Physical Activity Clinical Trial
Official title:
Effect of a Multicomponent Intervention on Physical Fitness and Metabolic Risk Markers in Children and Adolescents: A Pilot Study
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 education.The 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 <0.05) were performed. Multilinear regressions were done to analyse associations between measured outcomes.
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 games;and 5 minutes resting activities.
Warm-up included aerobic/anaerobic and recreational activities. The circuit, divided into 6
stations, included activities that prioritized conditional and/or 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 6.11.7. 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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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