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

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.

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Cerdanya on Fitness

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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• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalunya
    • Puigcerda, Catalunya, Spain, 17520
      • Hospital Transfronterer de Cerdanya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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..)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
No Intervention: Control group; Participants follow the habitual controls in nursing consultation. Recomendations of physical activity and diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
Change from baseline of glucose and cholesterol on blood test	Test levels of HDL, LDL, Triglicerids, Cholesterol Total. Mesured in mg/dL	9 months
Change from baseline of glucose and cholesterol on blood test	Test levels of glucose. Mesured in mg/dL	9 months

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: Hospital of Cerdanya, Spain
• Investigators: Principal Investigator: Marta Prats-Arimon, PHD, University of Barcelona

Publications and helpful links

General Publications

• 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).

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): January 10, 2021

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Mental Health; healthy lifestyle; physical activity,
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected IPD when the periode of collecting data is finished.
• IPD Sharing Time Frame: from June 2020 until the article will be published
• IPD Sharing Access Criteria: All team researchers from University of Barcelona and Hospital de Cerdanya can share IPD throught SPSS program by corporative mail.All researchers need a password to access the institution's intranet. In addition, a shared folder will be generated where only researchers have access to share other documents
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No