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Trial record 2 of 2 for:    23415616 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03081013
Recruitment Status : Active, not recruiting
First Posted : March 15, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Semra Ozdemir, Duke-NUS Graduate Medical School

Brief 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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Social information Device: Fitbit Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial of a Physical Activity Program for Teenagers (FIT-TEEN)
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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.
Other Name: Fitbit Flex, wireless pedometer, physical activity tracker

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.
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.
Other Name: Fitbit Flex, wireless pedometer, physical activity tracker




Primary Outcome Measures :
  1. The average number of steps taken per week by participants [ Time Frame: 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.


Secondary Outcome Measures :
  1. Health Outcomes: Quality of life index [ Time Frame: 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.

  2. Health Outcomes: Depression [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081013


Locations
Singapore
Duke-NUS Medical School
Singapore, Singapore, 169857
Sponsors and Collaborators
Duke-NUS Graduate Medical School
Investigators
Principal Investigator: Semra Ozdemir, PhD Duke-NUS Medical School

Additional Information:
Publications:

Responsible Party: Semra Ozdemir, Assistant Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT03081013     History of Changes
Other Study ID Numbers: HSRNIG13nov007
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Semra Ozdemir, Duke-NUS Graduate Medical School:
adolescents
social norms