NCT07268144

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

November 20, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

University health promotionPhysical activity interventionMediterranean diet adherenceLifestyle behavior changePsychological well-beingSelf-esteemEmotional intelligenceNon-communicable diseases preventionYoung adultsControlled educational intervention

Outcome Measures

Primary Outcomes (4)

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

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

    Baseline and Month 4

  • Change in Body Mass Index (BMI)

    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)

    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)

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

    Baseline and Month 4

Study Arms (2)

Intervention Arm - Ponte en Forma Program

EXPERIMENTAL

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.

Behavioral: Ponte en Forma Program

Control Arm - Usual Unsupervised Activity

NO INTERVENTION

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.

Interventions

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

Intervention Arm - Ponte en Forma Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PMID: 8628042BACKGROUND
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694BACKGROUND
  • Salovey P, Mayer JD, Goldman SL, Turvey C, Palfai TP. Emotional attention, clarity, and repair: exploring emotional intelligence using the Trait Meta-Mood Scale. In: Pennebaker JW, editor. Emotion, disclosure, and health. Washington, DC: American Psychological Association; 1995. p. 125-54.

    BACKGROUND
  • Schroder H, Fito M, Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Lamuela-Raventos R, Ros E, Salaverria I, Fiol M, Lapetra J, Vinyoles E, Gomez-Gracia E, Lahoz C, Serra-Majem L, Pinto X, Ruiz-Gutierrez V, Covas MI. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 Jun;141(6):1140-5. doi: 10.3945/jn.110.135566. Epub 2011 Apr 20.

    PMID: 21508208BACKGROUND
  • Sánchez A, et al. Adherence to the Mediterranean diet in a university population: factors associated and relationship with body composition. Nutr Hosp. 2017;34(5):1174-81.

    BACKGROUND
  • Práxedes A, et al. Nivel de actividad física y factores de riesgo cardiovascular en universitarios. Retos. 2016;30:157-61.

    BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Not applicable. Due to the nature of the educational and physical activity intervention, neither participants nor study staff could be blinded to group assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study used a parallel-group, controlled educational intervention design. Participants were assigned to either the "Ponte en Forma" supervised physical activity and lifestyle counseling program (intervention group) or to a control group performing unsupervised exercise at the university facilities. Allocation was non-randomized and based on voluntary program enrollment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 5, 2025

Study Start

September 1, 2016

Primary Completion

June 30, 2017

Study Completion

July 31, 2017

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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.