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

NCT ID: NCT02932202

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-08
• Study Completion Date: 2017-05-17

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.

Conditions

Obesity; Pregnancy; Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Longitudinal Nutritional Counseling

The intervention group will be contacted every 2 weeks by medical students over the phone to provide nutrition counseling and complete a verbal survey. During the phone calls, participants will be asked a series of questions regarding their dietary intake over the course of the last 2 weeks. If any deficiencies are identified, participants will be counseled on those topics

Group Type: EXPERIMENTAL

Longitudinal Nutritional Counseling

Intervention Type: OTHER

Standard Care Counseling

Participants in the control group will receive standard counseling, which includes weights at every visit, and counseling on weight gain goals as perceived necessary by the provider.

Group Type: PLACEBO_COMPARATOR

Standard Care

Intervention Type: OTHER

Interventions

Longitudinal Nutritional Counseling

Intervention Type: OTHER

Standard Care

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Scott Graziano

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Graziano, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

References

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.

Reference Type: BACKGROUND

PMID: 24570244 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19155899 (View on PubMed)

Other Identifiers

208756

Identifier Type: -

Identifier Source: org_study_id