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

Carolinas Medical Center100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Obesity Pregnancy

Interventions

Dietary and lifestyle counselingBEHAVIORAL

The intervention group will undergo a complete history and physical with attention to prepregnancy weight, current weight, height, and BMI. At the initial visit, they will meet with a registered dietician to receive a standardized counseling session, including information on pregnancy-specific dietary and lifestyle choices. The patient will be instructed to engage in moderate intensity exercise at least 3 times per week and preferably 5 times per week. They will also receive information on the appropriate weight gain during pregnancy using the IOM guidelines. Each subject will meet with the dietician only at the time of enrollment. At each routine obstetric appointment, the participant's weight will be measured and charted on an IOM Gestational Weight Gain Grid in front of the participant. The healthcare provider will inform the participant if her weight gain was at the appropriate level and counsel her accordingly regarding increasing or decreasing her intake and exercise.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Carolinas Medical Center

Charlotte, North Carolina, United States

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.

Time frame: 3 - 6 months

Data from ClinicalTrials.gov

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