Education for Prevention and Treatment of Frailty

Frailty Clinical Trial

— FRAGSALUD  

Official title:

Randomized Clinical Trial to Assess the Efficacy of an Educational Programme for Prevention and Treatment of Frailty in Older Adults Living in the Community: FRAGSALUD Programme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05610605
• Other study ID #: FRAGSALUD
• Status: Completed
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: September 30, 2023

Study information

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

Clinical Trial Summary

Frailty is a condition with a high prevalence in older adults, leading to higher vulnerability and increasing the risk of adverse health outcomes and disabilities. The aging of the population in Spain is accelerating quickly, consequently, it is necessary to advise the population on the appropriate path to healthy aging, free of fragility and their secondary problems.

Description:

To evaluate the efficacy and efficiency of a Fragsalud program for the prevention and multifactorial treatment of frailty in people over 65 years of age living in the community compared to the usual treatment. Material and methods: A Single blind randomized, two-arm clinical trial; control group and intervention group, multicenter, with 15 months of follow-up, with evaluations blinded at the beginning, and in the follow-up at 12 and 15 months. A recruitment of 196 people over 65 years of age with criteria of pre-frailty or frailty according to Fried's criteria. The Fragsalud education program will be taught in the intervention group; while control group will follow the usual health care. The evolution of the criteria of frailty, cognitive state, eating pattern, emotional state, quality of sleep, perceived social support, quality of life, functional capacity in daily life, adverse results, assessment of self-efficacy and cost-utility analysis variables will be evaluated. Possible confounding factors such as sociodemographic variables, comorbidity and polymedication will be controlled. Intention-to-treat analysis will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients over 65 years of age who present frailty or pre-frailty, assessed using the Fried criteria adapted to Spanish population;
• Patients belonging to Clinical Management Units participating in the study and who will remain in it for the 15 months of the study;
• Patients who can come to the Health Center alone or accompanied.

Exclusion Criteria:

• Patients with no full control of their capabilities.
• Patients who do not understand Spanish;
• Patients with allergies to plastic or metal.
• Patients who are instutionalized.

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty

Intervention

Other:
• Health intervention programme: FRAGSALUD
The FRAGSALUD Program consists in two parts, a first part of health education that will be taught in a group in four sessions, and a second part of individual treatment and follow-up, individual consultations will have a bimonthly periodicity until reaching one year, at which time that the program ends and a final evaluation will be carried out to assess whether the changes are maintained 15 months after the start.

Locations

Country	Name	City	State
Spain	Faculty of Education	Puerto Real	Cádiz

Sponsors (3)

Lead Sponsor	Collaborator
University of Cadiz	Instituto de investigación e innovación biomédica de Cádiz, University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the change of baseline Fried frailty criteria at 6 months	- Fried frailty criteria adapted to the Spanish population: subjects are considered non-frail when no criteria are present, pre-frail if they meet 1 or 2 of the criteria, and frail if they meet 3 to 5 criteria.; Fried frailty criteria are divided into 5: Weight loss, Exhaustion, Physical Activity, Walking time, and Muscle weakness.	Preintervention/Postintervention (0 and 6 months)
Primary	Evaluation of the change of baseline Fried frailty criteria at 12 months	- Fried frailty criteria adapted to the Spanish population: subjects are considered non-frail when no criteria are present, pre-frail if they meet 1 or 2 of the criteria, and frail if they meet 3 to 5 criteria.; Fried frailty criteria are divided into 5: Weight loss, Exhaustion, Physical Activity, Walking time, and Muscle weakness.	Preintervention/Postintervention (0 and 12 months)
Primary	Evaluation of the change of baseline weight change at 6 months	Unintentional weight loss of 5% or more in the last year: it is calculated using the difference between the current weight and that recorded in the medical record in the last year. If not available, the criterion is considered to be met if the answer is positive to Have you lost weight in the last year? and Have you lost more than 3 kg in the last year?	Preintervention/Postintervention (0 and 6 months)
Primary	Evaluation of the change of baseline weight change at 12 months	Unintentional weight loss of 5% or more in the last year: it is calculated using the difference between the current weight and that recorded in the medical record in the last year. If not available, the criterion is considered to be met if the answer is positive to Have you lost weight in the last year? and Have you lost more than 3 kg in the last year?	Preintervention/Postintervention (0 and 12 months)
Primary	Evaluation of the change of baseline exhaustion at 6 months	Self-reported exhaustion or tiredness: they met the criteria if they answered frequently or always in at least one of the 2 questions of the Center for Epidemiologic Studies Depression Scale (CES-D) questionnaire, do I feel that everything I do is an effort? And I don't feel like doing anything?	Preintervention/Postintervention (0 and 6 months)
Primary	Evaluation of the change of baseline exhaustion at 12 months	Self-reported exhaustion or tiredness: they met the criteria if they answered frequently or always in at least one of the 2 questions of the Center for Epidemiologic Studies Depression Scale (CES-D) questionnaire, do I feel that everything I do is an effort? And I don't feel like doing anything?	Preintervention/Postintervention (0 and 12 months)
Primary	Evaluation of the change of baseline physical activity at 6 months	Based on the reduced version of the Minnesota Leisure Time Activity Questionnaire (VREM) validated in Spanish for this age group, which asks about leisure-time physical activity. The kilocalories (Kcal) per week expended are calculated using a standardized algorithm. This variable is stratified by gender. Men: those with <383 Kcals of physical activity per week meet the frailty criteria. Women: those with <270 Kcals per week meet the criteria for frailty.	Preintervention/Postintervention (0 and 6 months)
Primary	Evaluation of the change of baseline physical activity at 12 months	Based on the reduced version of the Minnesota Leisure Time Activity Questionnaire (VREM) validated in Spanish for this age group, which asks about leisure-time physical activity. The kilocalories (Kcal) per week expended are calculated using a standardized algorithm. This variable is stratified by gender. Men: those with <383 Kcals of physical activity per week meet the frailty criteria. Women: those with <270 Kcals per week meet the criteria for frailty.	Preintervention/Postintervention (0 and 12 months)
Primary	Evaluation of the change of baseline walking time at 6 months	The results will be stratified by sex and height. Time limit to walk 4.57 meters for frailty, men taller than 1.63 cm: =6.4 seconds, all others: =7.2 seconds; women with a height over than 1.51 cm: =10.5 seconds, the rest: =11.2 seconds.	Preintervention/Postintervention (0 and 6 months)
Primary	Evaluation of the change of baseline walking time at 12 months	The results will be stratified by sex and height. Time limit to walk 4.57 meters for frailty, men taller than 1.63 cm: =6.4 seconds, all others: =7.2 seconds; women with a height over than 1.51 cm: =10.5 seconds, the rest: =11.2 seconds.	Preintervention/Postintervention (0 and 12 months)
Primary	Evaluation of the change of baseline muscle weakness at 6 months	The grip strength in the dominant hand will be measured with an arch dynamometer (Jamar® digital hand dynamometer) that expresses the force in kilograms. Those who cannot perform the test or according to the cut-off values meet the criteria: body mass index (BMI) equal to or over than 30 (men =15 kg/cm2, women =7 kg/cm2); BMI between 25.1 and 29.9 (men =13 kg/cm2, women =6 kg/cm2), and BMI equal to or less than 25 (men =10 kg/cm2, women =6 kg/cm2).	Preintervention/Postintervention (0 and 6 months)
Primary	Evaluation of the change of baseline muscle weakness at 12 months	The grip strength in the dominant hand will be measured with an arch dynamometer (Jamar® digital hand dynamometer) that expresses the force in kilograms. Those who cannot perform the test or according to the cut-off values meet the criteria: body mass index (BMI) equal to or over than 30 (men =15 kg/cm2, women =7 kg/cm2); BMI between 25.1 and 29.9 (men =13 kg/cm2, women =6 kg/cm2), and BMI equal to or less than 25 (men =10 kg/cm2, women =6 kg/cm2).	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Cognitive status at 6 months	- Cognitive status will be evaluated using The Short Portable Mental Status Questionnaire (SPMSQ) which includes 10 items. Depending on the number of errors, participants will be stratified in: 0-2 errors: normal mental functioning; 3-4 errors: mild cognitive impairment; 5-7 errors: moderate cognitive impairment; 8 or more errors: severe cognitive impairment	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Cognitive status at 12 months	- Cognitive status will be evaluated using The Short Portable Mental Status Questionnaire (SPMSQ) which includes 10 items. Depending on the number of errors, participants will be stratified in: 0-2 errors: normal mental functioning; 3-4 errors: mild cognitive impairment; 5-7 errors: moderate cognitive impairment; 8 or more errors: severe cognitive impairment	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Nutritional status at 6 months	- Nutritional status: the eating pattern will be assessed using the Mini Nutritional Assessment (MNA) test, which is a nutritional assessment and screening method for the elderly population. It consists of two parts: a screening (7 questions), and an evaluation (12 questions). A total score = 24 indicates good nutritional status, between 17-23.5 identifies nutritional risk, and less than 17 the patient presents protein-calorie malnutrition.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Nutritional status at 12 months	- Nutritional status: the eating pattern will be assessed using the Mini Nutritional Assessment (MNA) test, which is a nutritional assessment and screening method for the elderly population. It consists of two parts: a screening (7 questions), and an evaluation (12 questions). A total score = 24 indicates good nutritional status, between 17-23.5 identifies nutritional risk, and less than 17 the patient presents protein-calorie malnutrition.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Emotional state at 6 months	- Emotional state: using the Yesavage geriatric depression scale. It is a questionnaire for depression screening in people over 65 years of age. It consists of 15 questions, each wrong answer scores 1. The cut-off points are: 0-4 normal and 5 or + depression.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Emotional state at 12 months	- Emotional state: using the Yesavage geriatric depression scale. It is a questionnaire for depression screening in people over 65 years of age. It consists of 15 questions, each wrong answer scores 1. The cut-off points are: 0-4 normal and 5 or + depression.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Sleep quality at 6 months	- Self-perceived sleep quality using the Pittsburgh Sleep Quality Index (PSQI), validated in Spanish. 7 components are obtained: subjective quality, sleep latency, sleep duration, "sleep efficiency", sleep disturbances, use of hypnotic medication, daytime dysfunction. The sum of the partial scores generates a total score, which can range from 0-21. According to Buysse et al, a score of 5 would be the cut-off point that would separate subjects who have good sleep quality from those who have poor sleep quality.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Sleep quality at 12 months	- Self-perceived sleep quality using the Pittsburgh Sleep Quality Index (PSQI), validated in Spanish. 7 components are obtained: subjective quality, sleep latency, sleep duration, "sleep efficiency", sleep disturbances, use of hypnotic medication, daytime dysfunction. The sum of the partial scores generates a total score, which can range from 0-21. According to Buysse et al, a score of 5 would be the cut-off point that would separate subjects who have good sleep quality from those who have poor sleep quality.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Social interaction at 6 months	- Social interaction through the Duke-UNC questionnaire of perceived social support, consisting of 11 items and a Likert-type response scale (1-5). The scoring range is between 11 and 55 points. The lower the score, the less support. In the Spanish validation, a cut-off point of <32 was chosen. A score equal to or greater than 32 indicates normal support, while less than 32 indicates low perceived social support.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Social interaction at 12 months	- Social interaction through the Duke-UNC questionnaire of perceived social support, consisting of 11 items and a Likert-type response scale (1-5). The scoring range is between 11 and 55 points. The lower the score, the less support. In the Spanish validation, a cut-off point of <32 was chosen. A score equal to or greater than 32 indicates normal support, while less than 32 indicates low perceived social support.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Health-related Quality of life at 6 months	- Health-related quality of life: the EuroQol-5D-3L questionnaire validated in Spanish will be used, describing five dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety/depression). It also consists of a visual analogue scale (VAS), graduated from 0 to 100 and labeled "worst imaginable health state" and "best imaginable health state", respectively.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Health-related Quality of life at 12 months	- Health-related quality of life: the EuroQol-5D-3L questionnaire validated in Spanish will be used, describing five dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety/depression). It also consists of a visual analogue scale (VAS), graduated from 0 to 100 and labeled "worst imaginable health state" and "best imaginable health state", respectively.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Functional capacity in daily life (Lawton & Brody scale and Barthel index) at 6 months	- Evaluation of functional capacities for personal independence, using the Lawton and Brody scale, which evaluates 8 instrumental activities of daily life in 10 Likert-type items. Depending on the degree of dependence, every item is scored between 0 to 10, with a final puntuation between 0 to 100. Depending on the final score, the degree of dependency is evaluated with the lower the score, the more dependency.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Functional capacity in daily life (Lawton & Brody scale and Barthel index) at 12 months	- Evaluation of functional capacities for personal independence, using the Lawton and Brody scale, which evaluates 8 instrumental activities of daily life in 10 Likert-type items. Depending on the degree of dependence, every item is scored between 0 to 10, with a final puntuation between 0 to 100. Depending on the final score, the degree of dependency is evaluated with the lower the score, the more dependency.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Functional capacity in daily life (Exercise, physical inactivity and sleep) at 6 months	- Assessment of exercise, physical inactivity and sleep that will be carried out using accelerometers for 7 days at the beginning, a year and 15 months. Participants are asked to wear a triaxial accelerometer (GeneActiv, Activinsights Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/) on their non-dominant wrist 24 hours a day. The GeneActiv Recorder contains a triaxial MEMS accelerometer with a range of ± 8 g. and a sensitivity = 0.004 g. It records both motion-related acceleration and gravitational acceleration and has linear and equal sensitivity along all three axes (forward/backward, up/down, left/right). This monitor provides the end user with raw accelerometry data. In this study, the accelerometer will be configured at 40 Hz. For data processing, the system developed for the PREDIMEDPLUS study will be used. The data processing is done with an open source package in R, GGIR version 1.5-12.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Functional capacity in daily life (Exercise, physical inactivity and sleep) at 12 months	- Assessment of exercise, physical inactivity and sleep that will be carried out using accelerometers for 7 days at the beginning, a year and 15 months. Participants are asked to wear a triaxial accelerometer (GeneActiv, Activinsights Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/) on their non-dominant wrist 24 hours a day. The GeneActiv Recorder contains a triaxial MEMS accelerometer with a range of ± 8 g. and a sensitivity = 0.004 g. It records both motion-related acceleration and gravitational acceleration and has linear and equal sensitivity along all three axes (forward/backward, up/down, left/right). This monitor provides the end user with raw accelerometry data. In this study, the accelerometer will be configured at 40 Hz. For data processing, the system developed for the PREDIMEDPLUS study will be used. The data processing is done with an open source package in R, GGIR version 1.5-12.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 6 months	- Assessment of balance by means of single-legged support, it will be requested that they remain as long as possible supported by only one of their lower extremities with their arms at the sides of the trunk. The duration of the test will be considered until one of the following conditions is met: a) The support foot changes position, b) The elevated foot touches the ground, c) The arms come off the trunk, and d) When the leg raised touches the supporting limb. The maximum time considered is 30 seconds. The best time of two attempts will be recorded. Based on the results, the subjects will be divided into two groups. Those who reach a time >5 seconds that will be classified as high performance, and with a score = 5 low performance.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Functional capacity in daily life (Balance assessment) at 12 months	- Assessment of balance by means of single-legged support, it will be requested that they remain as long as possible supported by only one of their lower extremities with their arms at the sides of the trunk. The duration of the test will be considered until one of the following conditions is met: a) The support foot changes position, b) The elevated foot touches the ground, c) The arms come off the trunk, and d) When the leg raised touches the supporting limb. The maximum time considered is 30 seconds. The best time of two attempts will be recorded. Based on the results, the subjects will be divided into two groups. Those who reach a time >5 seconds that will be classified as high performance, and with a score = 5 low performance.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Adverse outcomes at 6 months	- Evaluate the rates of falls, fractures due to falls, hospital admissions, days of hospital admission, interventions, inclusions in home care programs, institutionalizations in residences and deaths. The evaluation will be carried out by consulting the clinical health history and by direct questioning.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Adverse outcomes at 12 months	- Evaluate the rates of falls, fractures due to falls, hospital admissions, days of hospital admission, interventions, inclusions in home care programs, institutionalizations in residences and deaths. The evaluation will be carried out by consulting the clinical health history and by direct questioning.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline self perceived confidence at 6 months	- Evaluation of self-efficacy using the General Self-Efficacy Scale. Consisting of 10 items on a Likert scale ranging from 1 (not at all) to 4 (a lot), the scale assesses the degree to which they perceive self-confidence when managing general activities in daily life. It was developed by Sherer et al., it is validated in Spanish.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline self perceived confidence at 12 months	- Evaluation of self-efficacy using the General Self-Efficacy Scale. Consisting of 10 items on a Likert scale ranging from 1 (not at all) to 4 (a lot), the scale assesses the degree to which they perceive self-confidence when managing general activities in daily life. It was developed by Sherer et al., it is validated in Spanish.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of baseline Cost-utility analysis at 6 months	- Cost-utility analysis, following the recommendations of the proposed guide for economic evaluation applied to health technologies.; Healthcare resources: a) the consumption of healthcare services associated with falls will be analysed: hospital admissions, Primary Care medical and nursing consultations, Primary Care medical and nursing visits at home (during regular hours), emergency medical visits for Primary Care Primary at home, medical consultations in the Hospital (UGC Traumatology and Rehabilitation), emergency medical consultations in the Hospital Center, medication and complementary tests; b) the consumption of services in general will also be analysed: visits to primary nursing and medical care, visits to primary nursing and medical care, visits to the emergency department, visits to medical specialties, hospital admissions and surgical interventions.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of baseline Cost-utility analysis at 12 months	- Cost-utility analysis, following the recommendations of the proposed guide for economic evaluation applied to health technologies.; Healthcare resources: a) the consumption of healthcare services associated with falls will be analysed: hospital admissions, Primary Care medical and nursing consultations, Primary Care medical and nursing visits at home (during regular hours), emergency medical visits for Primary Care Primary at home, medical consultations in the Hospital (UGC Traumatology and Rehabilitation), emergency medical consultations in the Hospital Center, medication and complementary tests; b) the consumption of services in general will also be analysed: visits to primary nursing and medical care, visits to primary nursing and medical care, visits to the emergency department, visits to medical specialties, hospital admissions and surgical interventions.	Preintervention/Postintervention (0 and 12 months)
Secondary	Evaluation of the change of Intervention satisfaction assessed by CSQ-8 at 6 months	- Evaluation of satisfaction with the intervention: the CSQ-8 (Client Satisfaction Questionnaire) will be used, with 8 questions evaluated according to a 4-point Likert-type scale, with specific cut-off points for each of the items. It has been validated in a Spanish-speaking population.	Preintervention/Postintervention (0 and 6 months)
Secondary	Evaluation of the change of Intervention satisfaction assessed by CSQ-8 at 12 months	- Evaluation of satisfaction with the intervention: the CSQ-8 (Client Satisfaction Questionnaire) will be used, with 8 questions evaluated according to a 4-point Likert-type scale, with specific cut-off points for each of the items. It has been validated in a Spanish-speaking population.	Preintervention/Postintervention (0 and 12 months)
Secondary	Change in Sociodemographic data at 6 months	Date of birth, sex, marital status, cohabitation, educational level, amount of pension income.	Preintervention/Postintervention (0 and 6 months)
Secondary	Change in Sociodemographic data at 12 months	Date of birth, sex, marital status, cohabitation, educational level, amount of pension income.	Preintervention/Postintervention (0 and 12 months)
Secondary	Change in Medical data at 6 months	Number and type of chronic pathologies (comorbidities). Number of different medications you take daily and type of medication.	Preintervention/Postintervention (0 and 6 months)
Secondary	Change in Medical data at 12 months	Number and type of chronic pathologies (comorbidities). Number of different medications you take daily and type of medication.	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline Blood Sample (Hematocrit) at 6 months	1. Hematocrit (%)	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline Blood Sample (Hematocrit) at 12months	1. Hematocrit (%)	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline Hemoglobin, protein and albumin sample at 6 months	2. Hemoglobin (g/dL) 3. Total protein (g/dL) 4. Serum Albumin (g/dL)	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline Hemoglobin, protein and albumin sample at 12 months	2. Hemoglobin (g/dL) 3. Total protein (g/dL) 4. Serum Albumin (g/dL)	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline lipids, and plasma creatinine sample at 6 months	5. Lipid profile (mg/dL) 6. Plasma creatinine (mg/dL)	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline lipids, and plasma creatinine sample at 12 months	5. Lipid profile (mg/dL) 6. Plasma creatinine (mg/dL)	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline Blood Sample (Glycosylated hemoglobin) at 6 months	7. Glycosylated hemoglobin (A1C)	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline Blood Sample (Glycosylated hemoglobin) at 12 months	7. Glycosylated hemoglobin (A1C)	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline Biological variables: Weight at 6 months	1. Weight (kilograms)	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline Biological variables: Weight at 12months	1. Weight (kilograms)	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline Biological variables: Height at 6 months	2. Height (meters)	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline Biological variables: Height at 12 months	2. Height (meters)	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline Biological variables: Body Mass Index at 6 months	3. Body Mass Index (kg/m^2)	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline Biological variables: Body Mass Index at 12 months	3. Body Mass Index (kg/m^2)	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline Biological variables: Waist circunference at 6 months	4. Waist circunference (cm)	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline Biological variables: Waist circunference at 12 months	4. Waist circunference (cm)	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline Biological variables: Blood pressure at 6 months	5. Systolic and diastolic Blood pressure (mmHg)	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline Biological variables: Blood pressure at 12 months	5. Systolic and diastolic Blood pressure (mmHg)	Preintervention/Postintervention (0 and 12 months)
Secondary	Assessed changes from Baseline Smoking and alcohol habits	Number of cigarettes per day; Number of alcoholic drinks per day	Preintervention/Postintervention (0 and 6 months)
Secondary	Assessed changes from Baseline Smoking and alcohol habits	Number of cigarettes per day; Number of alcoholic drinks per day	Preintervention/Postintervention (0 and 12 months)