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

NCT05420116 | Completed DMC

• 1 other identifier: 2038
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

physical activity,; healthy lifestyle; Mental Health

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Cerdanya on Fitness 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years
• Body Mass Index 30-40

You may not qualify if:

• 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..)

Sponsors & Collaborators

• University of Barcelona: lead
• Hospital of Cerdanya, Spain: collaborator

Study Sites (1)

Hospital Transfronterer de Cerdanya

Puigcerdà, Catalonia, 17520, Spain

Location

Related 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).

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Obesity; Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction

Study Officials

• Marta Prats-Arimon, PHD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Model pre-post test in intervention group and pre-post usual follow up in control group

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 15, 2022
• Study Start: January 10, 2020
• Primary Completion: September 1, 2020
• Study Completion: January 10, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from June 2020 until the article will be published
• 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

Locations

ES (1)