Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335056
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-28
First Post:
2024-02-26
Brief Title:
Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools
Sponsor:
Louisiana State University and AM College
Organization:
Louisiana State University and AM College
Study Overview
Official Title:
Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools
Status:
ENROLLING_BY_INVITATION
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:
ProudMe
Brief Summary:
This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe The study recruits 480 adolescents from 12 middle schools cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation fidelity reach penetration and sustainability with manageable time and financial cost
Detailed Description:
The Louisiana-based 12-week multi-level multi-component ecological intervention is called Preventing Obesity Using Digital-assisted Movement and Eating ProudMe Guided by robust theories and prior work this project involves multiple trained student researchers to address two specific aims
Aim 1 to test the effectiveness of the ProudMe intervention in Louisiana middle schools Informed by power analysis 80 statistical power the study recruits 480 adolescents from 12 middle schools cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools Quantitative data on obesity-prevention behaviors ie physical activity screen-based sedentary behavior diet behaviors and weight status ie body mass index z score waist circumference are collected from all adolescent participants using validated instruments and procedures The investigators hypothesize the multi-level modeling analyses to show improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to a waist-list control after controlling for sociodemographic factors at multiple ecological levels
Aim 2 to test the implementation outcomes of the ProudMe intervention in Louisiana middle schools The investigators collect mixed-methods data from 24 school implementers ie teachers administrators and staff 96 adolescents and 96 parents at the 6 ProudMe schools to capture adaptation and implementation indicators The investigators evaluate the adaptations made across three phases early mid late of the implementation ie what at what level when how why by whom and impact to intervention In addition the investigators assess reach fidelity penetration sustainability and cost of the implementation across early mid and late phases of the implementation The investigators expect the ProudMe schools to show appropriate levels of adaptation fidelity reach penetration and sustainability with manageable time and financial cost
Building on previously funded work eg R21HD090513 PI Dr Chen this project is led by a strong collaborative transdisciplinary team with experts from kinesiology developmental psychology nutrition childhood obesity computer science statistics and implementation science The project significantly strengthens the research environment of the Louisiana State University LSU - a primarily undergraduate student serving institution under-funded by the NIH The project creates unique opportunities that are otherwise unavailable for LSU students who aspire to seek advanced education or careers in biomedical and health fields
Aim 1 to test the effectiveness of the ProudMe intervention in Louisiana middle schools Informed by power analysis 80 statistical power the study recruits 480 adolescents from 12 middle schools cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools Quantitative data on obesity-prevention behaviors ie physical activity screen-based sedentary behavior diet behaviors and weight status ie body mass index z score waist circumference are collected from all adolescent participants using validated instruments and procedures The investigators hypothesize the multi-level modeling analyses to show improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to a waist-list control after controlling for sociodemographic factors at multiple ecological levels
Aim 2 to test the implementation outcomes of the ProudMe intervention in Louisiana middle schools The investigators collect mixed-methods data from 24 school implementers ie teachers administrators and staff 96 adolescents and 96 parents at the 6 ProudMe schools to capture adaptation and implementation indicators The investigators evaluate the adaptations made across three phases early mid late of the implementation ie what at what level when how why by whom and impact to intervention In addition the investigators assess reach fidelity penetration sustainability and cost of the implementation across early mid and late phases of the implementation The investigators expect the ProudMe schools to show appropriate levels of adaptation fidelity reach penetration and sustainability with manageable time and financial cost
Building on previously funded work eg R21HD090513 PI Dr Chen this project is led by a strong collaborative transdisciplinary team with experts from kinesiology developmental psychology nutrition childhood obesity computer science statistics and implementation science The project significantly strengthens the research environment of the Louisiana State University LSU - a primarily undergraduate student serving institution under-funded by the NIH The project creates unique opportunities that are otherwise unavailable for LSU students who aspire to seek advanced education or careers in biomedical and health fields
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 |
|---|---|---|---|
| 1R15HD108765-01A1 | NIH | None | httpsreporternihgovquickSearch1R15HD108765-01A1 |