Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03473145
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2018-03-14
Brief Title:
Sedentary Behavior Interrupted Randomized Controlled Trial P2
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Sedentary Behavior Interrupted A Randomized Trial of 3-month Effects on Biomarkers of Healthy Aging and Physical Functioning in the Real World Project 2
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
Epidemiological findings indicate that older adults do not meet physical activity PA guidelines spend up to 11 hrsday sitting Given the high prevalence of sedentary behavior SB the higher chronic disease risk in this population the age-associated challenges of meeting traditional PA guidelines involving longer bouts of moderate PA the investigators hypothesize that older adult health will benefit from new strategies to interrupt sitting This protocol Sedentary Behavior Interrupted A randomized trial of 3-month effects on biomarkers of healthy aging and physical functioning in the real world Project 2 is part of a National Institutes of Aging Program Grant called Sedentary Time Aging Mortality and Physical Function STAR The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women This protocol also referred to Project 2 of the STAR program is a 3-arm randomized control trial designed to assess ways of interrupting sitting in 405 overweight postmenopausal women
Detailed Description:
Primary Aims
In our primary biomarker outcomes of glucose regulation fasting insulin glucose HbA1c HOMA-IR blood pressure BP
1 Investigate the 12 week effects of increased standing and additional brief sit-to-stand compared to attention controls
2 Investigate the dose-response effects of behavioral change on the biomarkers BP
Secondary aims
1 Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on physical emotional cognitive functioning
2 Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on in vivo skeletal muscle mitochondrial function
Exploratory aims
1 Explore the possible modifying effect of age on the relationship between intervention conditions primary secondary outcomes
2 Explore the psychosocial environmental mediators moderators of changes in sitting time standing time and transitions
3 Explore differences in outcomes between the 2 sitting interruption conditions
In our primary biomarker outcomes of glucose regulation fasting insulin glucose HbA1c HOMA-IR blood pressure BP
1 Investigate the 12 week effects of increased standing and additional brief sit-to-stand compared to attention controls
2 Investigate the dose-response effects of behavioral change on the biomarkers BP
Secondary aims
1 Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on physical emotional cognitive functioning
2 Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on in vivo skeletal muscle mitochondrial function
Exploratory aims
1 Explore the possible modifying effect of age on the relationship between intervention conditions primary secondary outcomes
2 Explore the psychosocial environmental mediators moderators of changes in sitting time standing time and transitions
3 Explore differences in outcomes between the 2 sitting interruption conditions
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