Access to Nutritional Services and the Effect on Maternal Weight Gain
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Purpose
The purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. There are many studies that have shown that obesity has a negative impact on pregnancy. However, currently there are only a few small studies that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on maternal weight gain and pregnancy outcomes. This study will compare two groups of pregnant women with a BMI of 30 or greater. The investigators hypothesize that access to nutritional services will lead to decreased weight gain during pregnancy and improved pregnancy outcomes.
| Condition | Intervention |
|---|---|
|
Pregnancy Obesity |
Behavioral: Nutritional Counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ease of Access to Nutritional Services and the Effect on Maternal Weight in an Obese Urban Population |
- Weight gain [ Time Frame: one year ] [ Designated as safety issue: No ]change in weight from baseline prepregnancy weight
- Birth weight [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]Weight of infant at the time of birth
- Fetal anomalies [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]Ultrasound findings of fetal anomalies or those detected at birth
- Hypertensive disease of pregnancy [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]Development of hypertensive disease during pregnancy
- Gestational diabetes [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]Development of gestational diabetes
- Neonatal intensive care admission [ Time Frame: 28 days ] [ Designated as safety issue: No ]Admission to neonatal intensive care unit
- APGAR scores [ Time Frame: At birth ] [ Designated as safety issue: No ]Measurement at birth
- Mode of delivery [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]vaginal delivery or cesarean section
- Intrauterine Fetal Demise [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]Death of fetus prior to delivery
- Neonatal Death [ Time Frame: 28 days ] [ Designated as safety issue: No ]Death of neonate from birth to 28 days of life
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Routine Obstetric Care | |
|
Experimental: Nutritional Counseling
Patients will receive an initial 90 minute nutritional consult followed by 60 minute follow up consults every 2 weeks to monitor weight gain and nutritional status.
|
Behavioral: Nutritional Counseling
Patients will keep a daily diary of nutritional intake as well as physical activity. They will also follow up with the nutritional counselor six weeks postpartum.
|
Detailed Description:
The purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. Approximately one fourth of women in the United States are overweight and nearly one third are considered to be obese. Pregnancy places obese women at increased risk for several adverse events in the antepartum, intrapartum, and postpartum period. There are many studies that have shown that obesity in pregnancy has a negative impact on pregnancy. However, currently there are few studies in the United States that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on pregnancy outcomes. This study will be a randomized controlled study that will compare two groups of pregnant women with a BMI of 30 or greater one of which has access to nutritional services along with routine prenatal care while the other gets only routine prenatal care. The investigators hypothesize that the obese parturient who has access to nutritional services will have decreased weight gain during pregnancy and ultimately have improved pregnancy outcomes. This will help to guide future care for the obese parturient in the urban population who may have limited access to services.
Eligibility| Ages Eligible for Study: | 19 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- primigravid women
- age 19-40yrs
- less than or equal to 18 weeks gestation at time of enrollment
- body mass index (BMI) greater than or equal to 30
Exclusion Criteria:
- multiparous women
- less than 19 yrs of age or older than 40
- greater than 18 weeks gestation at time of enrollment
- body mass index (BMI) less than 30
- any significant past medical history including hypertension, diabetes, renal disease, coagulopathy
- past surgical history of gastric bypass/weight loss surgery
Contacts and Locations| Contact: Erin M Murphy, MD | 215-481-4211 | emmurphy@amh.org |
| Contact: Bethany Perry, MD | 215-481-4211 | bperry@amh.org |
| United States, Pennsylvania | |
| Abington Memorial Hospital | Recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| Contact: Erin M Murphy, MD 215-481-4020 emmurphy@amh.org | |
| Contact: Bethany Perry, MD 215-481-4020 bperry@amh.org | |
| Principal Investigator: Erin M Murphy, MD | |
| Sub-Investigator: Bethany Perry, MD | |
| Abington Memorial Hospital | Recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| Principal Investigator: Erin M Murphy, MD | |
| Sub-Investigator: Bethany Perry, MD | |
| Principal Investigator: | Erin M Murphy, MD | Abington Memorial Hospital |
| Study Director: | Bethany Perry, MD | Abington Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Erin M. Murphy, MD, Principal Investigator, Abington Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01713712 History of Changes |
| Other Study ID Numbers: | 11-070 |
| Study First Received: | September 6, 2012 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Abington Memorial Hospital:
|
Pregnancy Obesity Nutrition therapy |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013