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

Obesity Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05420116
• Other study ID #: 2038
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: January 10, 2021

Study information

• Verified date: June 2022
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 10, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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..)

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Transfronterer de Cerdanya	Puigcerda	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
University of Barcelona	Hospital of Cerdanya, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of frecuency and intensity of pysical activity	CLASS AF is a rapid classification scale for physical activity. It is measured based on physical activity at work and physical activity in leisure time, taking into account minutes and frequency. From the formula: 2 x L + Ll x frq 2, the person is classified as sedentary, minimally active, mildly active, moderately active or very active.	9 months
Primary	Change from baseline mediterrainian diet on 14 points on the scale of adherence to the Mediterranean diet.	The scale of adherence to the Mediterranean diet, is a scale based on 14 items where you ask about 7 groups of foods and portions characteristic of this diet. each item must score with a 1 or 0 depending on the fulfilled or not. The sum of the points if it is less than 9 indicates a bad grip if it is equal to or greater than 9 , a good grip	9 months
Primary	Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale	The SMP multifactorial scale consists of 39 items that are distributed among 6 factors: Personal Satisfaction, Prosocial Attitude, Self-Control, Autonomy, Problem Solving and Self-Update, and Interpersonal Relationship Skills. The evaluation of each item is done with a scale scale ranging from 1 to 4. Being 1, always or almost always, 2, quite often, 3 often and 4, never or almost never. Finally, a score between 39 and 156 is obtained, the higher the score the more positive mental health.	9 months
Primary	Change from baseline of the BMI of participants. Weight and height will be combined to report BMI in kg/m^2	Weigh will be mesured with a analogic weighing machine in Kilograms. Participants are mesured only with underwear clouths. Height will be mesured in m^2.	2 months
Primary	Change from baseline of watter percentage with a bioimpedance scale	Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602	2 months
Primary	Change from baseline of fat mass percentage with a bioimpedance scale	Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602	2 months
Primary	Change from baseline of fat free mass percentage with a bioimpedance scale	Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602	2 months
Primary	change in the baseline of the caryovascular risk index with the waist-hip measurement	The waist-hip ratio (IC-C) is a specific anthropometric measurement to measure the levels of intra-abdominal fat, it relates the perimeter of the waist to that of the hip (in centimeters) and depending on the result it is estimated if there is a certain cardiovascular risk.; The WHO establishes normal levels of 0.8 in women and 1 in men; higher values would indicate	9 months
Primary	Change from baseline of fat percentage and fat Kg on anthropometric measurements	The specific anthropometric measurements for people with obesity according to ISAK are 3 skin folds mesured in mm 3 diameters and 2 perimeters (.Waist circumference 1: at rib height, waist circumference 2: 2 cm above the navel.; The percentage of fat is determined from specific formula. (F Weltman) Mesured in kg and percentage	9 months
Primary	Change from baseline of muscle percentage and muscle kg on anthropometric measurements	The specific anthropometric measurements for people with obesity according to ISAK are 3 perimeters (triceps muscles, calf muscles, quadriceps muscles) . The percentage of muscle is determined from specific formulas.( F Lee) mesured in kg and percentage	9 months
Primary	Change from baseline of bone percentage on anthropometric measurements	The specific anthropometric measurements for people with obesity according to ISAK are 3 diameters. The percentage of bone is determined from specific formulas.(F Rocha) Mesured in kg and percentage	9 months
Primary	Change from baseline of glucose and cholesterol on blood test	Test levels of HDL, LDL, Triglicerids, Cholesterol Total. Mesured in mg/dL	9 months
Primary	Change from baseline of glucose and cholesterol on blood test	Test levels of glucose. Mesured in mg/dL	9 months

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