Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women
3 other identifiers
interventional
257
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jun 1998
Longer than P75 for not_applicable obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedJune 8, 2009
June 1, 2009
6.9 years
August 22, 2008
June 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean weight gain Proportion with excessive weight gain (greater than 15 pounds) Mean postpartum weight increment Newborn birthweight and length, controlled for gestational age Proportion of macrosomia Incidence of co-morbidities
From entry until 6-weeks postpartum
Study Arms (2)
Monitored
EXPERIMENTALUnmonitored
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- BMI greater than 29.9 kg/m2
- Single fetus
You may not qualify if:
- Diabetes
- Hypertension or chronic kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
St. Luke's-Roosevelt Hospital
New York, New York, 10025, United States
Jamaica Hospital Medical Center
New York, New York, 11418, United States
Related Publications (1)
Thornton YS, Smarkola C, Kopacz SM, Ishoof SB. Perinatal outcomes in nutritionally monitored obese pregnant women: a randomized clinical trial. J Natl Med Assoc. 2009 Jun;101(6):569-77. doi: 10.1016/s0027-9684(15)30942-1.
PMID: 19585925RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yvonne S Thornton, MD, MPH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 25, 2008
Study Start
June 1, 1998
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
June 8, 2009
Record last verified: 2009-06