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

NCT02932202 | Withdrawn

• 1 other identifier: 208756
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Pregnancy; Weight Gain

Keywords

Obesity; Pregnancy; Weight Gain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Healthy Eating Habits

  At time of delivery

• Pregnancy Comorbidity

  At time of delivery

Study Arms (2)

Longitudinal Nutritional Counseling

EXPERIMENTAL

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

Other: Longitudinal Nutritional Counseling

Standard Care Counseling

PLACEBO COMPARATOR

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.

Other: Standard Care

Interventions

Longitudinal Nutritional Counseling OTHER

Longitudinal Nutritional Counseling

Standard Care OTHER

Standard Care Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy identified less than 15 week 0 days gestational age
• Body mass index greater then or equal to 18

You may not qualify if:

• Multiple gestation
• Pre-pregnancy diabetes mellitus
• HIV

Sponsors & Collaborators

• Loyola University: lead

Related Publications (2)

• 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.

  PMID: 24570244 BACKGROUND

• 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.

  PMID: 19155899 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Gain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Scott Graziano, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 13, 2016
• Study Start: July 8, 2016
• Primary Completion: May 17, 2017
• Study Completion: May 17, 2017
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share