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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2007

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.

Interventions

  • Behavioral: Dietary and lifestyle counseling
    • 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.

Arms, Groups and Cohorts

  • Experimental: Intensive Counseling Group
  • No Intervention: Routine care group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.
    • Time Frame: 3 – 6 months

Secondary Measures

  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Carolinas Medical Center
  • Provider of Information About this Clinical Study
    • Shelly Asbee, MD, PI, Lake Norman Ob/Gyn
  • Overall Official(s)
    • Shelly M Asbee, M.D., Principal Investigator, Lake Norman Ob/Gyn

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