ObesityNCT00740766
Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women
A study testing Food diary and behavioral model in people with Obesity, run by Jamaica Hospital Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Food diary and behavioral model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 1998to May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- BMI greater than 29.9 kg/m2
- Single fetus
Who cannot join
- Diabetes
- Hypertension or chronic kidney disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Morristown Memorial Hospital
Morristown, New Jersey, 07962
St. Luke's-Roosevelt Hospital
New York, New York, 10025
Jamaica Hospital Medical Center
New York, New York, 11418
About this study
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.
Read the detailed description
Study Population and Selection:
This study will recruit 200 obese pregnant women at 12 to 28 weeks of gestation with a body mass index (BMI) of greater than 29.9 kg/m2. Women will be eligible if they are pregnant with a single fetus, and are free of diabetes, hypertension, or chronic kidney disease at recruitment.
Methodology:
The patients will be randomized to either traditional or monitored groups. All participants will be counseled at least once regarding conventional prenatal nutrition guidelines. A more detailed dietary intake protocol would be done with the intervention (monitored) group, which would include being placed on a balanced nutritional intake regimen of 18-24 kcal/kg/day (no less than 2000 calories). Each patient will be asked to record in a diary all of the foods she eats during the day, which will be reviewed by the investigator or assignee at each prenatal visit. The patients will be weighed at each prenatal visit with the monitored patients weighed and blinded to their actual weight.
Data analysis:
The two groups will be compared with respect to pregnancy weight gain, proportion of excessive weight gain (greater than 15 pounds), maternal morbidity, intrapartum complications and newborn birthweight. The primary analysis will consist of a two sample t-test comparing the monitored versus non-monitored groups with regard to weight gain at delivery. A secondary analysis using a repeated measures ANOVA will look at weight gain in the two groups from baseline to 6 weeks post partum in order to look at trends over time. Tests of mean contrasts will compare differences between the two groups at each time during and post pregnancy relative to baseline. Additional analyses will be done to look at other outcomes. In the case of continuous variable outcomes (e.g., gestational weight), a student's t-test will be used. while for categorical outcomes (e.g., macrosomia), the chi square test will be used for the comparison. Alpha will be 0.05 for each comparison.
- Conditions
- Obesity
- Being tested
- Food diary and behavioral model
- Keywords
- Perinatal Outcomes, Obesity, Pregnant women
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food diary and behavioral modelBehavioural
Also called Adherence to prenatal nutritional program
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.
| Study group | Role | What they receive |
|---|---|---|
| Monitored | Experimental | Not described Receives: Behavioral: Food diary and behavioral model |
| Unmonitored | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From entry until 6-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJun 1998
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamaica Hospital Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Yvonne S Thornton, MD, MPH, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740766
- Sponsor's protocol ID
- IRB#02-017
- Other IDs
- MMH IRB#R98-05-022, SLRHC IRB#01-138
- Status last verified
- Jun 2009
- First submitted
- 22 Aug 2008
- Last updated
- 8 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19585925
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT00740766
- Acronym / sponsor ID
- IRB#02-017
- Conditions
- Obesity
- Keywords
- Perinatal Outcomes, Obesity, Pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Jamaica Hospital Medical CenterUniversity, hospital or other
- Study start
- Jun 1998
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Population and Selection:
This study will recruit 200 obese pregnant women at 12 to 28 weeks of gestation with a body mass index (BMI) of greater than 29.9 kg/m2. Women will be eligible if they are pregnant with a single fetus, and are free of diabetes, hypertension, or chronic kidney disease at recruitment.
Methodology:
The patients will be randomized to either traditional or monitored groups. All participants will be counseled at least once regarding conventional prenatal nutrition guidelines. A more detailed dietary intake protocol would be done with the intervention (monitored) group, which would include being placed on a balanced nutritional intake regimen of 18-24 kcal/kg/day (no less than 2000 calories). Each patient will be asked to record in a diary all of the foods she eats during the day, which will be reviewed by the investigator or assignee at each prenatal visit. The patients will be weighed at each prenatal visit with the monitored patients weighed and blinded to their actual weight.
Data analysis:
The two groups will be compared with respect to pregnancy weight gain, proportion of excessive weight gain (greater than 15 pounds), maternal morbidity, intrapartum complications and newborn birthweight. The primary analysis will consist of a two sample t-test comparing the monitored versus non-monitored groups with regard to weight gain at delivery. A secondary analysis using a repeated measures ANOVA will look at weight gain in the two groups from baseline to 6 weeks post partum in order to look at trends over time. Tests of mean contrasts will compare differences between the two groups at each time during and post pregnancy relative to baseline. Additional analyses will be done to look at other outcomes. In the case of continuous variable outcomes (e.g., gestational weight), a student's t-test will be used. while for categorical outcomes (e.g., macrosomia), the chi square test will be used for the comparison. Alpha will be 0.05 for each comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitored | Experimental | Behavioral: Food diary and behavioral model |
| Unmonitored | No intervention | – |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- BMI greater than 29.9 kg/m2
- Single fetus
Key exclusion criteria (2 listed)
- Diabetes
- Hypertension or chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food diary and behavioral modelAlso: Adherence to prenatal nutritional programThe 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. | Behavioural | Monitored |
Primary outcome
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
Time frame: From entry until 6-weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2009.
- Results publication: PubMed 19585925Thornton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne S Thornton, MD, MPH principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food diary and behavioral model in people with Obesity, run by Jamaica Hospital Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From entry until 6-weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2009.