Clinical trial NCT02932202: Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy Trial
Official title: Women Eating With Interactive Tracking to Gain Healthily Through Term Pregnancy (WEIGHT) Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Pregnancy
Weight Gain
Keywords: Obesity
Pregnancy
Weight Gain
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to either a medical student assisted program comprising nutritional counselling and web based nutrition tracking methods (i.e., longitudinal nutritional counseling program) or routine follow-up with their primary healthcare specialist (standard of care) using a 1:1 random numbers block allocation
Primary purpose: TREATMENT

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.· 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of excessive weight gain
timeFrame: At time of delivery
Secondary outcomes:
measure: Healthy Eating Habits
timeFrame: At time of delivery
measure: Pregnancy Comorbidity
timeFrame: At time of delivery
Other outcomes:
Locations:
Study officials:
affiliation: Loyola University
name: Scott Graziano, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.