Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-17 @ 9:42 AM
Study NCT ID:
NCT02932202
Status:
WITHDRAWN
Last Update Posted:
2017-06-01
First Post:
2016-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy Trial
Sponsor:
Loyola University
Organization:
Study Overview
Official Title:
Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy (WEIGHT) Trial
Status:
WITHDRAWN
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was stopped due to no recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WEIGHT
Brief Summary:
Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counseling. The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.
Detailed Description:
Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. The rates of obesity in American adults is 34.9% and the rates of excessive weight gain in pregnancy for all women range from 20-40% with even higher rates seen in the obese. Such high rates are putting mothers and infants at significant risk.ยท In 2009, the Institute of Medicine outlined clear guidelines for suggested weight gain goals based on pre-pregnancy BMI. Currently only 30-40% of pregnant women are meeting the suggested weight gain goals and the great majority not meeting the goals are gaining excessive weight. However, despite the high prevalence of excessive weight gain, there is little access to insurance covered nutrition counselling. The standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counselling. This can be challenging due to limited time and resources. However, there is good evidence that diet intervention reduces the risk of excessive weight gain by up to 20%. If appropriate nutritional counselling were available to all patients, the rates of excessive weight gain could be significantly impacted and have widespread improvement in pregnancy outcomes. The CDC has made important progress in providing free nutrition resources online to all patients. This study aims to incorporate this free resource with a sustainable ongoing nutrition counselling to impact the rates of excessive weight gain in pregnancy.
The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.
The objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.
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?: