Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523946
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Pacific Islander Physical Activity Project
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using Momentary Measures to Understand Physical Activity Adoption and Maintenance Among Pacific Islanders in the United States
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
PiPA
Brief Summary:
This proposed longitudinal study will examine the influences of neighborhood factors and momentary contextual and psychosocial factors which the investigators call acute precipitants on physical activity PA adoption and maintenance among Pacific Islanders PcIs Specifically the investigators will enroll 150 sedentary PcI adults and examine their PA adoption and maintenance based on measurements at five separate weeks during a 20-month period The investigators will use MotionSense an innovative and proven mHealth kit developed by team members Global Positioning System GPS and ecological momentary assessment to measure PA and its key determinants Our central hypotheses are that individual and neighborhood factors are associated with PA adoption and maintenance among previously sedentary PcIs and that psychosocial precipitants mediate these associations
Detailed Description:
Pacific Islanders PcIs one of the fastest growing racialethnic groups in the United States bear the highest obesity rate among all racialethnic groups in the United States and suffer from a disproportionate burden of health disparities in cardiovascular diseases diabetes and cancers PA is important for addressing these disparities because regular PA decreases obesity and reduces the risks of these diseases In general PcIs are less physically active than non-Hispanic Whites with the majority not meeting nationally-recommended PA levels However few studies have investigated the underlying mechanisms of PA behavior change for PcIs Recent research highlighted the importance of contextual social and built environments on PA participation among racialethnic minorities and the necessity of understanding psychosocial pathways to PA behaviors However research in this area has been significantly limited by the lack of data measured at micro timescales eg across minutes hours or days that can capture the dynamic interactions between contextual factors and PA behavior The paucity of research on PA behaviors among PcIs and the lack of micro timescale data for understanding PA mechanisms have hampered the search for effective policies and interventions to reduce PA-related health disparities for this high-risk population
Our long-term goal is to use mobile Health mHealth technologies to help PcIs increase their PA levels and thereby to reduce their health disparities This proposed longitudinal study will examine the influences of neighborhood factors and momentary contextual and psychosocial factors which the investigators call acute precipitants on PA adoption and maintenance among PcIs Specifically the investigators will enroll 150 sedentary PcI adults and examine their PA adoption and maintenance based on measurements at five separate weeks during a 20-month period The investigators will use MotionSense an innovative and proven mHealth kit developed by team members GPS and ecological momentary assessment to measure PA and its key determinants An innovation of this mHealth system is that it can continuously measure PA and contextual and psychosocial acute precipitants in natural environments therefore providing the much-needed micro timescale data for studying the dynamic nature of PA behavioral change Our preliminary studies have confirmed the feasibility of using this system to measure PA and PA correlates Our multidisciplinary team has expertise in PA behavior analysis PA intervention mHealth technologies geographical analysis and health psychology
Our central hypotheses are that individual and neighborhood factors are associated with PA adoption and maintenance among previously sedentary PcIs and that psychosocial precipitants mediate these associations The investigators have designed the following two aims to test these central hypotheses
Aim 1 To examine the influences of neighborhood factors on PA adoption and maintenance among sedentary PcI adults The investigators hypothesize that lower levels of PA adoption and maintenance are associated with disadvantageous neighborhood factors eg lack of access to PA facilities higher levels of poverty lower social cohesion after controlling for individual-level factors The investigators will first define PA adoption and maintenance based on the change of PA level across the five measurement weeks for each participant and then link them to neighborhood factors using linear mixed effects models
Aim 2 To determine the dynamic relationships between contextual and psychosocial acute precipitants and PA
2a The investigators hypothesize that lower frequency and duration of PA are associated with disadvantageous acute precipitants eg decreased access to PA facilities increased negative affect and decreased self-efficacy and the associations vary between stages of PA adoption and maintenance The investigators will use the micro timescale data measured by our mHealth system to construct PA indicators and acute precipitants Then an innovative dynamic prediction model will be used to investigate their temporal dynamic associations
2b The investigators hypothesize that psychosocial acute precipitants eg self-efficacy negative affect mediate the influence of contextual acute precipitants eg access to PA resources on PA should the investigators find any significant associations between the latter two
This is an observational study rather than an interventional study that contains a physical activity intervention The primary goal is not to evaluate the effectiveness of the PA intervention in increasing PA levels but how neighborhood and contextual factors influence PA adoption and maintenance The investigators use the PA intervention to stimulate PA engagement for all participants so that the investigators can observe their PA behavior change in a real-world setting
Since the purpose of the study is not to evaluate the effectiveness of the intervention it does not fulfill the third criterion of the NIH definition of clinical trials and should be considered an observational study
Our long-term goal is to use mobile Health mHealth technologies to help PcIs increase their PA levels and thereby to reduce their health disparities This proposed longitudinal study will examine the influences of neighborhood factors and momentary contextual and psychosocial factors which the investigators call acute precipitants on PA adoption and maintenance among PcIs Specifically the investigators will enroll 150 sedentary PcI adults and examine their PA adoption and maintenance based on measurements at five separate weeks during a 20-month period The investigators will use MotionSense an innovative and proven mHealth kit developed by team members GPS and ecological momentary assessment to measure PA and its key determinants An innovation of this mHealth system is that it can continuously measure PA and contextual and psychosocial acute precipitants in natural environments therefore providing the much-needed micro timescale data for studying the dynamic nature of PA behavioral change Our preliminary studies have confirmed the feasibility of using this system to measure PA and PA correlates Our multidisciplinary team has expertise in PA behavior analysis PA intervention mHealth technologies geographical analysis and health psychology
Our central hypotheses are that individual and neighborhood factors are associated with PA adoption and maintenance among previously sedentary PcIs and that psychosocial precipitants mediate these associations The investigators have designed the following two aims to test these central hypotheses
Aim 1 To examine the influences of neighborhood factors on PA adoption and maintenance among sedentary PcI adults The investigators hypothesize that lower levels of PA adoption and maintenance are associated with disadvantageous neighborhood factors eg lack of access to PA facilities higher levels of poverty lower social cohesion after controlling for individual-level factors The investigators will first define PA adoption and maintenance based on the change of PA level across the five measurement weeks for each participant and then link them to neighborhood factors using linear mixed effects models
Aim 2 To determine the dynamic relationships between contextual and psychosocial acute precipitants and PA
2a The investigators hypothesize that lower frequency and duration of PA are associated with disadvantageous acute precipitants eg decreased access to PA facilities increased negative affect and decreased self-efficacy and the associations vary between stages of PA adoption and maintenance The investigators will use the micro timescale data measured by our mHealth system to construct PA indicators and acute precipitants Then an innovative dynamic prediction model will be used to investigate their temporal dynamic associations
2b The investigators hypothesize that psychosocial acute precipitants eg self-efficacy negative affect mediate the influence of contextual acute precipitants eg access to PA resources on PA should the investigators find any significant associations between the latter two
This is an observational study rather than an interventional study that contains a physical activity intervention The primary goal is not to evaluate the effectiveness of the PA intervention in increasing PA levels but how neighborhood and contextual factors influence PA adoption and maintenance The investigators use the PA intervention to stimulate PA engagement for all participants so that the investigators can observe their PA behavior change in a real-world setting
Since the purpose of the study is not to evaluate the effectiveness of the intervention it does not fulfill the third criterion of the NIH definition of clinical trials and should be considered an observational study
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