Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337708
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-01-29
Brief Title:
Smart Walk A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
Official Title:
Smart Walk An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test a culturally tailored smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women
Detailed Description:
This study addresses major public health concerns among African American women physical inactivity and cardiometabolic disease risk
African American women experience a high burden of cardiometabolic diseases including heart disease obesity and type 2 diabetes Regular aerobic physical activity is an established behavior to prevent and treat these conditions Yet the many African American women are insufficiently active with only 27-40 meeting national aerobic physical activity guidelines
This study will test the efficacy of Smart Walk a culturally tailored theory-based smartphone-delivered intervention designed to increase physical activity and improve cardiometabolic disease risk factors among African American women In a 12-month trial participants will be randomly assigned to either the Smart Walk intervention or a Fitbit-only comparison arm for an active 4-month intervention period followed by an 8-month minimal contact follow-up period
Specific Aims
1 Test the effects of Smart Walk to increase physical activity and promote adherence to national aerobic physical activity guidelines compared to Fitbit-only comparison group
2 Test the effects of Smart Walk to improve cardiometabolic risk factors compared to Fitbit-only comparison group
3 Compare cost and cost effectiveness of the two intervention groups from a societal perspective
4 Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes
African American women experience a high burden of cardiometabolic diseases including heart disease obesity and type 2 diabetes Regular aerobic physical activity is an established behavior to prevent and treat these conditions Yet the many African American women are insufficiently active with only 27-40 meeting national aerobic physical activity guidelines
This study will test the efficacy of Smart Walk a culturally tailored theory-based smartphone-delivered intervention designed to increase physical activity and improve cardiometabolic disease risk factors among African American women In a 12-month trial participants will be randomly assigned to either the Smart Walk intervention or a Fitbit-only comparison arm for an active 4-month intervention period followed by an 8-month minimal contact follow-up period
Specific Aims
1 Test the effects of Smart Walk to increase physical activity and promote adherence to national aerobic physical activity guidelines compared to Fitbit-only comparison group
2 Test the effects of Smart Walk to improve cardiometabolic risk factors compared to Fitbit-only comparison group
3 Compare cost and cost effectiveness of the two intervention groups from a societal perspective
4 Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL168170 | NIH | None | httpsreporternihgovquickSearchR01HL168170 |