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Completed

NCT Number: NCT05420116

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

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

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Transfronterer de Cerdanya

Puigcerdà, Catalonia, 17520, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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..)

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline of frecuency and intensity of pysical activity

    Time frame: 9 months

    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.

  2. Change from baseline mediterrainian diet on 14 points on the scale of adherence to the Mediterranean diet.

    Time frame: 9 months

    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

  3. Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale

    Time frame: 9 months

    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.

  4. Change from baseline of the BMI of participants. Weight and height will be combined to report BMI in kg/m^2

    Time frame: 2 months

    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.

  5. Change from baseline of watter percentage with a bioimpedance scale

    Time frame: 2 months

    Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602

  6. Change from baseline of fat mass percentage with a bioimpedance scale

    Time frame: 2 months

    Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602

  7. Change from baseline of fat free mass percentage with a bioimpedance scale

    Time frame: 2 months

    Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602

  8. change in the baseline of the caryovascular risk index with the waist-hip measurement

    Time frame: 9 months

    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. Change from baseline of fat percentage and fat Kg on anthropometric measurements

    Time frame: 9 months

    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

  10. Change from baseline of muscle percentage and muscle kg on anthropometric measurements

    Time frame: 9 months

    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

  11. Change from baseline of bone percentage on anthropometric measurements

    Time frame: 9 months

    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

  12. Change from baseline of glucose and cholesterol on blood test

    Time frame: 9 months

    Test levels of HDL, LDL, Triglicerids, Cholesterol Total. Mesured in mg/dL

  13. Change from baseline of glucose and cholesterol on blood test

    Time frame: 9 months

    Test levels of glucose. Mesured in mg/dL

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Collaborators

  • Hospital of Cerdanya, Spain

Registry information

Official study 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.

Acronym: CF

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 15, 2022
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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