Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491537
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-01
Brief Title:
Time-restricted Eating for Postpartum Weight Loss
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Time4Mom
Brief Summary:
This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweightobesity
Detailed Description:
Existing postpartum weight retention PPWR interventions have had limited success Timing-based interventions such as early time-restricted eating eTRE show significant improvements in cardiometabolic endpoints in non-postpartum cohorts The purpose of the Time4Mom study is to conduct a pilot randomized trial of a postpartum-adapted eTRE intervention to test feasibility and acceptability of the eTRE intervention and trial protocol We will also compare changes in clinical outcomes of interest and patient-reported outcomes between eTRE intervention and control groups
This 2-arm trial will randomize 60 postpartum women to either Control or eTRE for 12 weeks n30group
This 2-arm trial will randomize 60 postpartum women to either Control or eTRE for 12 weeks n30group
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 |
|---|---|---|---|
| K23HD108345 | NIH | None | None |