- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268144
Effectiveness of a Supervised University-Based Physical Activity and Health Education Program on Lifestyle and Psychological Well-being (Ponte en Forma) (PONTE-FORMA)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Práxedes A, et al. Nivel de actividad física y factores de riesgo cardiovascular en universitarios. Retos. 2016;30:157-61.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PonteEnForma-UVIGO-2016
- 2016/567 (Other Identifier: Ethics Committee Approval)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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