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

Obesity Clinical Trial

— WIP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00792480
• Other study ID #: WIP 06-05-04A
• Status: Terminated
• Phase: N/A
• First received: November 14, 2008
• Last updated: November 17, 2008
• Start date: October 2005
• Est. completion date: April 2007

Study information

• Verified date: November 2008
• Source: Carolinas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Pregnancy
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Carolinas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.		3 - 6 months	No
Secondary	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.		3 - 6 months	No