Healthy LifestylePONTE-FORMANCT07268144
Effectiveness of a Supervised University-Based Physical Activity and Health Education Program on Lifestyle and Psychological Well-being (Ponte en Forma)
A study testing Ponte en Forma Program in people with Healthy Lifestyle and Cardiovascular Risk Factors, run by Fundacin Biomedica Galicia Sur.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Cardiovascular Risk Factors, Sedentary Behavior
- What is being tested?
- Ponte en Forma Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Lifestyle, Cardiovascular Risk Factors, Sedentary Behavior, Psychological Well-being, Health Promotion
- Being tested
- Ponte en Forma Program
- Keywords
- University health promotion, Physical activity intervention, Mediterranean diet adherence, Lifestyle behavior change, Psychological well-being, Self-esteem, Emotional intelligence, Non-communicable diseases prevention, Young adults, Controlled educational intervention
- Medical subject headings
- Sedentary Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ponte en Forma ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic and Diastolic Blood Pressure (SBP and DBP)
Mean change in systolic and diastolic blood pressure (mmHg) from baseline to 4 months.
Measured: 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.
Measured: Baseline and Month 4
Change in Resting Heart Rate (HR)
Mean change in resting heart rate (beats per minute) from baseline to 4 months.
Measured: 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.
Measured: Baseline and Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Sep 2016
- Primary completion30 Jun 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268144
- Sponsor's protocol ID
- PonteEnForma-UVIGO-2016
- Other IDs
- 2016/567
- Acronym
- PONTE-FORMA
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 8628042Craig 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.
PubMed 12900694Salovey 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.
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.
PubMed 21508208Sánchez 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.
Práxedes A, et al. Nivel de actividad física y factores de riesgo cardiovascular en universitarios. Retos. 2016;30:157-61.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Supervised University-Based Physical Activity and Health Education Program on Lifestyle and Psychological Well-being: A Controlled Educational Intervention Study
- ClinicalTrials.gov ID
- NCT07268144
- Acronym / sponsor ID
- PONTE-FORMA / PonteEnForma-UVIGO-2016
- Conditions
- Healthy Lifestyle, Cardiovascular Risk Factors, Sedentary Behavior, Psychological Well-being, Health Promotion
- Keywords
- University health promotion, Physical activity intervention, Mediterranean diet adherence, Lifestyle behavior change, Psychological well-being, Self-esteem, Emotional intelligence, Non-communicable diseases prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Ponte en Forma Program | Experimental | Behavioral: Ponte en Forma ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ponte en Forma ProgramA 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 | Behavioural | Intervention Arm - Ponte en Forma Program |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 8628042Ware 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.
- Background: PubMed 12900694Craig 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.
- BackgroundSalovey 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: PubMed 21508208Schroder 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.
- BackgroundSánchez 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.
- BackgroundPráxedes A, et al. Nivel de actividad física y factores de riesgo cardiovascular en universitarios. Retos. 2016;30:157-61.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ponte en Forma Program in people with Healthy Lifestyle and Cardiovascular Risk Factors, run by Fundacin Biomedica Galicia Sur.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic and Diastolic Blood Pressure (SBP and DBP) (time frame: Baseline and Month 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07268144, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.