A Socio-ecological Approach to Reduce the Physical Activity Drop-out Ratio in Primary Care-based Patients With Type 2 Diabetes: The SENWI Study Protocol for a Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 10
- 主要终点
- Participant physical activity levels
研究概览
简要总结
Physical activity (PA) - understood as any bodily movement produced by skeletal muscular that requires energy expenditure, related to leisure time, for transport to get to and from places, or part of a person's work - is a powerful force for good regarding type 2 diabetes mellitus (T2DM). However, fewer T2DM patients sustain the lifestyle recommendations suggested by health care professionals (HCP): 40% of patients did not follow-up on general medical recommendations regarding lifestyle changes. Using a socio-ecological approach - that aims to deal with the different levels of PA influences - may be a good solution to integrate the behaviour change techniques in health care professionals' consultations to prescribe PA efficiently.
The investigators' protocol has two aims. The primary aim is to evaluate the effectiveness of theory-driven PA intervention based on SEM among people living with T2DM. A secondary aim is to explore the feasibility and perceptions/experiences on the PA adherence process in T2DM patients while using the socio-ecological approach and to understand the HCP's viewpoint in its applicability in the Spanish Healthcare system. The investigators want to know the how, not the what, related to PA prescription.
详细描述
Physical activity (PA) - understood as any bodily movement produced by skeletal muscles that require energy expenditure, related to leisure time, for transport to get to and from places, or part of a person's work - is a powerful force for good regarding type 2 diabetes mellitus (T2DM). A recent meta-analysis has confirmed a positive dose-response relationship between markers of glucose control and increasing daily PA (a 20% increase in adherence or two sessions/month was associated with a 0.15% - 2 mmol/mol - decrease in HbA1c). Adhering to regular PA - understood as not dropping out the new PA behaviour adopted - is a way to control T2DM and promote people living with T2DM self-management. Still, fewer T2DM patients sustain the lifestyle recommendations suggested by health care professionals (HCP): 40% of patients did not follow up on general medical recommendations regarding lifestyle changes.
Socioeconomic status and health or social inequity, immediate and non-negotiable patients' needs and adherence skills rarely discussed by HCP, urban planning and political decisions about PA, or physical inactive workplaces may be reasons for these poor results in sustaining PA lifestyle recommendations.
Researchers have proposed aerobic or resistance exercise - understood as PA planned, structured, and realized during the leisure-time - like Nordic walking, high-intensity training, or lifting weights to increase PA levels throughout exercise among T2DM patients. Despite all options having good results in metabolic and patients' health outcomes, it seems that they are only used in well-controlled studies rather than in healthcare: that may be due to the HCP difficulty and lack of time, support, and knowledge to prescribe this type of aerobic and resistance exercise.
As a result, HCP most common prescription is based on walking, as it is easy to recommend and to do it by people living with T2DM without contraindications. However, only doing that recommendation will be not efficient nor effective to improve PA levels among people living with T2DM. For example, the more prevalent of people living with T2DM belongs to the lower-medium class, which usually live in neighborhoods with poor walkability and parks or green spaces. As a result, patients used to drop out in the long run and despite decades of this type of recommendation, PA population levels are still a problem to be faced. With that panorama, HCP may intentionally withdraw from PA prescriptions to protect patients who find it difficult to keep going.
In this context, ineffective primary-care-based PA prescription risks missing out on the health benefits of the powerful factors that manage people living with T2DM health-related outcomes. Moreover, ineffective primary-care-based PA prescription may enhance socioeconomic barriers and health inequity in these patients. Therefore, given the scale and span of these PA biological and social benefits, it remains a Public Health priority to deploy more effective ways to implement day-to-day PA life. Doing so will be helpful for health patients and for both HCP that used to have not enough time to prescribe exercise effectivity and Public Health expenses in T2DM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The trial has an open design with a blind assessment of outcomes. Researchers conduction the baseline assessments will be blind to group allocation. The statistician (RMV) will also be blind to group allocation until the completion of the statistical analysis. Participants will be asked not to reveal group allocation when undergoing follow-up measurements. To assess the extent to which blinding has been preserved, researchers will record the number of cases in which allocation was revealed.
入排标准
- 年龄范围
- 45 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2D
- •Be eligible to be referred by their doctors for PA intervention;
- •Have no major physical limitations prescribed by the doctor or any HCP
- •Physical inactive according to the General Practice Physical Activity Questionnaire - GPPAQ screening tool.
排除标准
- •Pregnant patients or have T2D due to gestation
- •Inability to freely consent to take part in the study
- •Inability to understand the study materials or PA intervention
- •T2D patients with complications as neuropathy, retinopathy, and nephropathy
- •Contraindications to do PA
- •Body Mass Index over 34,9
结局指标
主要结局
Participant physical activity levels
时间窗: 2 years
PA levels will be assessed throughout activPAL3™ micro
Participant physical activity drop-out ratio
时间窗: up to 12 weeks
During the intervention, drop out will be considered as less than 80% of assistance at schedule sessions. After the intervention, PA drop out will be measured asking the participants if they continue to undertake PA in their daily life. Participants will be asked once a month until the 24-month (21-month post-intervention) throughout telephone calls and messages (using ecological memorial assessments) about the following-up. What will be important if they do any kind of PA, no matter what kind. The answer will be registered as yes or no.
Metabolic participants outcomes
时间窗: 2 years
HbA1c analysis from blood sample
次要结局
- Socioeconomic participant status(Before the intervention)
