Effect of a Multicomponent Intervention in Children and Adolescents

NCT02929472 | Completed

• 1 other identifier: IM-AF-RM
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Physical Activity; Metabolic Diseases

Keywords

Physical Activity; Physical Fitness; Intervention; Children and Adolescents

Outcome Measures

Primary Outcomes (7)

• cardiorespiratory fitness

  Shuttle-run Test 20m - participants ran between two lines 20m away, keeping the rhythm corresponding to the audio signals from a prerecorded CD. The initial speed was 8.5km / h and increased 0.5km / h every minute (one minute corresponds to one stage). Participants were instructed to run in a straight line, at their own pace, and returning at the end of each beep. The test was completed 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. The procedure was done previously described by Leger et al (1988).

  3-months

• Muscle strength of the upper limbs

  Pinch manual - using a manual dynamometer with adjustable pinch (TKK 5101 Grip D; Takey, Tokyo Japan). The participant held a gradual and continuous hold for at least two seconds, with the right and left hand, with the elbow in full extension as standard procedure described above (CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC). NATIONAL CENTER FOR HEALTH STATISTICS ( NCHS), 2011). The test was conducted twice on each hand and recorded the maximum score achieved in kilograms. For analysis it computed the average value between the measurements of each hand.

  3-months

• muscle strength of the lower limbs:

  jump test with feet together - from an initial position with your feet parallel, immediately behind a line drawn on the ground, the participant leaped forward as much as possible, on a hard, non-slip surface. The test was performed twice and the best score was recorded in centimeters.

  3-months

• Abdominal endurance:

  Test repetitions of abdominal - was to make the largest possible number of sit-ups, up to a maximum of 75 for one minute. Lying on a mattress with your knees bent, arms straight, palms face down and his head resting on the mattress. a banner was placed with a width of 11.5 cm, under the performer's knees. This track was used to determine the route to be traveled by sliding your hands on the mattress.

  3-months

• Flexibility of the trunk:

  trunk extension test - consisted of starting from the prone position, with legs and outstretched arms and hands under the thighs, raise trunk controllably up to a maximum of 30 cm (measured between your chin and the mattress). There were two attempts and validated the best of them.

  3-months

• Flexibility of the lower limbs:

  Test sit and reach - was to achieve the greatest distance possible with your hands, one over the other, with the participant barefoot, with the left leg bent and the other with the foot flat on the measuring bench. There were two attempts for each leg and used the average value between the two attempts for each leg.

  3-months

• Body composition:

  body mass index (BMI) - was calculated using the formula (weight / height) 2.

  3-months

Secondary Outcomes (5)

• Cholesterol Markers

  3-months

• Hepatic markers

  3-months

• Insulin

  3-months

• Triglycerides

  3-months

• Glucose

  3-months

Study Arms (2)

Physical Exercise

EXPERIMENTAL

The intervention group (INT, n = 17, 7 boys) who attended at least 75% of PA classes and met more than 50% of food goals.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.

Behavioral: Physical exercise

without physical exercise

OTHER

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.

Behavioral: without physical exercise

Interventions

Physical exercise BEHAVIORAL

The intervention group (INT, n = 17, 7 boys) who attended at least 75% of PA classes and met more than 50% of food goals.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.

Physical Exercise

without physical exercise BEHAVIORAL

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.

without physical exercise

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• volunteered to participate in the study
• Excess weight / obesity for experimental group
• Aged 7 to 13 years

You may not qualify if:

• No complete evaluation protocol

Sponsors & Collaborators

• Clarice Maria de Lucena Martins: lead

MeSH Terms

Conditions

Motor Activity; Metabolic Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor PhD

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 11, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 11, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share