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Clinical Trials/NCT00792480
NCT00792480
Terminated
Not Applicable

Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial

Carolinas Medical Center1 site in 1 country100 target enrollmentOctober 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Carolinas Medical Center
Enrollment
100
Locations
1
Primary Endpoint
The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.
Status
Terminated
Last Updated
17 years ago

Overview

Brief Summary

The purpose of this study is to determine if an organized, consistent program of dietary and lifestyle counseling will prevent excessive gestational weight gain.

Detailed Description

Excessive gestational weight gain is common with about one third of women gaining more weight in pregnancy than is recommended. Unfortunately, the prevalence of excessive gestational weight gain is increasing. Gestational weight gain greater than that recommended by the Institute of Medicine (IOM) is associated with increased risk of gestational complications (hypertension, diabetes, and preeclampsia), infant macrosomia, and complications in delivery including increased risk of cesarean delivery. Currently, there is no evidence-based prenatal counseling protocol available to prevent excessive gestational weight gain. We hypothesize that consistent counseling on appropriate pregnancy diet, weight gain, and the potential complications of excessive gestational weight gain will result in fewer women gaining above the IOM recommendations.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
April 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Carolinas Medical Center

Eligibility Criteria

Inclusion Criteria

  • Establish prenatal care at 6 - 16 weeks gestation
  • 18-49 years of age
  • Receive their entire prenatal care at the Resident Obstetrics Clinic
  • English and/or Spanish speaking
  • Singleton gestation.

Exclusion Criteria

  • Establish prenatal care \>16 weeks gestation
  • Non-English or non-Spanish speaking
  • Multiple gestation pregnancy
  • Preexisting diabetes, untreated thyroid disease, or hypertension requiring medication or other medical conditions that might affect body weight
  • Delivery at institution other than CMC-Main
  • Pregnancy ending in a premature delivery (\< 37 weeks)
  • Limited prenatal care (\<4 visits)

Outcomes

Primary Outcomes

The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.

Time Frame: 3 - 6 months

Secondary Outcomes

  • The investigators secondary outcomes will include the effect of weight gain on mode of delivery, rate of operative vaginal delivery, infant weight, and the incidence of preeclampsia, GDM, vaginal/perineal lacerations, and shoulder dystocia.(3 - 6 months)

Study Sites (1)

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