Randomized Controlled Trial of a Physical Activity Program for Teenagers (FIT-TEEN)
4 de septiembre de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
311
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Singapore, Singapur, 169857
- Duke-NUS Medical School
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
13 años a 16 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
Otros nombres:
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Experimental: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The average number of steps taken per week by participants
Periodo de tiempo: 4 months
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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.
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4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Health Outcomes: Quality of life index
Periodo de tiempo: 4 months
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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.
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4 months
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Health Outcomes: Depression
Periodo de tiempo: 4 months
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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.
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4 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Semra Ozdemir, PhD, Duke-NUS Graduate Medical School
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de diciembre de 2016
Finalización primaria (Actual)
1 de agosto de 2018
Finalización del estudio (Actual)
1 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
9 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
9 de marzo de 2017
Publicado por primera vez (Actual)
15 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de septiembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
4 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HSRNIG13nov007
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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