PregnancyNCT01713712
Access to Nutritional Services and the Effect on Maternal Weight Gain
A study testing Nutritional Counseling in people with Pregnancy and Obesity, run by Abington Memorial Hospital at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- What is being tested?
- Nutritional Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Feb 2014
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Erin M Murphy, MD, 215-481-4020, emmurphy@amh.org
Bethany Perry, MD, 215-481-4020, bperry@amh.org
- Recruiting
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Erin M Murphy, MD
Bethany Perry, MD
About this study
Official title: Ease of Access to Nutritional Services and the Effect on Maternal Weight in an Obese Urban Population
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.
Read the 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.
- Being tested
- Nutritional Counseling
- Keywords
- Pregnancy, Obesity, Nutrition therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Obstetric Care | No intervention | Not described |
| Nutritional Counseling | Experimental | 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. Receives: Behavioral: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
change in weight from baseline prepregnancy weight
Measured: one year
Secondary outcomes (9)
Birth weight
Weight of infant at the time of birth
Measured: 40 weeks
Fetal anomalies
Ultrasound findings of fetal anomalies or those detected at birth
Measured: 40 weeks
Hypertensive disease of pregnancy
Development of hypertensive disease during pregnancy
Measured: 40 weeks
Gestational diabetes
Development of gestational diabetes
Measured: 40 weeks
Neonatal intensive care admission
Admission to neonatal intensive care unit
Measured: 28 days
APGAR scores
Measurement at birth
Measured: At birth
Mode of delivery
vaginal delivery or cesarean section
Measured: 40 weeks
Intrauterine Fetal Demise
Death of fetus prior to delivery
Measured: 40 weeks
Neonatal Death
Death of neonate from birth to 28 days of life
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abington Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin M. Murphy, MD, Abington Memorial Hospital
- Investigators
- Erin M Murphy, MD, Principal investigator, Abington Memorial HospitalBethany Perry, MD, Study director, Abington Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713712
- Sponsor's protocol ID
- 11-070
- Status last verified
- Apr 2013
- First submitted
- 6 Sep 2012
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ease of Access to Nutritional Services and the Effect on Maternal Weight in an Obese Urban Population
- ClinicalTrials.gov ID
- NCT01713712
- Acronym / sponsor ID
- 11-070
- Keywords
- Pregnancy, Obesity, Nutrition therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Abington Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 25 Oct 2012 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Obstetric Care | No intervention | – |
| Nutritional Counseling | Experimental | Behavioral: Nutritional CounselingPatients 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. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Nutritional CounselingPatients 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. | Behavioural | Nutritional Counseling |
Primary outcome
Weight gain
Time frame: one year
change in weight from baseline prepregnancy weight
9 secondary outcomes
Birth weight
Time frame: 40 weeks
Fetal anomalies
Time frame: 40 weeks
Hypertensive disease of pregnancy
Time frame: 40 weeks
Gestational diabetes
Time frame: 40 weeks
Neonatal intensive care admission
Time frame: 28 days
APGAR scores
Time frame: At birth
Mode of delivery
Time frame: 40 weeks
Intrauterine Fetal Demise
Time frame: 40 weeks
Neonatal Death
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
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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.
Erin M Murphy, MD principal investigator
Abington Memorial Hospital
Bethany Perry, MD study director
Abington Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Counseling in people with Pregnancy and Obesity, run by Abington Memorial Hospital at 2 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin M Murphy, MD (215-481-4211, emmurphy@amh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2013.