Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02929472
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2016-09-29
Brief Title:
Effect of a Multicomponent Intervention in Children and Adolescents
Sponsor:
Clarice Maria de Lucena Martins
Organization:
Federal University of Paraíba
Study Overview
Official Title:
Effect of a Multicomponent Intervention on Physical Fitness and Metabolic Risk Markers in Children and Adolescents A Pilot Study
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to evaluate the effectiveness of a multicomponent pilot intervention in improving physical fitness PF and metabolic risk markers in children and adolescents and examine if possible changes in PF are associated with metabolic risk markers in children and adolescents exposed to intervention For such a multicomponent pilot intervention was performed consisting of sessions of physical exercise and nutrition educationThe study included 35 children and adolescents ages 7-13 divided into two groups a intervention group INT n 17 and a control one CONT n 18 The sample underwent two moments of data collection T0 and T1 The 1-hour exercise sessions were held based on an intensity above 65 of maximum HR To assess the metabolic risk markers analyzes of total cholesterol HDL-C fraction LDL-c fraction triglycerides blood glucose insulin aspartate aminotransferase AST and alanine aminotransferase ALT were conducted in T0 and T1 Physical activity PA was assessed by accelerometry Actigraph GT3-X model Florida for 10 consecutive days The health related PF components were evaluated throw different tests 20m Shuttle-run Test handgrip dynamometry TKK 5101 tightening D Tokyo Japan standing feet jump Test Abdominal Test trunk extension test and body mass index BMI was calculated Motor fitness was assessed by coordinations Test für Kinder - KTK To assess food consumption a 24-hour recall was held For statistical analysis the t-Student test and General Linear Model GLM - ANCOVA for repeated measures test with post-hoc Bonferroni p 005 were performed Multilinear regressions were done to analyse associations between measured outcomes
Detailed Description:
Study design
This quasi-experimental pilot study is part of a research study called ACTION FOR HEALTH Adolescents and Children in a Training InterventiON FOR HEALTH developed with youth of both gender 7-15 year-olds It is a multicomponent intervention program to promote PA classes and nutrition education and based on the behavior change Ecological Model This information is hypothesis of the study
ACTION FOR HEALTH study was approved by the Ethics Committee of the Center of Health Sciences of Federal University of Paraíba- Brazil UFPB The parents of the participants signed out a consent term
Study sample The project was announced in public and private schools of João Pessoa Brazil as well as through print newspapers and electronic social network media 59 youth volunteered and 43 children and adolescents 7-13 year-olds met the eligibility criteria 8 of them did not complete all the study protocol
So 35 comprised the sample and did all the evaluation protocol Participants were divided in two groups the intervention group INT n 17 7 boys who attended at least 75 of PA classes and met more than 50 of food goals and the control one CONT n 18 6 boys with a minimum or less than 49 attendance in PA classes and were not involved in the nutrition education program
Methodologies study and preparation of the intervention The program was developed by 4 teachers 7 graduate students 1 nutritionist 2 graduate Nutrition students and 1 cardiologist and participated in weekly meetings where methodologies and intervention sessions were prepared and tested During this test period activities that would promote greater adherence of students were listed Additionally participants randomly used a heart rate monitor Polar Team2 Pro Polar Finland and an accelerometer Actigraph GT3X model in order to record activities that promoted more significant increases in heart rate and in moderate and vigorous PA intensities
Physical exercise intervention The exercise sessions took 90 minutes in order to assure at least 60 minutes of physical exercise during 12 weeks The sessions were always taught by the same staff and were composed of 10 minutes of warm-up 30 minutes of circuit training 15-minute of pre-sports and recreational gamesand 5 minutes resting activities
Warm-up included aerobicanaerobic and recreational activities The circuit divided into 6 stations included activities that prioritized conditional andor coordinative physical capacities accordingly with the purpose of the proposed session for the day so that participants could maintain a high intensity throughout the circuit
In the first month the duration of each circuit station was 30 seconds which was increased to 45 seconds and 60 seconds in the second and third month respectively The transition time between each station was kept in 30 seconds throughout the intervention Finally low-heart rate activities were carried out with games to music and stretching
The intensity of the training sessions was defined in a heart rate HR average over 65 of maximum heart rate of each participant
Nutritional education intervention The dietary intervention designed by the nutritionist staff consisted of two actions The first was trough monthly events throughout the intervention one in the beginning of each month with participation of participants parents The second action consisted on the achievement of 3 dietary goals an easy an average and hard goal to which children and adolescents should meet during the months of intervention These goals were added during the intervention so that the beginning of the 1st month of intervention participants had three goals to meet and at the beginning of the 3rd month 9 goals They also received a worksheet to record if they met the minimum 1 star average 2 stars and maximum 3 stars of the daily goal
Parental support Simultaneously exercise sessions were offered to parents in order to encourage family participation in the intervention performed with children and adolescents The activities were carried out by a volunteer PA teacher in the center of sports of UFPB
Study variables Sexual maturation Each participant self-assessed their own stage of secondary sexual characteristics breast development stage in women and pubic hair in males TANNER 1962 The correlation between self-assessment of sexual maturity state and evaluation performed by the parent was 78 for female and 90 male This variable was used as confounder in the statistical procedures
Anthropometric measure Height determined by a stadiometer Holtain followed the standard procedure of Lohman 1988 Two measurements were performed recorded in meters to the nearest millimeter and was considered the arithmetic mean of the two measurements Body composition was measured after 4-hour-fasting and low water intake and then a bioimpedance scale was used Inbody 720 Biospace Co Ltd to determine body weight and fat mass
Metabolic variables Blood samples from the participants were collected after a nocturnal 12 hour-fasting by laboratory specialists through peripheral puncture in the cubital vein The analysis of CT HDL-C triglyceride and glucose was carried out by spectrophotometry Cobas Integra 400 Plus with Roche kits The LDL-C fraction was indirectly calculated using the Friedewald formula 1972 The aspartate aminotransferase AST and alanine aminotransferase ALT levels were determined by enzyme kinetic assay for spectrophotometrically obtained after centrifugation 10 minutes 3500 rpm Insulin was determined by Luminex-100 IS Integrated System Luminex Corporation Austin TX USA using the Linco Human Gut Hormone panel kit Linco Research Inc MO USA The insulin resistance was determined by HOMA-IR
Physical activity and sedentary behavior PA was measured by accelerometer Actigraph GT3X model Florida The participants used an accelerometer for 10 consecutive days and they also received instructions for the correct use of the device At the time of explanation and visual demonstration of the proper use of the device participants received a list of instructions along with a diary of activities in which they were required to record wear and non-wear time of the instrument and also habitual physical activities
Data reduction was performed by Actlife software version 6117 For the validation data at least 4 days of recording at least 8 hours per day 480 minutes day were considered 40 Of these 4 days 2 days corresponded to the intervention and 2 without intervention 1 weekend day The time of non-use was estimated based on periods of more than 20 consecutive minutes of zero For data download 15 seconds epochs were performed based on recommendations to similar populations The useful and non-time has been determined according to Troiano 2007 The cutoff points for determining the time spent on different intensities of PA followed the standards proposed by Evenson et al 2008 To determine time spent for physical activity week in each of the intensities was necessary to perform a calculation to generate weighted averages in minutes day of PA intensities Time spent in moderate-to-vigorous physical activity corresponded to the sum of moderate physical activity AFM and vigorous physical activity AFV values
Health related Physical Fitness Health related Physical Fitness components were evaluated from different tests of Fitnessgram battery test 1999 and ALPHA battery test which those protocols were performed internationally for similar populations Thus cardiorespiratory fitness CRF was measured using the test-run Suttle 20 m The test was complete when the participant failed to reach the final lines simultaneously with the audio signals on two consecutive occasions or when it ended the test due to fatigue
Muscle strength of upper limbs was measured by handgrip dynamometer with adjustable pinch TKK 5101 Grip D Takey Tokyo Japan which was conducted twice on each hand and recorded the maximum score achieved in kilograms For analysis it was calculated a mean value between the measurements of each hand Muscle strength of the lower limbs was assessed by Jumping test with feet together The participant leaped forward as much as possible on a stable non-slip surface The test was performed twice and the best score was recorded in centimeters Abdominal strength and endurance were measured by repetitions of abdominal test when the participant had to perform a maximum possible number of sit-ups up to a maximum of 75 for one minute
Trunk strength and flexibility were assessed by trunk extension test There were performed two attempts and validated the best one Flexibility of the lower limbs was assessed by sit-and-reach test and were performed two attempts for each leg and used the average value between the two attempts for each leg Body composition was measured by body mass index BMI calculated using the formula weight height 2 Motor fitness was evaluated by Koordinations Test für Kinder Tests - KTK battery of tests which is recommended for evaluation of motor components such as balance coordination speed and agility in children
Food consumption Food consumption was carried out by a 24-hour recall Participants along with their parents informed food consumption during the past two weekdays and one weekend day before evaluation Data from the three days were tabulated in the software Virtual Nutri to calculate the total energy consumption values for each of the three days For analytical procedures it calculated the average caloric intake among the three measurements
This quasi-experimental pilot study is part of a research study called ACTION FOR HEALTH Adolescents and Children in a Training InterventiON FOR HEALTH developed with youth of both gender 7-15 year-olds It is a multicomponent intervention program to promote PA classes and nutrition education and based on the behavior change Ecological Model This information is hypothesis of the study
ACTION FOR HEALTH study was approved by the Ethics Committee of the Center of Health Sciences of Federal University of Paraíba- Brazil UFPB The parents of the participants signed out a consent term
Study sample The project was announced in public and private schools of João Pessoa Brazil as well as through print newspapers and electronic social network media 59 youth volunteered and 43 children and adolescents 7-13 year-olds met the eligibility criteria 8 of them did not complete all the study protocol
So 35 comprised the sample and did all the evaluation protocol Participants were divided in two groups the intervention group INT n 17 7 boys who attended at least 75 of PA classes and met more than 50 of food goals and the control one CONT n 18 6 boys with a minimum or less than 49 attendance in PA classes and were not involved in the nutrition education program
Methodologies study and preparation of the intervention The program was developed by 4 teachers 7 graduate students 1 nutritionist 2 graduate Nutrition students and 1 cardiologist and participated in weekly meetings where methodologies and intervention sessions were prepared and tested During this test period activities that would promote greater adherence of students were listed Additionally participants randomly used a heart rate monitor Polar Team2 Pro Polar Finland and an accelerometer Actigraph GT3X model in order to record activities that promoted more significant increases in heart rate and in moderate and vigorous PA intensities
Physical exercise intervention The exercise sessions took 90 minutes in order to assure at least 60 minutes of physical exercise during 12 weeks The sessions were always taught by the same staff and were composed of 10 minutes of warm-up 30 minutes of circuit training 15-minute of pre-sports and recreational gamesand 5 minutes resting activities
Warm-up included aerobicanaerobic and recreational activities The circuit divided into 6 stations included activities that prioritized conditional andor coordinative physical capacities accordingly with the purpose of the proposed session for the day so that participants could maintain a high intensity throughout the circuit
In the first month the duration of each circuit station was 30 seconds which was increased to 45 seconds and 60 seconds in the second and third month respectively The transition time between each station was kept in 30 seconds throughout the intervention Finally low-heart rate activities were carried out with games to music and stretching
The intensity of the training sessions was defined in a heart rate HR average over 65 of maximum heart rate of each participant
Nutritional education intervention The dietary intervention designed by the nutritionist staff consisted of two actions The first was trough monthly events throughout the intervention one in the beginning of each month with participation of participants parents The second action consisted on the achievement of 3 dietary goals an easy an average and hard goal to which children and adolescents should meet during the months of intervention These goals were added during the intervention so that the beginning of the 1st month of intervention participants had three goals to meet and at the beginning of the 3rd month 9 goals They also received a worksheet to record if they met the minimum 1 star average 2 stars and maximum 3 stars of the daily goal
Parental support Simultaneously exercise sessions were offered to parents in order to encourage family participation in the intervention performed with children and adolescents The activities were carried out by a volunteer PA teacher in the center of sports of UFPB
Study variables Sexual maturation Each participant self-assessed their own stage of secondary sexual characteristics breast development stage in women and pubic hair in males TANNER 1962 The correlation between self-assessment of sexual maturity state and evaluation performed by the parent was 78 for female and 90 male This variable was used as confounder in the statistical procedures
Anthropometric measure Height determined by a stadiometer Holtain followed the standard procedure of Lohman 1988 Two measurements were performed recorded in meters to the nearest millimeter and was considered the arithmetic mean of the two measurements Body composition was measured after 4-hour-fasting and low water intake and then a bioimpedance scale was used Inbody 720 Biospace Co Ltd to determine body weight and fat mass
Metabolic variables Blood samples from the participants were collected after a nocturnal 12 hour-fasting by laboratory specialists through peripheral puncture in the cubital vein The analysis of CT HDL-C triglyceride and glucose was carried out by spectrophotometry Cobas Integra 400 Plus with Roche kits The LDL-C fraction was indirectly calculated using the Friedewald formula 1972 The aspartate aminotransferase AST and alanine aminotransferase ALT levels were determined by enzyme kinetic assay for spectrophotometrically obtained after centrifugation 10 minutes 3500 rpm Insulin was determined by Luminex-100 IS Integrated System Luminex Corporation Austin TX USA using the Linco Human Gut Hormone panel kit Linco Research Inc MO USA The insulin resistance was determined by HOMA-IR
Physical activity and sedentary behavior PA was measured by accelerometer Actigraph GT3X model Florida The participants used an accelerometer for 10 consecutive days and they also received instructions for the correct use of the device At the time of explanation and visual demonstration of the proper use of the device participants received a list of instructions along with a diary of activities in which they were required to record wear and non-wear time of the instrument and also habitual physical activities
Data reduction was performed by Actlife software version 6117 For the validation data at least 4 days of recording at least 8 hours per day 480 minutes day were considered 40 Of these 4 days 2 days corresponded to the intervention and 2 without intervention 1 weekend day The time of non-use was estimated based on periods of more than 20 consecutive minutes of zero For data download 15 seconds epochs were performed based on recommendations to similar populations The useful and non-time has been determined according to Troiano 2007 The cutoff points for determining the time spent on different intensities of PA followed the standards proposed by Evenson et al 2008 To determine time spent for physical activity week in each of the intensities was necessary to perform a calculation to generate weighted averages in minutes day of PA intensities Time spent in moderate-to-vigorous physical activity corresponded to the sum of moderate physical activity AFM and vigorous physical activity AFV values
Health related Physical Fitness Health related Physical Fitness components were evaluated from different tests of Fitnessgram battery test 1999 and ALPHA battery test which those protocols were performed internationally for similar populations Thus cardiorespiratory fitness CRF was measured using the test-run Suttle 20 m The test was complete when the participant failed to reach the final lines simultaneously with the audio signals on two consecutive occasions or when it ended the test due to fatigue
Muscle strength of upper limbs was measured by handgrip dynamometer with adjustable pinch TKK 5101 Grip D Takey Tokyo Japan which was conducted twice on each hand and recorded the maximum score achieved in kilograms For analysis it was calculated a mean value between the measurements of each hand Muscle strength of the lower limbs was assessed by Jumping test with feet together The participant leaped forward as much as possible on a stable non-slip surface The test was performed twice and the best score was recorded in centimeters Abdominal strength and endurance were measured by repetitions of abdominal test when the participant had to perform a maximum possible number of sit-ups up to a maximum of 75 for one minute
Trunk strength and flexibility were assessed by trunk extension test There were performed two attempts and validated the best one Flexibility of the lower limbs was assessed by sit-and-reach test and were performed two attempts for each leg and used the average value between the two attempts for each leg Body composition was measured by body mass index BMI calculated using the formula weight height 2 Motor fitness was evaluated by Koordinations Test für Kinder Tests - KTK battery of tests which is recommended for evaluation of motor components such as balance coordination speed and agility in children
Food consumption Food consumption was carried out by a 24-hour recall Participants along with their parents informed food consumption during the past two weekdays and one weekend day before evaluation Data from the three days were tabulated in the software Virtual Nutri to calculate the total energy consumption values for each of the three days For analytical procedures it calculated the average caloric intake among the three measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None