Randomized Controlled Trial of a Physical Activity Program for Teenagers

Physical Activity Clinical Trial

— FIT-TEEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081013
• Other study ID #: HSRNIG13nov007
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2019
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Social information
Social comparison information will be provided to the study participants weekly via SMS

Device:
• Fitbit
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.

Locations

Country	Name	City	State
Singapore	Duke-NUS Medical School	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

References & Publications (17)

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average number of steps taken per week by participants	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
Secondary	Health Outcomes: Quality of life index	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
Secondary	Health Outcomes: Depression	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

External Links

•   Active for Life - Physical Activity: some is better than none." Health Promotion Board Singapore (HPB).
•   Global recommendations on physical activity for health." World Health Organization (WHO), 2010.
•   S'pore experts on the perils of childhood obesity and how to avert it." AsiaOne, 19 April 2014.