Clinical trial NCT05420116: "Program "Cerdanya on Fitness" to Improve the Lifestyle of People With Obesity in Cerdanya (CF).
Official title: Pilot Study of the " Cerdanya on Fitness" Program to Promote the Physical Exercise, Healthy Nutritional Habits and Psycho-emotional Well-being of Obese People in Cerdanya. Pilot Study of the "Cerdanya on Fitness" Program to Promote Physical Exercise, Healthy Nutritional Habits and Psychoemotional Well-being of People With Obesity in Cerdanya.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: physical activity,
healthy lifestyle
Mental Health
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Hospital of Cerdanya, Spain
First posted: 2022-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Model pre-post test in intervention group and pre-post usual follow up in control group
Primary purpose: PREVENTION

Brief summary: 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: 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).

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Eligibility criteria: 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..)

Primary outcomes:
measure: Change from baseline of frecuency and intensity of pysical activity
timeFrame: 9 months
measure: Change from baseline mediterrainian diet on 14 points on the scale of adherence to the Mediterranean diet.
timeFrame: 9 months
measure: Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale
timeFrame: 9 months
measure: Change from baseline of the BMI of participants. Weight and height will be combined to report BMI in kg/m^2
timeFrame: 2 months
measure: Change from baseline of watter percentage with a bioimpedance scale
timeFrame: 2 months
measure: Change from baseline of fat mass percentage with a bioimpedance scale
timeFrame: 2 months
measure: Change from baseline of fat free mass percentage with a bioimpedance scale
timeFrame: 2 months
measure: change in the baseline of the caryovascular risk index with the waist-hip measurement
timeFrame: 9 months
measure: Change from baseline of fat percentage and fat Kg on anthropometric measurements
timeFrame: 9 months
measure: Change from baseline of muscle percentage and muscle kg on anthropometric measurements
timeFrame: 9 months
measure: Change from baseline of bone percentage on anthropometric measurements
timeFrame: 9 months
measure: Change from baseline of glucose and cholesterol on blood test
timeFrame: 9 months
measure: Change from baseline of glucose and cholesterol on blood test
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Puigcerda
country: Spain
facility: Hospital Transfronterer de Cerdanya
state: Catalunya
Study officials:
affiliation: University of Barcelona
name: Marta Prats-Arimon, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).