Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431997
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-23
Brief Title:
A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations a Randomized Controlled Study
Status:
NOT_YET_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:
This is a randomized controlled trial aiming to investigate whether a time-restricted eating TRE can reduce the incidence of gestational diabetes mellitus GDM in high-risk pregnant women Investigators intend to conduct a 3-month randomized controlled study to compare the effects of 10-hour TRE and habitual eating time on GDM under the same energy intake
Detailed Description:
Investigators present a multicenter open-label and parallel-group randomized study Total 240 women in early pregnancy were randomly assigned to TRE group and SOC standard of care group according to the ratio of 1 1 Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window from 830 am to 1830 pm each day and only noncaloric beverages were permitted outside of the eating window over 3 months from 14-26 gestational weeks Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months All participants should follow moderate-intensity physical activity for about 30 minutes every day and receive diet and exercise counseling during the study period GDM was diagnosed by 75g oral glucose tolerance test OGTT test at 24-28 gestational weeks
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