Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT04058093
Brief Summary:
Sedentarism is the fourth risk factor for worldwide mortality and morbility. Considering the high prevalence of sedentarism (57.0%) and obesity (30.5%) in Azores islands (Portugal), local primary health care (PHC) services should support the implementation of complementary interventions and the development of medical research in the area of active lifestyle promotion.
This study aims to evaluate the feasibility and effectiveness of a 6-months functional training program (FTP), which includes a group nutrition counseling, in sedentary users of Ponta Delgada Health Center (PDHC), compared to a waiting list control.
Detailed Description:
This work will be a prospective, longitudinal, quasi-experimental study, with an experimental and a waiting list control group. Here, the investigators aim to test the feasibility and effectiveness of a 6-months functional training program in sedentary users of PDHC. The recruitment of participants will be held in PDHC by health professionals (e.g., family medicine doctors, nurses, nutritionists, psychologists, etc). Participants will be allocated into two groups (experimental and waiting list control groups). After signed informed consent and baseline measures, experimental group will conduct a 6-months functional training program (FTP), which comprises functional training sessions and group nutrition counseling. In every session, it will be evaluated the participants' adherence and theirs perceived enjoyment and exertion. The other outcomes (primary and secondary) will be analyzed through a face-to-face contact, in three different moments: baseline (T0), post-intervention (at month 6, T1) and 6-month follow-up (at month 12, T2). The control group will not participate in any specific intervention, but will receive the FTP after the experimental period. An intention-to-treat and per protocol analysis will be performed to analyze intervention effectiveness and efficacy.
Study:
NCT04058093
Study Brief:
Protocol Section:
NCT04058093