"Program "Cerdanya on Fitness" to Improve the Lifestyle of People With Obesity in Cerdanya (CF).

NCT ID: NCT05420116

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2021-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the effectiveness of an intervention program called "Cerdanya on fitness" based on the prescription of physical activity, healthy nutritional habits and the promotion of positive mental health, adapted to people with obesity to improve their lifestyle and psychoemotional wellbeing

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Previous phase:Presentation of the protocol to doctors and nurses of the primary health care center.

Phase 1: After being informed about the study and the possible risks, all patients who give their written informed consent will undergo.

-1) 4 weeks of screening to determine eligibility to enter the study. Referral of patients who meet the inclusion/exclusion criteria to enter the Cerdanya on fitness program by the nursing consultation.

Phase I protocol data collection (physical activity scale, positive mental health scale, Mediterranean diet scale, sociodemographic variables will also be collected week 0) Patients who meet the eligibility requirements will be randomized in a non-blinded fashion. (control group and research group) (5 weeks)

weeks 1-2: Initial assessment of physical fitness and dietary habits in the intervention group (blood test- stress test- anthropometry)

week 3-39: Implementation of the intervention (nutritional, physical activity and psychosocial) to the intervention group. The control group will continue with the usual nursing controls in the primary care center.

40-41 week: Final evaluation of the physical condition and eating habits of the intervention group (blood test, stress test, anthropometry): Final data collection of the control and intervention group (physical activity scale, positive mental health scale, Mediterranean diet scale).

Translated with www.DeepL.com/Translator (free version)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Model pre-post test in intervention group and pre-post usual follow up in control group
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Physical Activity: Prescription in physical activity include to perform 1 session a week of exercice led by a sports professional, and 2 sessions of authonomus exercice at 60-80% of participants maximum heart rate.

Nutritional: Visits and checks every 2 months with a nutritionist with the aim of improving healthy eating habits.

Positive Mental Health: There are 4 group psycho-emotional sessions based on improving self-esteem, self-control, proactive social attitude and conflict resolution

Group Type EXPERIMENTAL

Cerdanya on Fitness

Intervention Type BEHAVIORAL

The intervention lasts 9 months. The participants will carry out group activities and will be followed individually by the different interdisciplinary professionals. Goals will be set for each visit. Before and after the training there will be an assessment of physical exercise, nutritional and positive mental health habits.

Control group

Participants follow the habitual controls in nursing consultation. Recomendations of physical activity and diet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cerdanya on Fitness

The intervention lasts 9 months. The participants will carry out group activities and will be followed individually by the different interdisciplinary professionals. Goals will be set for each visit. Before and after the training there will be an assessment of physical exercise, nutritional and positive mental health habits.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>18 years
* Body Mass Index 30-40

Exclusion Criteria

* Serious cognitive impairment
* Serious mental disorder
* Impossibility of performing physical activity for medical diagnosis (IAM \< 3 months, hemorrhagic stroke \< 3 months, major surgery \< 3 months)
* Severe mobility difficulties (people with use of devices such as cane, walker, wheelchair..)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital of Cerdanya, Spain

UNKNOWN

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marta Prats Arimon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marta Prats-Arimon, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Transfronterer de Cerdanya

Puigcerdà, Catalonia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Prats-Arimon, M., Barceló-Peiró, O., Ribot-Domènech, I., Heras-Ojea, M., Pérez-Chirinos, C., Vilalta-Serarols, C., Fontecha-Valero, B., Puig-Llobet, M. y Lluch-Canut, M.T. (2020).

Reference Type BACKGROUND

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2038

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ENERGY2MOB STUDY: OBESITY MANAGEMENT IN BERGUEDÀ
NCT06988904 NOT_YET_RECRUITING NA
Exercise to Fight Obesity
NCT06934681 RECRUITING NA
Health and Wellness in Obesity
NCT02102061 UNKNOWN NA