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

This study has been terminated.
(Resident research project limited by restrictions of residency program.)
Sponsor:
Information provided by:
Carolinas Medical Center
ClinicalTrials.gov Identifier:
NCT00792480
First received: November 14, 2008
Last updated: November 17, 2008
Last verified: November 2008
  Purpose

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


Condition Intervention
Obesity
Pregnancy
Behavioral: Dietary and lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Carolinas Medical Center:

Primary Outcome Measures:
  • The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive Counseling Group 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.

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.

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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792480

Locations
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Medical Center
Investigators
Principal Investigator: Shelly M Asbee, M.D. Lake Norman Ob/Gyn
  More Information

No publications provided by Carolinas Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shelly Asbee, MD, PI, Lake Norman Ob/Gyn
ClinicalTrials.gov Identifier: NCT00792480     History of Changes
Other Study ID Numbers: WIP 06-05-04A
Study First Received: November 14, 2008
Last Updated: November 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Medical Center:
Obesity
Pregnancy
Exercise
Nutrition
obesity in pregnancy

Additional relevant MeSH terms:
Obesity
Weight Gain
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 15, 2014