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

Carolinas Medical Center

Status: Terminated

Conditions: Obesity; Pregnancy

Treatments: Behavioral: Dietary and lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00792480

WIP 06-05-04A

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intensive Counseling Group

Experimental group

Treatment:

Behavioral: Dietary and lifestyle counseling

Routine care group

No Intervention group

Description:

The routine care group took part in an initial physical exam and history, routine labs, and routine visits per American College of Obstetrics \& Gynecology (ACOG) standards. The only counseling on diet and exercise during pregnancy was that included in our standard prenatal booklet "What to do When You're Having a Baby" by Gloria Mayer (Institute for Health Advancement, 2003, La Habra, CA). At each routine obstetric appointment, the participant's weight was measured recorded in the medical chart. The healthcare provider did not counsel the participant regarding any changes in diet or lifestyle.