Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women
NCT00740766 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 257
Last updated 2009-06-08
Summary
The aim of this prospective randomized study is the prevention of excessive weight gain in obese pregnant women. The study will compare perinatal outcomes of obese pregnant women treated in the traditional way to outcomes of nutritionally monitored obese pregnant women and evaluate a preliminary behavioral model applicable to the general practice of obstetrics.
Conditions
Interventions
- BEHAVIORAL
-
Food diary and behavioral model
The monitored group is to be placed on a prenatal nutritional program consisting of 18 to 24 kcal. per kg. (according to the patient's actual weight) with monitoring each visit. The patients will be weighed each prenatal visit with the monitored patients weighed and blinded to their actual weight (being weighed with her back to the scale). The monitored patients will be requested not to weigh at home and all patients will be asked to wear similar clothing at each visit. All intervention (monitored) group women will be asked to record in a diary all of the foods eaten during each day. These records will be reviewed at each prenatal visit. Six weeks after delivery, the patient will be weighed and will then exit the study. The food diary notebooks will be collected from each patient at the end of the study.
Sponsors & Collaborators
-
Jamaica Hospital Medical Center
lead OTHER
Principal Investigators
-
Yvonne S Thornton, MD, MPH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 1998-06-30
- Primary Completion
- 2005-05-31
- Completion
- 2005-05-31
Countries
- United States
Study Locations
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