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NCT Number: NCT07268144

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

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.

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Key information

Conditions

Healthy Lifestyle Behavior Cardiovascular Risk Factors Health Promotion Personal Satisfaction Psychological Well-Being Sedentary Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The Ponte en Forma program is a university-based health promotion initiative designed to improve physical, dietary, and psychological health through a combination of supervised exercise and lifestyle counseling. The program is implemented at the University of Vigo (Campus of Ourense, Spain) during the 2016-2017 academic year.

Study Design

This is a quasi-experimental, non-randomized, controlled intervention study. Participants are users of the University Sports Service. The intervention group participates in the supervised Ponte en Forma program, while the control group continues their regular unsupervised exercise activities. Allocation is based on type of enrollment and participant preference.

Intervention Details

The program includes three weekly sessions of supervised physical activity (aerobic, strength, flexibility, and balance training) and biweekly group or individual counseling sessions. Counseling addresses nutrition and the Mediterranean diet, avoidance of tobacco and alcohol consumption, and strategies for emotional well-being.

Outcome Measures

Primary outcomes:

Body Mass Index (BMI)

Systolic and diastolic blood pressure

Resting heart rate

Adherence to the Mediterranean diet (MEDAS-14)

Secondary outcomes:

Physical activity level (IPAQ-SF)

Tobacco and alcohol use

Self-esteem (Rosenberg Self-Esteem Scale)

Emotional intelligence (TMMS-24)

Health-related quality of life (SF-12, EQ-VAS)

Body image perception and risk of disordered eating (SCOFF)

Ethical Considerations

The study was approved by the Galician Clinical Research Ethics Committee (Ref. 2016/567), and all participants provided written informed consent.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ponte en Forma Program

Behavioral

A structured behavioral intervention combining supervised physical training and lifestyle education over a four-month period. The intervention included:

Supervised exercise three times per week, integrating aerobic, strength, flexibility, and balance components adapted to individual fitness levels.

Biweekly counseling sessions on healthy eating, adherence to the Mediterranean diet, prevention of tobacco and alcohol use, and emotional well-being strategies.

Conducted by qualified sports science professionals and health educators. Other Name(s): University-based health promotion program

Primary outcomes

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

    Time frame: Baseline and Month 4

    Mean change in systolic and diastolic blood pressure (mmHg) from baseline to 4 months.

  2. Change in Body Mass Index (BMI)

    Time frame: Baseline and Month 4

    Mean change in participants' body mass index (BMI, kg/m²) from baseline to 4 months, comparing the supervised intervention group and the control group.

  3. Change in Resting Heart Rate (HR)

    Time frame: Baseline and Month 4

    Mean change in resting heart rate (beats per minute) from baseline to 4 months.

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

    Time frame: Baseline and Month 4

    Change in adherence to the Mediterranean diet assessed using the 14-item MEDAS questionnaire.

Sponsors and collaborators

Lead sponsor

Fundacin Biomedica Galicia Sur

Other

Registry information

Official study title

Effectiveness of a Supervised University-Based Physical Activity and Health Education Program on Lifestyle and Psychological Well-being: A Controlled Educational Intervention Study

Acronym: PONTE-FORMA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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