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Randomized Controlled Trial of a Physical Activity Program for Teenagers (FIT-TEEN)

4 september 2019 uppdaterad av: Semra Ozdemir, Duke-NUS Graduate Medical School

Randomized Controlled Trial of a Physical Activity Program for Teenagers (FIT-TEEN)

The study aims:

  1. To test the effect of providing social comparison information on increasing physical activity among Singaporean adolescents.
  2. To test whether providing social comparison information increases physical activity more when it is provided publicly compared to when it is provided anonymously.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Childhood and adolescent obesity represents a major public health challenge worldwide. Singapore is no exception as the prevalence of obesity among children was estimated at 12%. Overweight and obese children are more likely to become obese adults, to develop non-communicable diseases at a younger age, and to have a shorter life expectancy. One of the main reasons behind the growing obesity epidemic is low levels of physical activity. Previous literature shows evidence of a steep decline in physical activity among boys after the primary school years and low levels of activity among girls throughout the primary and high school years in Singapore. Daily step counts are found to be up to 35% short of the recommended daily steps for adolescents. Low levels of physical activity are also associated with lower psychological well-being among adolescents. Thus, it is important that interventions aimed at increasing physical activity target adolescent years.

In this study, the investigators propose to test the effectiveness of providing social comparison information on increasing physical activity among adolescents. Participating adolescents will be randomized into a group and groups will be randomized into one of two study arms in a 4-month walking program:

Private arm: At the end of each week, participants will be provided with the number of steps logged by the participants in their group. The number of steps will be ranked from highest to the lowest without any identifiable information about the participants.

Public arm: At the end of each week, participants in this arm will be provided with the same information as in the other arm plus the names of the participants corresponding to the number of steps logged.

Social comparison information will be provided to the study participants via SMS. We will conduct a 4-month two-arm RCT to test whether social comparison information increases physical activity more when it is disclosed publicly compared to when it is provided anonymously. The primary outcome is the average number of steps taken per week by participants. Study outcomes relating to physical activity and health-related quality of life for participants will be evaluated at baseline and 4 months. Step activity will be tracked in real time via Fitbit wireless pedometers throughout the study.

Studietyp

Interventionell

Inskrivning (Faktisk)

311

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Singapore, Singapore, 169857
        • Duke-NUS Medical School

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år till 16 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • The study's target population is adolescents aged 13-16 years. Participants should be Singaporean citizens or permanent residents. Participants should be English-speaking. Participants should be willing to wear a pedometer for 4 months. Only participants who provide at least 8 (out of 14 days) valid days of pedometer data including at least 2 days of the weekend at baseline will be included.

Exclusion Criteria:

  • Participants will be asked to complete a short screener questionnaire to ensure that they are healthy enough to participate. Participants reporting the following will be excluded:
  • Having any medical condition that may limit their ability to walk as a means of physical activity
  • Are unwilling to wear a wireless pedometer for 4 months

Participants will also be screened with a Physical Activity Readiness Questionnaire (PAR-Q). Those who answer 'YES' to any PAR-Q question will be permitted to enroll only if they provide written approval from a medical doctor.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Private Arm
At the end of each week, participants will be provided with the number of steps logged by the participants in their group. The number of steps will be ranked from highest to the lowest without any identifiable information about the participants.
Social comparison information will be provided to the study participants weekly via SMS
Fitbit is a wireless pedometer that tracks steps of participants and will be offered in conjunction with a tailored website with customised information for participants.
Andra namn:
  • Fitbit Flex, wireless pedometer, physical activity tracker
Experimentell: Public Arm
At the end of each week, participants will be provided with the number of steps logged by the participants in their group. The number of steps will be ranked from highest to the lowest with the full names of the participants corresponding to the number of steps.
Social comparison information will be provided to the study participants weekly via SMS
Fitbit is a wireless pedometer that tracks steps of participants and will be offered in conjunction with a tailored website with customised information for participants.
Andra namn:
  • Fitbit Flex, wireless pedometer, physical activity tracker

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The average number of steps taken per week by participants
Tidsram: 4 months
These will be assessed through Fitbit pedometers at baseline and at the last 2 weeks of the trial. All participants will be issued a step counter, the Fitbit Flex™ for use during the entire 4-month RCT.
4 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Health Outcomes: Quality of life index
Tidsram: 4 months
The quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) for adolescents. These measures will be taken twice; at baseline and at the end of the study.
4 months
Health Outcomes: Depression
Tidsram: 4 months
Depression will be measured using Asian Adolescent Depression Scale (AADS) which is validated for Singaporean adolescents.These measures will be taken twice; at baseline and at the end of the study.
4 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Semra Ozdemir, PhD, Duke-NUS Graduate Medical School

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 december 2016

Primärt slutförande (Faktisk)

1 augusti 2018

Avslutad studie (Faktisk)

1 december 2018

Studieregistreringsdatum

Först inskickad

9 mars 2017

Först inskickad som uppfyllde QC-kriterierna

9 mars 2017

Första postat (Faktisk)

15 mars 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 september 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 september 2019

Senast verifierad

1 september 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • HSRNIG13nov007

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Upon request from the principal investigator, individual participant data will be available to other researchers for secondary analysis purposes, such as meta-analyses, reanalysis or replication of results. Any data that will be shared will be de-identified so privacy of the participants will be protected.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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