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.
Sponsor: University of Barcelona
Trial Details
| Condition | Non-communicable Diseases (NCD), Cardiovascular Risk, Obesity Prevention |
| Intervention | APA-FIT interdisciplinary program |
| Phase | NA |
| Status | Completed |
| Participants | 520 |
| Est. Completion | 30 Nov 2025 |
| Last Updated | 27 May 2026 |
Primary Outcome
Change from baseline of frecuency and intensity of pysical activity; Change from baseline mediterrainian diet on 14 points on the scale of adherence to the Mediterranean diet.; Change from baseline of positive mental health based on 18 points of the Positive Mental Health Scale-Revised; Change from baseline of the BMI of participants. Weight and height will be combined to report BMI in kg/m^2; Height of participants; Change from baseline of the weight of participants; Change from baseline of water percentage with a bioimpedance scale; Change from baseline of fat mass percentage and kg with a bioimpedance scale; Change from baseline of muscle percentage and kg with a bioimpedance scale; Change from baseline of bone percentage and kg with a bioimpedance scale; Change from baseline of fat free mass percentage and kg with a bioimpedance scale; Change in the baseline of the cardiovascular risk index with the waist-hip measurement; Change in the baseline of food consumption frequency on 30 points of food consumption frequency questionnaire; Number of participants presenting abnormal laboratory results related to lipid profile.; Number of participants presenting abnormal laboratory results related to hormone levels.; Number of participants presenting abnormal laboratory results related to liver function.; Number of participants presenting abnormal laboratory results related to blood glucose level.; Number of participants with abnormal laboratory results related to red and white blood cell series, including monocytes, leukocytes, and hematocrit.
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * \[Not provided; assume standard medical or logistical exclusions will apply.\] Exclusion Criteria Phase II 1. Severe visual or hearing impairments that would preclude participation in the intervention 2. Significant cognitive disorders 3. Dependence in activities of daily living 4. Failure to adhere to the therapeutic commitment and/or provide informed consent 5. Any medical condition that contraindicates physical activity or otherwise prevents completion of the program
Trial Sites
Countries
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