A Physical Activity Program for Adolescents - ActTeens

NCT05070377 | Completed

• 1 other identifier: ActTeens
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the ActTeens (Active teens) Program to improve the physical activity level, physical fitness, cardiometabolic and mental health in adolescents. The investigators hypothesize that that intervention group participant's fitness and physical activity levels will improve during this period in comparison with control group participants.

Conditions

Healthy

Keywords

Active Behavior; Muscular Fitness; Cardiorespiratory fitness; Metabolic profile; Well-being; ill-being; Teens

Outcome Measures

Primary Outcomes (1)

• Change from baseline in physical activity at week 24

  Adolescents will be instructed to wear an Actigraph (GT3X) accelerometer on the hip at the height of the anterior iliac spine for all day (except when bathing, swimming, sleeping) for a period of seven consecutive days. The subjects who use at least wear time of \>8 h on 3 days or more (including 1 weekend) will be included in the valid analyses data. The time (minutes/day) spent in physical activity of different light, moderate and vigorous intensities will be estimated, using validated cut off points. Non-wear time, defined as ≥60 min of continuous '0' counts, will be removed from the dataset. Weekday and weekend days physical activity will be calculated separately (i.e., mean minutes per day).

  Baseline and week 24

Secondary Outcomes (13)

• Change from baseline in cardiometabolic health at week 24

  Baseline and week 24

• Change from baseline in insulin at week 24

  Baseline and week 24

• Change from baseline in muscular fitness at week 24

  Baseline and week 24

• Change from baseline in cardiorespiratory fitness at week 24

  Baseline and week 24

• Change from baseline in anxiety, depression and stress symptoms on the Depression and Anxiety Stress Scale-short form (DASS 21) at week 24

  Baseline and week 24

Study Arms (2)

Intervention

EXPERIMENTAL

The ActTeens Program will include interventions in three different context: (1) structured physical activity sessions by physical education (school), (2) self-monitoring plus goal setting by pedometer (out-of-school), and (3) healthy lifestyle guidance (social support). The structured PA will be developed in PE lessons, twice a week, with twenty-minute each lesson (40 min·week) To promote active behavior out-of-school will be used a pedometer plus goals setting where each adolescent of the intervention group will receive their own goal (based on the number of steps measured in the baseline week) outlining the goals to achieve weekly. To improve healthy behavior will be sent by WhatsApp® messages about healthy eating and regular PA for the intervention and parents groups.

Other: Physical activity

Control

NO INTERVENTION

The control group participated in usual practice (regularly scheduled PE and postcurricular school sport) for the duration of the study .

Interventions

Physical activity OTHER

1. structured physical activity sessions by physical education (school), twice a week, with twenty-minute each lesson; 2. self-monitoring plus goal setting by pedometer (out-of-school), progressive goals to achieve weekly; 3. healthy lifestyle guidance ( parents social support).

Intervention

Eligibility Criteria

• Age: 13 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Schools: secondary public schools in Jacarezinho city, including students from 13 - 14 years (i.e., Grade 8 and 9); physical education lessons on alternate days.
• Teacher: Two grades 8 and 9 (one each year) teachers per school that agree to participate in the program during the scheduled class time;
• Eligible Adolescents are grade 8 or 9 students with age between 13-14 years whose the parents or legal guardians accept and sign the informed consent authorization the use of their data.

You may not qualify if:

• Students with the cardiometabolic disease diagnosed (type 2 diabetes; hypertension) and with a physical or mental condition that would preclude their participation in physical activity program will be excluded from the study (analysis), but will still participate in normal lessons.

Sponsors & Collaborators

• Antonio Stabelini Neto: lead

Study Sites (1)

Universidade Estadual do Norte do Paraná

Jacarezinho, Paraná, 864000-000, Brazil

Location

Related Publications (1)

• Stabelini Neto A, Santos GCD, Silva JMD, Correa RC, da Mata LBF, Barbosa RO, Zampier Ulbrich A, Kennedy SG, Lubans DR. Improving physical activity behaviors, physical fitness, cardiometabolic and mental health in adolescents - ActTeens Program: A protocol for a randomized controlled trial. PLoS One. 2022 Aug 9;17(8):e0272629. doi: 10.1371/journal.pone.0272629. eCollection 2022.

  PMID: 35944003 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

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

Study Officials

• Antonio Stabelini Neto, PhD

  Universidade Estadual do Norte do Parana

  STUDY CHAIR

• Géssika Castilho dos Santos, Ms

  Universidade Estadual de Londrina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 7, 2021
• Study Start: March 28, 2022
• Primary Completion: December 8, 2022
• Study Completion: May 28, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: At the end of the trial.
• Access Criteria: Approval of an analysis protocol by the study's steering committee

Locations

BR (1)