Randomized Controlled Trial of a Physical Activity Program for Teenagers (FIT-TEEN)
4 settembre 2019 aggiornato da: Semra Ozdemir, Duke-NUS Graduate Medical School
Randomized Controlled Trial of a Physical Activity Program for Teenagers (FIT-TEEN)
The study aims:
- To test the effect of providing social comparison information on increasing physical activity among Singaporean adolescents.
- To test whether providing social comparison information increases physical activity more when it is provided publicly compared to when it is provided anonymously.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
311
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Singapore, Singapore, 169857
- Duke-NUS Medical School
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 13 anni a 16 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The average number of steps taken per week by participants
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Health Outcomes: Quality of life index
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Semra Ozdemir, PhD, Duke-NUS Graduate Medical School
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Saunders RP, Pate RR, Felton G, Dowda M, Weinrich MC, Ward DS, Parsons MA, Baranowski T. Development of questionnaires to measure psychosocial influences on children's physical activity. Prev Med. 1997 Mar-Apr;26(2):241-7. doi: 10.1006/pmed.1996.0134.
- Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
- Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- Neighbors C, Larimer ME, Lewis MA. Targeting misperceptions of descriptive drinking norms: efficacy of a computer-delivered personalized normative feedback intervention. J Consult Clin Psychol. 2004 Jun;72(3):434-47. doi: 10.1037/0022-006X.72.3.434.
- Tudor-Locke C, Johnson WD, Katzmarzyk PT. Accelerometer-determined steps per day in US children and youth. Med Sci Sports Exerc. 2010 Dec;42(12):2244-50. doi: 10.1249/MSS.0b013e3181e32d7f.
- Must A, Strauss RS. Risks and consequences of childhood and adolescent obesity. Int J Obes Relat Metab Disord. 1999 Mar;23 Suppl 2:S2-11. doi: 10.1038/sj.ijo.0800852.
- Chia M. Pedometer-assessed physical activity of Singaporean youths. Prev Med. 2010 May-Jun;50(5-6):262-4. doi: 10.1016/j.ypmed.2010.03.004. Epub 2010 Mar 11.
- Lee KS, Trost SG. Validity and reliability of the 3-day physical activity recall in Singaporean adolescents. Res Q Exerc Sport. 2005 Mar;76(1):101-6. doi: 10.1080/02701367.2005.10599265. No abstract available.
- Kirkcaldy BD, Shephard RJ, Siefen RG. The relationship between physical activity and self-image and problem behaviour among adolescents. Soc Psychiatry Psychiatr Epidemiol. 2002 Nov;37(11):544-50. doi: 10.1007/s00127-002-0554-7.
- Sallis JF, Prochaska JJ, Taylor WC. A review of correlates of physical activity of children and adolescents. Med Sci Sports Exerc. 2000 May;32(5):963-75. doi: 10.1097/00005768-200005000-00014.
- Maturo CC, Cunningham SA. Influence of friends on children's physical activity: a review. Am J Public Health. 2013 Jul;103(7):e23-38. doi: 10.2105/AJPH.2013.301366. Epub 2013 May 16.
- Donaldson SI, Graham JW, Hansen WB. Testing the generalizability of intervening mechanism theories: understanding the effects of adolescent drug use prevention interventions. J Behav Med. 1994 Apr;17(2):195-216. doi: 10.1007/BF01858105.
- Larimer ME, Neighbors C. Normative misperception and the impact of descriptive and injunctive norms on college student gambling. Psychol Addict Behav. 2003 Sep;17(3):235-43. doi: 10.1037/0893-164X.17.3.235.
- Schultz PW, Nolan JM, Cialdini RB, Goldstein NJ, Griskevicius V. The constructive, destructive, and reconstructive power of social norms. Psychol Sci. 2007 May;18(5):429-34. doi: 10.1111/j.1467-9280.2007.01917.x.
- Yun D, Silk KJ. Social norms, self-identity, and attention to social comparison information in the context of exercise and healthy diet behavior. Health Commun. 2011 Apr;26(3):275-85. doi: 10.1080/10410236.2010.549814.
- Tudor-Locke C, Craig CL, Beets MW, Belton S, Cardon GM, Duncan S, Hatano Y, Lubans DR, Olds TS, Raustorp A, Rowe DA, Spence JC, Tanaka S, Blair SN. How many steps/day are enough? for children and adolescents. Int J Behav Nutr Phys Act. 2011 Jul 28;8:78. doi: 10.1186/1479-5868-8-78.
- Finkelstein EA, Tan YT, Malhotra R, Lee CF, Goh SS, Saw SM. A cluster randomized controlled trial of an incentive-based outdoor physical activity program. J Pediatr. 2013 Jul;163(1):167-72.e1. doi: 10.1016/j.jpeds.2013.01.009. Epub 2013 Feb 14.
- Woo BS, Chang WC, Fung DS, Koh JB, Leong JS, Kee CH, Seah CK. Development and validation of a depression scale for Asian adolescents. J Adolesc. 2004 Dec;27(6):677-89. doi: 10.1016/j.adolescence.2003.12.004.
- Lee JJ, Nadkarni NV, Teo I, Ozdemir S. The Effect of Social Norm-based Intervention with Observable Behaviour on Physical Activity among Adolescents: A Randomized Controlled Trial. BMC Sports Sci Med Rehabil. 2020 Aug 31;12:52. doi: 10.1186/s13102-020-00202-y. eCollection 2020.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 dicembre 2016
Completamento primario (Effettivo)
1 agosto 2018
Completamento dello studio (Effettivo)
1 dicembre 2018
Date di iscrizione allo studio
Primo inviato
9 marzo 2017
Primo inviato che soddisfa i criteri di controllo qualità
9 marzo 2017
Primo Inserito (Effettivo)
15 marzo 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 settembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 settembre 2019
Ultimo verificato
1 settembre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- HSRNIG13nov007
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Social information
-
Stanford UniversityBill and Melinda Gates FoundationCompletatoBambino | Gravidanza | Infante | Nutrizione | Salute
-
University Hospital, LilleTerminatoMalattia di Alzheimer | PATTERN VARIANTE ELETTROENCEFALOGRAFICO 1 (Disturbo)Francia
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)CompletatoCancro al seno | Cancro colorettale | Cancro alla prostata | Cancro toracicoStati Uniti
-
Unity Health TorontoCanadian Institutes of Health Research (CIHR)Iscrizione su invitoCancro colorettale | Screening del cancroCanada
-
Karina Lopes DevitoIscrizione su invitoSocial media | Educazione dentale e processi di apprendimento dell'insegnamentoBrasile
-
Georgetown UniversityNational Institutes of Health (NIH)Reclutamento
-
University of California, Los AngelesBrown University; Asociación Civil Impacta Salud y Educación, Peru; The Fenway...Completato
-
University of California, San FranciscoNational Cancer Institute (NCI); HopeLab Foundation; Rescue AgencyReclutamentoDipendenza da nicotina | Svapare | Cessazione dello svapoStati Uniti
-
University of MichiganNational Institute on Drug Abuse (NIDA)CompletatoUso di cannabisStati Uniti
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletatoSovrappeso e obesitàStati Uniti