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

Not Applicable

Terminated

• Conditions: Obesity; Pregnancy
• Interventions: Behavioral: Dietary and lifestyle counseling

• Registration Number: NCT00792480
• Lead Sponsor: Carolinas Medical Center

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.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2008-11
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-17
• Last Update Submitted: 2008-11-17
• Study First Posted: 2008-11-18
• Last Update Posted: 2008-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Establish prenatal care at 6 - 16 weeks gestation
2. 18-49 years of age
3. Receive their entire prenatal care at the Resident Obstetrics Clinic
4. English and/or Spanish speaking
5. Singleton gestation.

Exclusion Criteria

1. Establish prenatal care >16 weeks gestation
2. Non-English or non-Spanish speaking
3. Multiple gestation pregnancy
4. BMI > 40
5. Preexisting diabetes, untreated thyroid disease, or hypertension requiring medication or other medical conditions that might affect body weight
6. Delivery at institution other than CMC-Main
7. Pregnancy ending in a premature delivery (< 37 weeks)
8. Limited prenatal care (<4 visits)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Counseling Group	Dietary and lifestyle counseling	-

Primary Outcome Measures

Name	Time	Method
The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.	3 - 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States