Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project

Depression Clinical Trial

— SONRIE  

Official title:

Internet-based Physical Activities Randomized Controlled Trial in Patients With Mild/Moderate Depression: Effects on Psychological and Social Well-being: SONRIE Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05849792
• Other study ID #: PI/0068/2018
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: April 2023
• Source: University of Cadiz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized controlled trial is to determine the effect of an intervention program with physical activity for 12 weeks on depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression. The main questions it aims to answer are: 1. - To determine the association of physical activity levels, sedentary behavior, sleep patterns, physical condition, diet, and general health status with mental and social well-being, and quality of life in a large sample of adult patients diagnosed with mild or moderate depression. 2. - To examine the predictive capacity of physical activity, sedentary behaviors, and physical condition on mild and moderate depressive disorder. 3. - To study the effect of a period without an intervention program with physical activity (8 weeks without exercise intervention) on the variables studied. 4. - To examine the role of the endocannabinoid system on depression as well as its behavior after an intervention program of physical activity. Participants will be involved in a physical activity intervention program for 12 weeks. Researchers will compare intervention group and control group to see if an intervention program with physical activity for 12 weeks improve depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression.

Description:

One hundred and six eligible participants between 25-65 years old (Spanish higher prevalence of depression in adulthood) diagnosed with mild or moderate depression will be the sample of this project. Participants will be recruited from the Mental Health Unit (UGC Salud Mental), covering different areas of the province of Cadiz (Spain) such as Puerto Real, Chiclana de la Frontera and Vejer de la Frontera. The Mental Health Unit Director from Puerto Real Hospital is a researcher associated with this project who has specific experience with clinical experience. He will be the person in charge for the clinical depression diagnosis. Moreover, participants will perform specific depression tests at the time of recruitment to confirm their clinical status. Individuals who meet the criteria to participate in this study will sign the informed consent previously to their inclusion in this project (see inclusion / exclusion criteria section). Sample size and statistical power Sample size determination will be estimated with a 5% type I error (α) and 95% confidence interval establishing a level of precision (d = 0.095) for the hypothesis test to comparing two proportions. The desired sample size will be n = 96 participants and it will be increased by 10% (n = 106) to compensate the possible dropout of participants during the evaluation process of the study. Sample size for the hypothesis test to comparing two means for the intervention study will consider with a significance level alpha of 0.05 and a power of 0.95 (beta = 0.05) and considering the standard deviation for depression variable as 9.36 (Bouldering psychotherapy reduces depressive symptoms even when general physical activity is controlled for: A randomized controlled trial, Heylon, 2018; Mar; 4 (3): e00580). In this way, to detect a minimum mean difference of 8.26 between control and experimental groups for the depression variable, it is estimated that the sample size of each group should be 30 patients. Therefore, a total of 60 participants will be randomly recruited to each group balanced by sex, age and depression clinical severity. It should be taking into account that several simulations to estimate the sample size based on previous studies were performed by STATA statistical software vs. 14.0.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 30, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female participants between 25-65 years.
• Mild and / or moderate depression diagnosed by Beck Scale.
• Do not have other severe somatic or psychiatric disorders or other diseases that prevents physical activity.
• To be able to communicate with any problem.
• To be able to read and understand the main purpose of the study.
• Informed consent: must be capable and willing to provide consent.

Exclusion Criteria:

• Major depression diagnosed.
• Acute or terminal illness.
• History of cerebral infarction, epilepsy, brain tumor.
• Unstable cardiovascular disease, or other medical conditions.
• Upper or lower extremity fracture in the past 3 months.
• Severe visual or auditory problems.
• Unwillingness to either complete the study requirements or to be randomized into control or training group.
• To be a participant in another research study that may influence the present project.

Related Conditions & MeSH terms

• Adult ALL
• Depression
• Depressive Disorder
• Exercise
• Physical Fitness
• Psychological

Intervention

Behavioral:
• Exercise and psychological intervention
Physical Exercise Intervention Sixty-minute sessions were delivered via internet, three times per week (1 supervised) over the first four weeks of the COVID-19 home confinement. The intervention was a multicomponent exercise program lead by a specialist in fitness composed of aerobic, resistance, balance, coordination, mobility and stretching exercises. Each multicomponent exercise session consisted of a 10 min warm-up, 40 min of moderate to vigorous intensity physical activity, and 10 min cool down. Psychological intervention The internet-based-psychological intervention provided to different component of Cognitive Behavioral Therapy (CBT) guided and recorded by a sport neuro-psychologist specialist. The iCBT is based on the protocol for face-to-face CBT for depression. The program consisted of 4 weeks composed of 2 weekly video-guided sessions, with a maximum duration of 30 minutes. iCBT was focused on 4 main axes of action physiological, emotional, behavioral and cognitive.

Locations

Country	Name	City	State
Spain	University of Cádiz	Puerto Real	Cádiz

Sponsors (3)

Lead Sponsor	Collaborator
University of Cadiz	Consejería de Salud y Familia (Junta de Andalucía), Institute of Biomedical research and innovation of Cádiz (INIBICA)

Country where clinical trial is conducted

Spain, 

References & Publications (13)

BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. — View Citation

Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci. 2005 May;8(5):585-9. doi: 10.1038/nn1457. — View Citation

Diaz D, Rodriguez-Carvajal R, Blanco A, Moreno-Jimenez B, Gallardo I, Valle C, van Dierendonck D. [Spanish adaptation of the Psychological Well-Being Scales (PWBS)]. Psicothema. 2006 Aug;18(3):572-7. Spanish. — View Citation

Gonzalez Carrascosa R, Bayo Monto JL, Meneu Barreira T, Garcia Segovia P, Martinez-Monzo J. Design of a self-administered online food frequency questionnaire (FFQ) to assess dietary intake among university population. Nutr Hosp. 2011 Nov-Dec;26(6):1440-6. doi: 10.1590/S0212-16112011000600035. — View Citation

Kroes R, Muller D, Lambe J, Lowik MR, van Klaveren J, Kleiner J, Massey R, Mayer S, Urieta I, Verger P, Visconti A. Assessment of intake from the diet. Food Chem Toxicol. 2002 Feb-Mar;40(2-3):327-85. doi: 10.1016/s0278-6915(01)00113-2. — View Citation

Martinez-Gonzalez MA, Fernandez-Jarne E, Serrano-Martinez M, Wright M, Gomez-Gracia E. Development of a short dietary intake questionnaire for the quantitative estimation of adherence to a cardioprotective Mediterranean diet. Eur J Clin Nutr. 2004 Nov;58(11):1550-2. doi: 10.1038/sj.ejcn.1602004. — View Citation

Pietrobelli A, Rubiano F, St-Onge MP, Heymsfield SB. New bioimpedance analysis system: improved phenotyping with whole-body analysis. Eur J Clin Nutr. 2004 Nov;58(11):1479-84. doi: 10.1038/sj.ejcn.1601993. — View Citation

Richter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. A review. Psychopathology. 1998;31(3):160-8. doi: 10.1159/000066239. — View Citation

Ryff, C. D. Happiness is everything, or is it? Explorations on the meaning of psychological well-being. J. Pers. Soc. Psychol. 57, 1069-1081 (1989)

Spielberger CD, Gorsuch RL, L. R. State-trait anxiety inventory. Palo Alto Consult. Psychol. Press 1-23 (1970)

Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. doi: 10.1157/13074369. Spanish. — View Citation

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression PRE	Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured before the intervention program.	month 11-12
Primary	Depression POST	Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Depression RET	Beck Depression Scale is composed of 21 items that evaluate severity of depression through the assessment of clinical symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, thoughts or wishes of suicide, pessimism, etc. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Anxiety disorders and stress PRE	State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured before the intervention program.	month 11-12
Primary	Anxiety disorders and stress POST	State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Anxiety disorders and stress RET	State Anxiety Inventory (STAI), composed of 40 items designed by sentences that describe how the person feels at that moment and how they usually feel, is a measure of trait and state anxiety. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Light physical activity PRE	Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.	month 11-12
Primary	Light physical activity POST	Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Light physical activity RET	Light physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Moderate physical activity PRE	Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.	month 11-12
Primary	Moderate physical activity POST	Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Moderate physical activity RET	Moderate physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Vigorous physical activity PRE	Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.	month 11-12
Primary	Vigorous physical activity POST	Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Vigorous physical activity RET	Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Moderate-Vigorous physical activity PRE	Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.	month 11-12
Primary	Moderate-Vigorous physical activity POST	Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Moderate-Vigorous physical activity RET	Vigorous physical activity will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Cardiorespiratory fitness PRE	Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured before the intervention program.	month 11-12
Primary	Cardiorespiratory fitness POST	Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Cardiorespiratory fitness RET	Measured by the 6-min walking test, which consist of walking the maximum distance possible in 6 minutes. The outcome will be measured in meters. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	30-s chair stand PRE	This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured before the intervention program.	month 11-12
Primary	30-s chair stand POST	This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	30-s chair stand RET	This test consists of getting up and sitting down in a chair as many times as possible in 30 seconds. It measures the ability to get up and sit down in a chair and the result obtained is measured in repetitions. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Chair sit and reach PRE	The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured before the intervention program.	month 11-12
Primary	Chair sit and reach POST	The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Chair sit and reach RET	The subject is seated on a chair, with one leg extended (the one corresponding to the dominant side). In this position he should try to reach the balls of his feet with his hands without bending the knee. With a tape measure we measure the distance between the tips of the fingers and the tips of the feet. If it does not arrive, the value will be negative. If the value arrives, it will be positive. The flexibility of the lower back, hip extensors and knee flexors is evaluated and the result obtained is measured un centimeters. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Back scratch PRE	The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured before the intervention program.	month 11-12
Primary	Back scratch POST	The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Back scratch RET	The subject will begin the test in anatomical position, then we will tell him to flex one elbow and raise it behind his head towards his back, the next thing he has to do is bring his opposite arm behind his back and try to touch his middle fingers . It can happen that the fingers touch hearts and it would be zero, if they do not touch we measure with a ruler and it would be negative and if it exceeds we measure positive. It is not allowed under any circumstances to hold the fingers. The arm that goes up is the one that is measured. The flexibility of the upper body is evaluated, specifically of the shoulders and the result obtained is measured in centimeters. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Blind flamingo PRE	Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.	month 11-12
Primary	Blind flamingo POST	Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Blind flamingo RET	Starting from a standing position, bipedalism, and closed-eyes bring the arms bent to the waist. One leg is raised and we put the big toe of the foot that we have flexed in contact with the ankle of the opposite leg. We will be measuring the leg that is in support with the ground. You have to try to be 60 seconds without falling or losing balance. It will be considered imbalance: removing the hands from their position, removing the contact of the big toe with the ankle, moving the foot that I have in contact with the ground. The static balance of the leg in contact with the ground is evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	8 ft. up and go PRE	It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured before the intervention program.	month 11-12
Primary	8 ft. up and go POST	It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	8 ft. up and go RET	It is executed with the participant seated in a chair against the wall, the performer, with his back touching the back of the chair. A cone will be placed at a distance of 2.45m (8 feet) and the test consists of getting up, going around the cone and sitting down in the shortest possible time, without there being a flight phase, that is, you cannot run. Stop the timer when your back touches the back of the chair. It doesn't matter which way you turn the cone. To get up, it is important not to rest your hands on your thighs, normally you are told to cross your arms. Dynamic balance, agility and coordination are evaluated and the result obtained is measured in seconds. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Handgrip strength PRE	This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured before the intervention program.	month 11-12
Primary	Handgrip strength POST	This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Handgrip strength RET	This test, also known as a hand grip test, is performed with a dynamometer, which comes in two types, manual and electronic. It measures the force in kilograms, we need to regulate the length of the grip, but it has been shown that there is an optimal grip for men and for women and children. For men it is 5.5 cm. The measurement will be carried out alternately in each hand and a total of two measurements in each hand. Looking straight ahead and there can be no wrist movement, the subject will be told to hold the force for about 3 seconds. The factor that this test evaluates is the isometric strength of the hand and forearm and the result obtained is measured in kilograms. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Anandamine (AEA) PRE	Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.	month 11-12
Primary	Anandamine (AEA) POST	Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Anandamine (AEA) RET	Anandamine (AEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	2-araquinodilglicerol (2-AG) PRE	2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.	month 11-12
Primary	2-araquinodilglicerol (2-AG) POST	2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.	month 18-19
Primary	2-araquinodilglicerol (2-AG) RET	2-araquinodilglicerol (2-AG) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	N-palmitoylethanolamide (PEA) PRE	N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.	month 11-12
Primary	N-palmitoylethanolamide (PEA) POST	N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.	month 18-19
Primary	N-palmitoylethanolamide (PEA) RET	N-palmitoylethanolamide (PEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	N-oleylethanolamine (OEA) PRE	N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured before the intervention program.	month 11-12
Primary	N-oleylethanolamine (OEA) POST	N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured immediately after the intervention program.	month 18-19
Primary	N-oleylethanolamine (OEA) RET	N-oleylethanolamine (OEA) will be quantified by isotopic dilution, liquid chromatography/ electrospray ionization tandem mass spectrometry (LC-ESI-MS). That measurements will be measured 4 weeks after the intervention program.	month 22-23
Primary	Brain-derived neurotrophic factor PRE	It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured before the intervention program.	month 11-12
Primary	Brain-derived neurotrophic factor POST	It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured immediately after the intervention program.	month 18-19
Primary	Brain-derived neurotrophic factor RET	It will be analysed in serum by using indirect enzyme-linked immunosorbent assay (ELISA Kit, Chemicon, Temecula, CA, USA) of RAyBio Human BDNF (RAFER). That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Ryff's Psychological Well-Being Scale (42-item) PRE	Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294. That measurements will be measured before the intervention program.	month 11-12
Secondary	Ryff's Psychological Well-Being Scale (42-item) POST	Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Ryff's Psychological Well-Being Scale (42-item) RET	Ryff's Psychological Well-Being Scale, evaluates optimal psychological functioning and experience in life. It is composed of 29 items grouped in 6 core dimensions: self-acceptance, positive relationships, autonomy, environmental control, purpose in life, and personal growth. The Ryff's Scale can obtain values from 42 to 294, being 42 the worst score. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	The SF-36 Health Questionnaire PRE	The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured before the intervention program.	month 11-12
Secondary	The SF-36 Health Questionnaire POST	The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	The SF-36 Health Questionnaire RET	The SF-36 Health Questionnaire is made up of 36 questions (items) that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical function, Physical role, Bodily pain, General health, Vitality, Social function, Emotional role, and Mental health. The SF-36 can obtain values from 0 to 100, being 0 the worst score. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Blood pressure PRE	Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured before the intervention program.	month 11-12
Secondary	Blood pressure POST	Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Blood pressure RET	Resting blood pressure (systolic and diastolic) will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be mmHg (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Heart rate PRE	Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured before the intervention program.	month 11-12
Secondary	Heart rate POST	Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Heart rate RET	Heart rate will be measured twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute) (M6 upper arm blood pressure monitor Omron, Omron Health Care Europe B.V. Hoolddorp, The Netherlands). That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Weight PRE	Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured before the intervention program.	month 11-12
Secondary	Weight POST	Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Weight RET	Weight will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Height PRE	Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured before the intervention program.	month 11-12
Secondary	Height POST	Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Height RET	Height will be assessed in accordance with the ISAK guidelines with a stadiometer SECA 217 following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Waist circumference PRE	Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured before the intervention program.	month 11-12
Secondary	Waist circumference POST	Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Waist circumference RET	Waist circumference will be assessed in accordance with the ISAK guidelines with a circumference tape SECA following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Fat mass PRE	Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured before the intervention program.	month 11-12
Secondary	Fat mass POST	Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Fat mass RET	Fat mass will be assessed in accordance with the ISAK guidelines with a Tanita MC-780 MA, 8 electrodes following the standardized protocol. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Sociodemographic characteristics questionnaire PRE	Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured before the intervention program.	month 11-12
Secondary	Sociodemographic characteristics questionnaire POST	Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Sociodemographic characteristics questionnaire RET	Age, sex, marital status, educational level, socioeconomic status, family history of depression, self-rated health status, consumption of medicines and other pathologies will be determined by this questionnaires. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Food Frequency Questionnaire (FFQ) PRE	food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured before the intervention program.	month 11-12
Secondary	Food Frequency Questionnaire (FFQ) POST	food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Food Frequency Questionnaire (FFQ) RET	food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	Sleep time PRE	Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured before the intervention program.	month 11-12
Secondary	Sleep time POST	Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	Sleep time RET	Sleep time will be assessed by accelerometers (Actigraph GT3X, MTI, USA) for seven consecutive days with a minimum of 3 days (1 day from weekend) and at less 8 valid hours/day of data collection. The ActiLife Software version 6.13.3 will be used to manage the data. That measurements will be measured 4 weeks after the intervention program.	month 22-23
Secondary	The Pittsburg Sleep Quality Index PRE	The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured before the intervention program.	month 11-12
Secondary	The Pittsburg Sleep Quality Index POST	The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured immediately after the intervention program.	month 18-19
Secondary	The Pittsburg Sleep Quality Index RET	The Pittsburg Sleep Quality Index will be administer to assess sleep quality and disturbances over a month time interval. It is self-rated questionnaire composed of 19 items that assess 7 components of sleep, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. That measurements will be measured 4 weeks after the intervention program.	month 22-23