Interdisciplinary Program to Improve Lifestyle in Chronic Pathology: Alt Pirineu Aran in Fit (APA-FIT)

NCT07172490 | Completed

• 1 other identifier: IDIAP JORDI GOL 24/163-ACps
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-communicable Diseases (NCD); Cardiovascular Risk; Obesity Prevention

Keywords

Physical Activity; Nutrition; Mental Health; Digital Tools

Outcome Measures

Primary Outcomes (18)

• Change from baseline of frecuency and intensity of pysical activity

  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).

  From enrollment to end of treatment , 9 months

• Change from baseline mediterrainian diet on 14 points on the scale of adherence to the Mediterranean diet.

  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

  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

  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.

  From enrollment to end the treatment. 9 months

• Change from baseline of the BMI of participants. Weight and height will be combined to report BMI in kg/m^2

  The formula (weight/height m²) will be applied to measure Body Mass Index (BMI).

  From enrollment to end of treatment, 9 months

• Height of participants

  The height will be measured with a measuring tape in meters. Participants will be measured without shoes.

  baseline

• Change from baseline of the weight of participants

  Weigh will be mesured with a analogic weighing machine in Kilograms. Participants are mesured only with underwear clouths

  From enrollment to end of treatment, 9 months

• Change from baseline of water percentage with a bioimpedance scale

  Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602

  From enrollment and each 3 month (3, 6, 9)

• Change from baseline of fat mass percentage and kg with a bioimpedance scale

  Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602

  From enrollment and each 3 month (3, 6, 9)

• Change from baseline of muscle percentage and kg with a bioimpedance scale

  Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602

  From enrollment and each 3 month (3, 6, 9)

• Change from baseline of bone percentage and kg with a bioimpedance scale

  Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602

  From enrollment and each 3 month (3, 6, 9)

• Change from baseline of fat free mass percentage and kg with a bioimpedance scale

  Participants are measured only with underwear cloths on the bioimpedance scale TANITA BC 602

  From enrollment and each 3 month (3, 6, 9)

• Change in the baseline of the cardiovascular risk index with the waist-hip measurement

  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.

  From enrollment to end of treatment, 9 months

• Change in the baseline of food consumption frequency on 30 points of food consumption frequency questionnaire

  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.

  From enrollment to end of treatment, 9 months

• Number of participants presenting abnormal laboratory results related to lipid profile.

  In relation to the lipid profile, the following are assessed: total cholesterol, LDL, HDL and triglyceride levels mesured in mg/dL of blood.

  From enrollment to end of treatment, 9 months

• Number of participants presenting abnormal laboratory results related to hormone levels.

  Hormonal profile assessment includes TSH (mesured in IU/ml) and cortisol (mesured in mg/dl)

  From enrollment to end of treatment, 9 months

• Number of participants presenting abnormal laboratory results related to liver function.

  The hepatic profile is assessed by measuring creatinine and urea in mg/dl.

  From enrollment to end of treatment, 9 months

• Number of participants presenting abnormal laboratory results related to blood glucose level.

  Glucose and glycosylated haemoglobin (only in diabetic individuals) are measured in mg/dL.

  From enrollment to end of treatment, 9 months

• Number of participants with abnormal laboratory results related to red and white blood cell series, including monocytes, leukocytes, and hematocrit.

  Monocytes and leukocytes will be measured in ×10³/μL, and hematocrit will be expressed as a percentage.

  From enrollment to end of treatment, 9 months

Study Arms (2)

Control Group (CG) Normal healthcare

NO INTERVENTION

1. 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

EXPERIMENTAL

1. 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

Other: APA-FIT interdisciplinary program

Interventions

APA-FIT interdisciplinary program OTHER

Intervention: APA-FIT The APA-FIT program is an interdisciplinary intervention targeting three core domains in adults with chronic conditions at moderate or high risk for physical activity (PA): physical exercise, nutritional habits, and positive mental health. Over nine months, participants receive: * Individualized PA Prescription * Bimonthly follow-up visits with a certified PA prescriber (physician, nurse, or physiotherapist) * Weekly supervised exercise sessions led by a coach * Automated PA logging and goal tracking via the APA-FIT app * Nutritional Counseling * Initial and final dietary assessments with a registered nutritionist * Bimonthly follow-up and three hands-on Mediterranean-diet workshops * Psychosocial Support for Positive Mental Health * Four bimonthly group sessions facilitated by the primary-care emotional-well-being lead * In-app materials, peer support features, and one-on-one check-ins

Intervention Group (IG) APP digital tool

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Barcelona: lead
• CatSalut Catalonia, Spain: collaborator

Study Sites (1)

Agrupació Europea de Cooperació Territorial

Puigcerdà, Girona, 17520, Spain

Location

Related Publications (15)

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• Màs-Alòs, S., Galindo-Ortego, G., Panas-Anzano, A., Peirau-Terés, X., Real, J.(2017).Promoció de la salut i prescripció d'exercici físic des de centres d'atenció primària. Justificació i disseny. Apunts. Educació Física i Esports, 3, 40-57.

  BACKGROUND

• WHO. (2015). Physical activity strategy forthe WHO European Region 2016-2025. Physical activity strategy forthe WHO European Region 2016-2025. Regional Committee for Europe 65th session (págs. 5-27). Vilnius, Lithuania: World Health Organization.

  BACKGROUND

• WHO. (2013). Global action plan for the prevention and control of noncommunicable diseases 2013-2020.Geneva: World Health Organization. Obtenido de World Health Organization: (http://www.who.int/nmh/publications/ncd-action-plan/en/)

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  PMID: 30193830 BACKGROUND

• Lopez-Valenciano A, Mayo X, Liguori G, Copeland RJ, Lamb M, Jimenez A. Changes in sedentary behaviour in European Union adults between 2002 and 2017. BMC Public Health. 2020 Aug 26;20(1):1206. doi: 10.1186/s12889-020-09293-1.

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• Budreviciute A, Damiati S, Sabir DK, Onder K, Schuller-Goetzburg P, Plakys G, Katileviciute A, Khoja S, Kodzius R. Management and Prevention Strategies for Non-communicable Diseases (NCDs) and Their Risk Factors. Front Public Health. 2020 Nov 26;8:574111. doi: 10.3389/fpubh.2020.574111. eCollection 2020.

  PMID: 33324597 BACKGROUND

• Celis-Morales CA, Lyall DM, Anderson J, Iliodromiti S, Fan Y, Ntuk UE, Mackay DF, Pell JP, Sattar N, Gill JM. The association between physical activity and risk of mortality is modulated by grip strength and cardiorespiratory fitness: evidence from 498 135 UK-Biobank participants. Eur Heart J. 2017 Jan 7;38(2):116-122. doi: 10.1093/eurheartj/ehw249.

  PMID: 28158566 BACKGROUND

• Ministerio de Sanidad Consumo y Bienestar. Encuesta Nacional de Salud España 2017. Resumen Metodológico. Encuesta Nac Salud España 2017 Resum Metod. 2017; [aprox. 3 p.]. Available online: https://www.sanidad.gob.es/estadEstudios/estadisticas/ encuestaNacional/encuesta2017.htm

  BACKGROUND

• Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.

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• Zubin Maslov P, Schulman A, Lavie CJ, Narula J. Personalized exercise dose prescription. Eur Heart J. 2018 Jul 1;39(25):2346-2355. doi: 10.1093/eurheartj/ehx686.

  PMID: 29301027 BACKGROUND

• Liu Y, Yan T, Chu JM, Chen Y, Dunnett S, Ho YS, Wong GT, Chang RC. The beneficial effects of physical exercise in the brain and related pathophysiological mechanisms in neurodegenerative diseases. Lab Invest. 2019 Jul;99(7):943-957. doi: 10.1038/s41374-019-0232-y. Epub 2019 Feb 26.

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• Poon ET, Little JP, Sit CH, Wong SH. The effect of low-volume high-intensity interval training on cardiometabolic health and psychological responses in overweight/obese middle-aged men. J Sports Sci. 2020 Sep;38(17):1997-2004. doi: 10.1080/02640414.2020.1766178. Epub 2020 Jun 4.

  PMID: 32497454 BACKGROUND

• Prats-Arimon M, Puig-Llobet M, Barcelo-Peiro O, Ribot-Domenech I, Vilalta-Sererols C, Fontecha-Valero B, Heras-Ojeda M, Aguera Z, Lluch-Canut T, Moreno-Poyato A, Moreno-Arroyo MC. An Interdisciplinary Intervention Based on Prescription of Physical Activity, Diet, and Positive Mental Health to Promote Healthy Lifestyle in Patients with Obesity: A Randomized Control Trial. Nutrients. 2024 Aug 20;16(16):2776. doi: 10.3390/nu16162776.

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• Brorsson Lundqvist E, Praetorius Bjork M, Bernhardsson S. Physical activity on prescription in Swedish primary care: a survey on use, views, and implementation determinants amongst general practitioners. Scand J Prim Health Care. 2024 Mar;42(1):61-71. doi: 10.1080/02813432.2023.2288126. Epub 2024 Feb 7.

  PMID: 38047631 BACKGROUND

MeSH Terms

Conditions

Noncommunicable Diseases; Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction

Study Officials

• Marta Prats-Arimon, PHD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A multicenter, quasi-experimental pre-post study with two parallel arms-intervention group (IG) and control group (CG).

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 15, 2025
• Study Start: September 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 9, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From juin 2025 until the article will be published
• Access Criteria: All team researchers from University of Barcelona and Hospital de Cerdanya can share IPD throught SPSS program by corporative mail.All researchers need a password to access the institution's intranet. In addition, a shared folder will be generated where only researchers have access to share other documents

Locations

ES (1)