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

December 3, 2025 updated by: Fundacin Biomedica Galicia Sur

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm - Ponte en Forma Program
Participants in this group took part in the "Ponte en Forma" supervised physical activity and health education program conducted at the University of Vigo (Campus of Ourense). The program lasted four months and combined supervised exercise sessions three times per week with biweekly group or individual counseling on nutrition, tobacco and alcohol prevention, and emotional well-being. Attendance of at least 75% of sessions was considered adherent.

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

No Intervention: Control Arm - Usual Unsupervised Activity
Participants in the control group continued their usual unsupervised physical activity at the university sports facilities. They received only a written leaflet summarizing general recommendations on healthy diet, regular exercise, and avoidance of tobacco and alcohol, with no individualized supervision or follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 4
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.
Baseline and Month 4
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.
Baseline and Month 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.
Baseline and Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the dataset contains personal health and academic information collected under institutional confidentiality agreements. De-identified summary data supporting the findings are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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