Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy Trial

Obesity Clinical Trial

— WEIGHT  

Official title:

Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy (WEIGHT) Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02932202
• Other study ID #: 208756
• Status: Withdrawn
• Phase: N/A
• First received: October 10, 2016
• Last updated: May 31, 2017
• Start date: July 8, 2016
• Est. completion date: May 17, 2017

Study information

• Verified date: May 2017
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.· 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 17, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnancy identified less than 15 week 0 days gestational age

• Body mass index greater then or equal to 18

Exclusion Criteria:

• Multiple gestation

• Pre-pregnancy diabetes mellitus

• HIV

Related Conditions & MeSH terms

• Obesity
• Pregnancy
• Weight Gain

Intervention

Other:
• Longitudinal Nutritional Counseling

• Standard Care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

References & Publications (2)

Asbee SM, Jenkins TR, Butler JR, White J, Elliot M, Rutledge A. Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):305-12. doi: 10.1097/AOG.0b013e318195baef. — View Citation

Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of excessive weight gain	To compare the effect of a medical student assisted program of nutritional counseling and web based nutrition tracking to standard of care on the incidence of excessive weight gain in pregnancy based on the Institute of Medicine's guidelines.	At time of delivery
Secondary	Healthy Eating Habits	To characterize how a medical student assisted program of nutritional counselling and web based nutrition tracking affects perception of healthy eating habits (e.g servings of dairy, vegetables, protein, healthy meals)	At time of delivery
Secondary	Pregnancy Comorbidity	To compare the incidence of maternal outcomes including gestational diabetes, gestational hypertension and preeclampsia for patients receiving nutrition counselling and web based nutrition tracking compared to standard of care controls	At time of delivery