Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372860
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-04
Brief Title:
DPP Feasibility Study of Breastfeeding - eMOMS 20
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Diabetes Prevention Program Feasibility Study of Breastfeeding - Electronic Monitoring of Moms Schedule 20
Status:
RECRUITING
Status Verified Date:
2024-05
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 investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program DPP on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity This intervention named eMOMS is delivered by a certified health coach via a mobile health mHealth application
Detailed Description:
This study is a randomized controlled trial designed to determine the feasibility and efficacy of a combined breastfeeding diabetes prevention-based program DPP in a cohort of overweight or obese women to be followed during pregnancy through 3 months postpartum The trial will have two study arms DPP breastfeeding Tx1 and Usual Care Tx2
Aim 1 Quantify interest in use of the DPP-lactation mobile health mHealth application among target population To accomplish this we will 1 measure research engagement including rates of screening recruitment and retention among users especially rural and raciallyethnically diverse women 2 assess barriersfacilitators to enrollmentretention through surveys and semi-structured in-depth interviews or focus groups and 3 evaluate intervention uptake delivery and adherence via trackingmeasuring use of the mHealth app
Aim 2 Measure weight loss and duration of lactation through 3 months postpartum among target population To accomplish this we will measure pre-pregnancy weight weight at study entry weight immediately prior to and after delivery and weight at specific postpartum time points Lactation and infant feeding practices will be measured at similar postpartum time points
Aim 1 Quantify interest in use of the DPP-lactation mobile health mHealth application among target population To accomplish this we will 1 measure research engagement including rates of screening recruitment and retention among users especially rural and raciallyethnically diverse women 2 assess barriersfacilitators to enrollmentretention through surveys and semi-structured in-depth interviews or focus groups and 3 evaluate intervention uptake delivery and adherence via trackingmeasuring use of the mHealth app
Aim 2 Measure weight loss and duration of lactation through 3 months postpartum among target population To accomplish this we will measure pre-pregnancy weight weight at study entry weight immediately prior to and after delivery and weight at specific postpartum time points Lactation and infant feeding practices will be measured at similar postpartum time points
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 |
|---|---|---|---|
| 3P20GM144269-02S2 | NIH | None | httpsreporternihgovquickSearch3P20GM144269-02S2 |