Interdisciplinary Program to Improve the Lifestyle of People With Complex Chronic Pathologies in the Alt Pirineu and Aran Region Using the APA-FIT App: Randomized Controllled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Change from baseline of frecuency and intensity of pysical activity
研究概览
简要总结
Interdisciplinary Program to Improve the Lifestyle of Individuals with Chronic Conditions in the Alt Pirineu and Aran Region
Sedentary behavior and lack of regular physical activity have been widely recognized as urgent global public health issues-not only because they are key risk factors for cardiovascular morbidity and mortality, but also due to their impact on major chronic diseases.
Primary Objective / Hypothesis To evaluate the effectiveness of an intervention program aimed at improving the lifestyle of individuals with chronic conditions in the Alt Pirineu and Aran health region by promoting active living and physical activity (PA), healthy dietary habits, and positive mental health (PMH), through the use of a digital tool (APP). The program also aims to determine whether this intervention leads to a reduction in cardiovascular risk, comorbidity, and premature aging associated with non-communicable diseases.
Study Design and Sample The sample will consist of individuals over 18 years of age with moderate to high cardiovascular risk who voluntarily participate in the project. The program will last for 9 months and will be structured into two groups: an intervention group, which will actively participate in the program through the APP, and a control group, which will not receive the intervention. Pre- and post-intervention measurements will be applied to assess the effects of the program.
Applicability and Relevance This project seeks to implement an interdisciplinary care model for individuals with chronic conditions, aiming to enhance lifestyle behaviors, reduce comorbidity, and mitigate premature aging. The APA-fit digital tool seeks to implement this model by empowering patients in their self-care and facilitating seamless, effective communication between patients and healthcare professionals.
详细描述
Project Justification: Lifestyle, Physical Activity and Public Health
A sedentary lifestyle and lack of regular physical activity have been widely recognised as major global public health concerns. These behaviours are not only significant risk factors for cardiovascular morbidity and mortality, but are also strongly associated with the development and progression of chronic diseases such as cancer, obesity, and type 2 diabetes mellitus. According to the World Health Organization (WHO), physical inactivity accounts for 25% of breast and colon cancer cases, 27% of diabetes cases, and 30% of ischaemic heart disease cases. These figures underscore the urgent need for preventive and therapeutic interventions focused on promoting physical activity and healthy lifestyle habits.
Globally, the prevalence of sedentary behaviour is estimated at 49.7%. A person is considered sedentary if they spend more than five hours seated per day and engage in less than 90 minutes of physical activity per week. Physical activity is defined as any bodily movement produced by skeletal muscles that results in a substantial increase in energy expenditure. This includes everyday activities such as walking, climbing stairs, performing household chores, or shopping. In contrast, exercise refers to planned, structured, and repetitive physical activity aimed at improving or maintaining physical fitness, health, and quality of life. The American College of Sports Medicine (ACSM) recommends that adults engage in moderate-intensity exercise for at least 30 minutes per day, five days per week, or vigorous-intensity exercise for 20 minutes per day, three days per week.
Concurrently, dietary habits have deteriorated, particularly in developed countries, due to accelerated lifestyles, irregular meal patterns, and the widespread availability of ultra-processed foods. These changes have led to increased consumption of products high in sugars, saturated fats, and salt, and a decline in the intake of foods associated with healthy dietary patterns, such as the Mediterranean diet. This diet is characterised by a high intake of fruits, vegetables, legumes, nuts, whole grains, fish, and extra virgin olive oil, and a low intake of red and processed meats. The PREDIMED study has demonstrated that adherence to the Mediterranean diet significantly reduces the risk of cardiovascular events such as acute myocardial infarction and stroke.
The combination of sedentary behaviour and poor dietary habits has contributed to a sustained rise in obesity prevalence, which has become one of the leading public health challenges. The WHO defines obesity as an abnormal or excessive accumulation of body fat that may impair health. It is diagnosed when the body mass index (BMI) is equal to or greater than 30 kg/m². In women, obesity is defined by a body fat percentage exceeding 35%, and in men, 30%. In Spain, the National Health Survey (2015) reported that 53.7% of adults were overweight or obese, and among children and adolescents (aged 2 to 17), the prevalence reached 27.8%. In Catalonia, the 2020 Health Survey indicated that 20% of the adult population was sedentary, rising to 38.1% when minimally active individuals were included. Furthermore, 33.7% of individuals over the age of 15 were overweight, and 17% were obese, with a clear upward trend.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older, diagnosed with one or more chronic conditions
- •Classified as having moderate or high cardiovascular risk for physical activity Moderate Risk: Men ≥ 45 and women ≥ 55 years. Two or more cardiovascular (CV) risk factors High Risk: One or more signs or symptoms of cardiovascular, respiratory, or metabolic disease.Diagnosed cardiovascular or metabolic disease
- •Referred by a primary care physician or community nurse who deems a lifestyle change necessary to improve health and quality of life
- •Ownership of a smartphone with internet access, camera capability, and sufficient internal storage to install and run the APA-FIT app Participants meeting these criteria will be invited to enroll in the study and randomized to either the intervention or control arm for the Phase II evaluation. Continuous monitoring and follow-up will occur throughout the nine-month program and at 3- and 6-month post-intervention checkpoints.
排除标准
- •[Not provided; assume standard medical or logistical exclusions will apply.]
- •Exclusion Criteria Phase II
- •Severe visual or hearing impairments that would preclude participation in the intervention
- •Significant cognitive disorders
- •Dependence in activities of daily living
- •Failure to adhere to the therapeutic commitment and/or provide informed consent
- •Any medical condition that contraindicates physical activity or otherwise prevents completion of the program
研究组 & 干预措施
Control Group (CG) Normal healthcare
- Moderate cardiovascular risk: Standard physical-activity and nutrition counseling
• Assessments: Identical to Branch 1 for nutrition, bioimpedance, PA, and fitness test 2. High cardiovascular risk: Standard physical-activity and nutrition counseling. • Assessments: Identical to Branch 2 for nutrition, bioimpedance, PA, and fitness test
Intervention Group (IG) APP digital tool
- Moderate cardiovascular Risk
. Assessments: Identical to Branch 1 for nutrition, anthropometry/bioimpedance, PA, and fitness
• Risk Monitoring: ECG (if none performed in last six months) and blood tests at the reference primary-care clinic 2. High cardiovascular risk
-
Assessments: Nutritional habits; anthropometry and/or bioimpedance; habitual PA evaluation; fitness testing
-
Risk Monitoring: Fasting blood assays and risk-factor management at participants' primary care clinic
-
Exercise Testing: Maximal exercise tests with gas analysis
-
At Hospital de Cerdanya's Sports Medicine Unit for patients from Puigcerdà and la Seu d'Urgell-Oliana
-
Mobile Sports Medicine teams (portable gas analyzers, laptop, cycle ergometer) for remaining sites
-
All tests supervised by a sports cardiologist
干预措施: APA-FIT interdisciplinary program (Other)
结局指标
主要结局
Change from baseline of frecuency and intensity of pysical activity
时间窗: From enrollment to end of treatment , 9 months
The CLASS-AF (Quick Physical Activity Rating Scale) is a brief tool to estimate habitual physical activity without lengthy questionnaires. It assesses four core items: weekly frequency of moderate/vigorous activity (0-4 pts), average duration per session (0-4 pts), perceived intensity (light = 1, moderate = 2, vigorous = 3 pts), and leisure-time activity level (0-3 pts). Scores are summed (range 0-14) to classify activity: low/sedentary (0-4), moderate (5-9), or high (10-14).
Change from baseline mediterrainian diet on 14 points on the scale of adherence to the Mediterranean diet.
时间窗: from enrollment to end the treatment. 9 months
Description: The scale of adherence to the Mediterranean diet, is a scale based on 14 items where you ask about 7 groups of foods and portions characteristic of this diet. each item must score with a 1 or 0 depending on the fulfilled or not. The sum of the points if it is less than 9 indicates a bad grip if it is equal to or greater than 9 , a good grip
Change from baseline of positive mental health based on 18 points of the Positive Mental Health Scale-Revised
时间窗: From enrollment to end the treatment. 9 months
Change from baseline of positive mental health based on 18 points of the Positive Mental Health Scale-Revised Description: The SMP multifactorial scale revised, consists of 18 items that are distributed among 6 factors: Personal Satisfaction, Prosocial Attitude, Self-Control, Autonomy, Problem Solving and Self-Update, and Interpersonal Relationship Skills. The evaluation of each item is done with a scale scale ranging from 1 to 4. Being 1, always or almost always, 2, quite often, 3 often and 4, never or almost never. Finally, a score between 18 and 72 is obtained, the higher the score the more positive mental health.
Change from baseline of the BMI of participants. Weight and height will be combined to report BMI in kg/m^2
时间窗: From enrollment to end of treatment, 9 months
The formula (weight/height m²) will be applied to measure Body Mass Index (BMI).
Height of participants
时间窗: baseline
The height will be measured with a measuring tape in meters. Participants will be measured without shoes.
Change from baseline of the weight of participants
时间窗: From enrollment to end of treatment, 9 months
Weigh will be mesured with a analogic weighing machine in Kilograms. Participants are mesured only with underwear clouths
Change from baseline of water percentage with a bioimpedance scale
时间窗: From enrollment and each 3 month (3, 6, 9)
Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602
Change from baseline of fat mass percentage and kg with a bioimpedance scale
时间窗: From enrollment and each 3 month (3, 6, 9)
Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602
Change from baseline of muscle percentage and kg with a bioimpedance scale
时间窗: From enrollment and each 3 month (3, 6, 9)
Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602
Number of participants with abnormal laboratory results related to red and white blood cell series, including monocytes, leukocytes, and hematocrit.
时间窗: From enrollment to end of treatment, 9 months
Monocytes and leukocytes will be measured in ×10³/μL, and hematocrit will be expressed as a percentage.
Change from baseline of bone percentage and kg with a bioimpedance scale
时间窗: From enrollment and each 3 month (3, 6, 9)
Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602
Change from baseline of fat free mass percentage and kg with a bioimpedance scale
时间窗: From enrollment and each 3 month (3, 6, 9)
Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602
Change in the baseline of the cardiovascular risk index with the waist-hip measurement
时间窗: From enrollment to end of treatment, 9 months
The waist-to-hip ratio (WHR) is used to estimate intra-abdominal fat and assess cardiovascular risk. It's calculated by dividing waist circumference by hip circumference (in centimetres). According to WHO, a WHR ≤ 0.80 in women and ≤ 0.95 in men indicates low risk. Moderate risk is defined as 0.81-0.85 in women and 0.96-1.00 in men. Values ≥ 0.86 in women and ≥ 1.01 in men suggest high cardiovascular risk.
Change in the baseline of food consumption frequency on 30 points of food consumption frequency questionnaire
时间窗: From enrollment to end of treatment, 9 months
The following questionnaire is to be completed by the subject in order to ascertain their habitual dietary intake. The questionnaire under consideration consists of 30 items, which have been classified into the following food groups: carbohydrates, proteins, fats, sugars, dairy products and legumes. For each item, respondents are required to indicate whether the food or drink is consumed daily, weekly, monthly, annually, or never.
Number of participants presenting abnormal laboratory results related to lipid profile.
时间窗: From enrollment to end of treatment, 9 months
In relation to the lipid profile, the following are assessed: total cholesterol, LDL, HDL and triglyceride levels mesured in mg/dL of blood.
Number of participants presenting abnormal laboratory results related to hormone levels.
时间窗: From enrollment to end of treatment, 9 months
Hormonal profile assessment includes TSH (mesured in IU/ml) and cortisol (mesured in mg/dl)
Number of participants presenting abnormal laboratory results related to liver function.
时间窗: From enrollment to end of treatment, 9 months
The hepatic profile is assessed by measuring creatinine and urea in mg/dl.
Number of participants presenting abnormal laboratory results related to blood glucose level.
时间窗: From enrollment to end of treatment, 9 months
Glucose and glycosylated haemoglobin (only in diabetic individuals) are measured in mg/dL.
次要结局
未报告次要终点
研究者
Marta Prats Arimon
Principal Investigator
University of Barcelona