Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595056
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens Chicas Fuertes 2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens Chicas Fuertes 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test a physical activity intervention for Latina teenagers Investigators will recruit 200 Latina adolescents who are currently under-active to participate in this 12-month study Participants will be referred to the study by their primary care provider Half of the participants will be randomly selected for the Intervention group and will receive an individual counseling session and access to a personalized website These participants will also receive a Fitbit activity tracker to help with goal setting and monitoring plus weekly text messages and access to the study Instagram account to remind participants to be physically active Those assigned to the control group will receive the Fitbit activity tracker
Detailed Description:
This study will conduct a randomized trial to evaluate the efficacy of a theory-based individually tailored multi-technology intervention on increasing physical activity in Latina adolescents compared to a control group receiving only a physical activity tracker a Fitbit The study team will recruit adolescent age 13-17 Latinas N200 who are currently under-active to participate in the 12-month trial Those randomized to the Intervention arm will receive a one-on-one counseling session and access to an individually tailored multi-media website Key intervention components will be reinforced through text messaging to aid goal setting a physical activity tracker Fitbit to set goals track and log activity and access to a study Instagram account to reinforce exposure to web content The primary outcome will be increases in moderate-to-vigorous activity between baseline and 6 months Secondary outcomes will include changes in activity at 12 months potential mediators of the intervention costs of delivering the intervention behavior change trajectories from continuous data from Fitbits potential moderators and changes in physiological and psychological variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None