CompletedNot Applicable

Effectiveness of a Supervised University-Based Physical Activity and Health Education Program on Lifestyle and Psychological Well-being (Ponte en Forma)

159 participantsStarted 2016-09-01

Plain-language summary

This study evaluates the effectiveness of a structured, supervised university-based program that combines physical activity and health education to promote healthy lifestyle behaviors and psychological well-being. The program, called Ponte en Forma, is implemented at the University of Vigo (Campus of Ourense, Spain) as part of its institutional health promotion strategy. Adult participants (students, university staff, and community members) are allocated either to an intervention group, which takes part in the supervised Ponte en Forma program, or to a control group, which continues their usual unsupervised exercise routine. The intervention lasts four months and includes three weekly supervised exercise sessions plus biweekly counseling focused on healthy eating, prevention of tobacco and alcohol use, and emotional well-being. The main outcomes assessed include body mass index (BMI), blood pressure, resting heart rate, and adherence to the Mediterranean diet. Secondary outcomes include self-esteem, emotional intelligence, health-related quality of life, and lifestyle habits.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Adults aged between 18 and 65 years. Members of the university community (students, academic staff, or administrative personnel) enrolled in the University Sports Service. Willingness to participate in the 4-month supervised physical activity and health education program. Ability to provide written informed consent. Exclusion Criteria: Presence of any medical condition that contraindicates physical exercise (e.g., unstable cardiovascular disease, severe musculoskeletal injury, or uncontrolled hypertension). Current participation in another structured exercise or nutrition program. Pregnancy. Inability to attend at least 75% of scheduled sessions.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Systolic and Diastolic Blood Pressure (SBP and DBP)

Timeframe: Baseline and Month 4

Change in Body Mass Index (BMI)

Timeframe: Baseline and Month 4

Change in Resting Heart Rate (HR)

Timeframe: Baseline and Month 4

Change in Adherence to the Mediterranean Diet (MEDAS-14 score)

Timeframe: Baseline and Month 4

Trial details

NCT IDNCT07268144

SponsorFundacin Biomedica Galicia Sur

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-30

View on ClinicalTrials.gov More Healthy Lifestyle trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Systolic and Diastolic Blood Pressure (SBP and DBP)

Timeframe: Baseline and Month 4

Change in Body Mass Index (BMI)

Timeframe: Baseline and Month 4

Change in Resting Heart Rate (HR)

Timeframe: Baseline and Month 4

Change in Adherence to the Mediterranean Diet (MEDAS-14 score)

Timeframe: Baseline and Month 4