Clinical trial NCT00792480: Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial
Official title: Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Pregnancy
Keywords: Obesity
Pregnancy
Exercise
Nutrition
obesity in pregnancy
Lead sponsor: Carolinas Medical Center
Sponsor class: OTHER
First posted: 2008-11-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.
timeFrame: 3 - 6 months
Secondary outcomes:
measure: 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.
timeFrame: 3 - 6 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Lake Norman Ob/Gyn
name: Shelly M Asbee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.