- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03081013
Randomized Controlled Trial of a Physical Activity Program for Teenagers (FIT-TEEN)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Singapore, Singapore, 169857
- Duke-NUS Medical School
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
Andre navn:
|
Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The average number of steps taken per week by participants
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Health Outcomes: Quality of life index
Tidsramme: 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.
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4 months
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Health Outcomes: Depression
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Semra Ozdemir, PhD, Duke-NUS Graduate Medical School
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- HSRNIG13nov007
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