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

NCT ID: NCT00792480

Last Updated: 2008-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-04-30

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.

Conditions

Obesity; Pregnancy

Keywords

Obesity; Pregnancy; Exercise; Nutrition; obesity in pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intensive Counseling Group

Group Type: EXPERIMENTAL

Dietary and lifestyle counseling

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Carolinas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lake Norman Ob/Gyn

Principal Investigators

Shelly M Asbee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lake Norman Ob/Gyn

Locations

Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 19155899 (View on PubMed)

Other Identifiers

WIP 06-05-04A

Identifier Type: -

Identifier Source: org_study_id