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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02932202
Acronym
WEIGHT
Enrollment
0
Registered
2016-10-13
Start date
2016-07-08
Completion date
2017-05-17
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Pregnancy, Weight Gain

Keywords

Obesity, Pregnancy, Weight Gain

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.

Interventions

OTHERLongitudinal Nutritional Counseling
OTHERStandard Care

Sponsors

Loyola University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of excessive weight gainAt time of deliveryTo 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.

Secondary

MeasureTime frameDescription
Healthy Eating HabitsAt time of deliveryTo 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)
Pregnancy ComorbidityAt time of deliveryTo 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026