (LDL) level
|
12 weeks to 20 weeks
|
|
Blood lipid profile (triglyceride)
Временное ограничение: Baseline to 12 weeks
|
Change in triglyceride level
|
Baseline to 12 weeks
|
|
Blood lipid profile (triglyceride)
Временное ограничение: 12 weeks to 20 weeks
|
Change in triglyceride level
|
12 weeks to 20 weeks
|
|
Blood pressure
Временное ограничение: Baseline to 12 weeks
|
Change in blood pressure result
|
Baseline to 12 weeks
|
|
Blood pressure
Временное ограничение: 12 weeks to 20 weeks
|
Change in blood pressure result
|
12 weeks to 20 weeks
|
|
Body mass index (BMI)
Временное ограничение: Baseline to 12 weeks
|
Change in BMI
|
Baseline to 12 weeks
|
|
Body mass index (BMI)
Временное ограничение: 12 weeks to 20 weeks
|
Change in BMI
|
12 weeks to 20 weeks
|
|
Waist circumference
Временное ограничение: Baseline to 12 weeks
|
Change in waist circumference
|
Baseline to 12 weeks
|
|
Waist circumference
Временное ограничение: 12 weeks to 20 weeks
|
Change in waist circumference
|
12 weeks to 20 weeks
|
|
Ten metre walking test (10MWT)
Временное ограничение: Baseline to 12 weeks
|
Change in 10 MWT result
|
Baseline to 12 weeks
|
|
Ten metre walking test (10MWT)
Временное ограничение: 12 weeks to 20 weeks
|
Change in 10 MWT result
|
12 weeks to 20 weeks
|
|
Timed Up and Go test
Временное ограничение: Baseline to 12 weeks
|
Change in Timed Up and Go test result
|
Baseline to 12 weeks
|
|
Timed Up and Go test
Временное ограничение: 12 weeks to 20 weeks
|
Change in Timed Up and Go test result
|
12 weeks to 20 weeks
|
|
Muscle power
Временное ограничение: Baseline to 12 weeks
|
Change in hand grip dynamometer score
|
Baseline to 12 weeks
|
|
Muscle power
Временное ограничение: 12 weeks to 20 weeks
|
Change in hand grip dynamometer score
|
12 weeks to 20 weeks
|
|
Quality of Life - WHO-QOL BREF score
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 12 weeks
|
Number of times exercise diary completed
|
12 weeks
|
|
Dietary intake
Временное ограничение: Baseline to 12 weeks
|
Change in Food Frequency Questionnaire score
|
Baseline to 12 weeks
|
|
Dietary intake
Временное ограничение: 12 weeks to 20 weeks
|
Change in Food Frequency Questionnaire score
|
12 weeks to 20 weeks
|
|
Change in Medication
Временное ограничение: Baseline to 12 weeks
|
Change in medication
|
Baseline to 12 weeks
|
|
Change in Medication
Временное ограничение: 12 weeks to 20 weeks
|
Change in medication
|
12 weeks to 20 weeks
|
|
Glycaemic control
Временное ограничение: 12 weeks to 20 weeks
|
Change in HbA1c
|
12 weeks to 20 weeks
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Директор по исследованиям: Lorna Paul, PhD, Glasgow Caledonian University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- GN17DI329
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Сахарный диабет, тип 2
-
Fondazione Policlinico Universitario Agostino Gemelli...Еще не набираютОжирение | Диабет 2 типа | Инсулинорезистентный диабет (Mellitus)