Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868954
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-24
First Post:
2023-05-11
Brief Title:
Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Implementation of a Mediterranean Diet Program for Overweight or Obese Pregnant Women in a Low-resource Clinical Setting
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
MedDiet
Brief Summary:
The purpose of this research is to compare two healthy diet styles during pregnancy Sixty pregnant women between 8 and 16 weeks will participate Participates will be randomly assigned like flipping a coin to either receive routine healthy diet advice and counseling or to receive advice and counseling for the Mediterranean style diet Our current routine healthy diet program follows the recommendations provided by the American College of Obstetricians and Gynecologists ACOG It recommends the consumption of grains fruits vegetables protein foods and dairy foods during pregnancy The Mediterranean diet MedDiet is a well-known healthy diet that consists of a large amount of plant-based foods such as fruits vegetables beans and nuts with olive oil as the principal source of fat Dairy fish and poultry are consumed in moderation and red meat only eaten occasionally Throughout their pregnancy participants will receive free food and be assessed to determine how will they are following to the diet plan they were randomized to
Detailed Description:
The Mediterranean diet MedDiet is a well-known healthy diet that consists of a large amount of plant-based foods such as fruits vegetables beans and nuts with extra virgin olive oil EVOO as the principal source of fat Dairy fish and poultry are consumed in moderation and red meat only eaten occasionally A growing body of evidence demonstrates that outside of pregnancy the MedDiet is associated with a reduction of cardiovascular disease diabetes metabolic syndrome and certain cancers However the potential clinical benefits of MedDiet in pregnancy are understudied with most data originating from clinical trials in Europe Proper nutrition during pregnancy has multiple health benefits A mother eating a healthy diet has a higher probability of meeting the demands required for a normal fetal development In addition she is more likely to achieve the recommended gestational weight gain thereby reducing the risk of pregnancy-related complications Finally a healthy diet is associated with a reduction of chronic conditions such as cardiovascular disease and diabetes later in life for both the mother and the infant
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