Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT04021602
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2019-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Diabetes Prevention Program Feasibility Study of Breastfeeding
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
Diabetes Prevention Program Feasibility Study of Breastfeeding
Status:
COMPLETED
Status Verified Date:
2025-01
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 learn about the impact of the Diabetes Prevention Program (DPP) coupled with intensive breastfeeding support to help overweight or obese pregnant women lose weight postpartum, improve their blood sugars and blood pressure, and increase duration of breastfeeding their infant.
Detailed Description:
This pilot randomized controlled trial seeks to determine the feasibility and efficacy of a combined breastfeeding, DPP-based program in a cohort of overweight/obese women to be followed during pregnancy through 6 months postpartum. The pilot trial will have three study arms: DPP + breastfeeding (Tx1), DPP only (Tx2), and usual care (Tx3). Specific aims are: 1) To test the efficacy of Tx1 to improve 6-month postpartum weight loss among women with a BMI \>/= 25. 2) To test the efficacy of Tx1 to improve 6-month postpartum mean blood glucose (HbA1c) and mean arterial blood pressure among women with a BMI \>/= 25. 3) To test the efficacy of Tx1 to increase any breastfeeding through 6 months postpartum among women with a BMI \>/= 25.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K01DK113048-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |