PregnancyNCT01056406
Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy
A study testing Nutrition Education in people with Pregnancy and Overweight, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if twice monthly interaction with a registered dietitian from 6-16 weeks gestation through 6 months postpartum will help women who are overweight or obese gain weight during pregnancy closer to the Institute of Medicine (IOM)guidelines and lose weight more effectively within… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Pregnancy, Overweight, Obesity
- What is being tested?
- Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2015
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women ages 18 to 49 with a BMI >25 and <40 at the first prenatal visit
- Women < 16 weeks gestation
- Both women who have and have not received previous nutritional counseling
- Both women who have and have not dieted in the past
- Women with a documented medical history or who report a history of disordered eating including over eating, night eating, or binge eating without a diagnosis listed in the "exclusion criteria" will not be excluded
Who cannot join
- Pregnant women over age 49
- Pregnant women ages 18 to 49 with a BMI <25 or > 40 at their first prenatal visit
- Women > 16 weeks gestation
- Women pregnant with multiples
- Diabetes prior to pregnancy
- Women with a documented medical history of an eating disorder including anorexia nervosa, bulimia nervosa, anorexia athletica, and orthorexia will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital HealthCare Center Revere
Revere, Massachusetts, 02151
About this study
Official title: Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy: The Revere Pregnancy Weight Management Study
The purpose of this study is to determine if twice monthly interaction with a registered dietitian from 6-16 weeks gestation through 6 months postpartum will help women who are overweight or obese gain weight during pregnancy closer to the Institute of Medicine (IOM)guidelines and lose weight more effectively within the 6 month postpartum period than those who do not receive twice monthly interaction with a registered dietitian during this period.
Overweight/obesity can lead to a number of adverse pregnancy, delivery and birth outcomes, including increased risk of hypertension, eclampsia, and diabetes during pregnancy, miscarriage, premature delivery, birth injuries, neural tube defects, and prenatal death. More than half of women of childbearing age are overweight or are obese. Women of color and low-income women are affected disproportionately.
Read more
Unfortunately, women know little, if anything, about the impact of overweight and obesity on pregnancy and health care providers are unsure how to effectively address the problem with their patients.
A limited number of programs have tested ways to effectively address weight gain management during pregnancy. None have been successful in addressing weight gain in women who are obese or overweight at the start of pregnancy. The 2-year Revere Health Center Pregnancy Weight Management Study will test the feasibility and efficacy of providing pregnant women who are overweight or obese with regular access to a registered dietitian during and after pregnancy to help achieve total weight gain closer to recommended guidelines and to ensure the best outcomes for the mother and her newborn.
Read the detailed description
The Revere Pregnancy and Weight Management Study has been designed to test the hypothesis that women with a BMI > 25 and < 40 who receive information about the risks of excessive weight gain during pregnancy and bimonthly interventions from a registered dietitian from the beginning of their pregnancy (6-16 weeks gestation) through 6 months postpartum, will achieve total weight gain closer to IOM (Institute of Medicine) guidelines and will have fewer complications as compared to women who only receive information about the risks of excessive weight gain (i.e. Current standard of optimal care). In addition, we hope to find that women who participate in the program will increase physical activity and show improvement in overall nutritious food choices as will be measured by the results of a nutrition and physical activity questionnaire completed by all participants at 3 points during the study.
This study will be managed completely by a registered dietitian who has experience working with pregnant women. The dietitian will have direct access to the participants' primary clinicians for consultation throughout the course of the study.
All patients, regardless of whether in the control or intervention group, will receive the optimal standard of prenatal and postpartum care and any additional care needed to ensure the best outcomes for the mother and newborn.
Everyone in the study will meet with the dietitian who works at the Revere Health Center at least one time. During the initial visit, participants will receive information about healthy eating and exercise during pregnancy. Women will also receive information about risks to mother and baby related to excessive weight gain during pregnancy for overweight and obese women.
Women in the control group will have no further interaction with the study dietitian.
Women in the intervention group will meet with the dietitian at least twice per month. The contact with the dietitian may include face-to-face individual counseling, telephone or e-mail follow-up, group classes or group activities.
Data that will be collected and analyzed will include:
- Demographic information
- Medical and Pregnancy History
- Pregnancy, labor, and delivery complications to mother and baby
- Birth record
- Weight change during pregnancy and after delivery
- Changes in physical activity and food choices
Through bimonthly contact with the dietitian, women will learn about healthier eating habits and exercise while monitoring weight gain to help adhere to IOM guidelines. We hope to see improved pregnancy, labor, and delivery outcomes for mothers and babies and help women achieve postpartum weight loss. We intend to foster an increased interest and knowledge about nutrition that will carry over to healthier food choices to share with their families and with other women.
- Conditions
- Pregnancy, Overweight, Obesity
- Being tested
- Nutrition Education
- Keywords
- Pregnancy, Overweight, Obese, Nutrition intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
Twice monthly interaction with study nutritionist (a registered dietitian) in the form of face-to-face individual nutrition counseling sessions, telephone and electronic follow-ups, option to attend group nutrition and group exercise classes.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Overweight and obese pregnant women who are randomly assigned to the control group will receive the current standard of optimal care in addition to 1 nutrition education session with the study nutritionist (a registered dietitian) at 6-16 weeks gestation. |
| Nutrition Education Group | Experimental | Overweight and obese pregnant women randomly assigned to the nutrition education group, in addition to the current standard of optimal care, will receive twice monthly interaction with the study nutritionist (a registered dietitian) from 6-16 weeks gestation through 6 months postpartum. Receives: Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of total weight gained during pregnancy compared to current Institute of Medicine Guidelines.
Measured: Weight at first prenatal care appointment. Weight at last obstetrical appointment prior to delivery.
Secondary outcomes (7)
Overall improvement of the intake of nutritious foods as quantified by a written nutrition and exercise questionnaire.
Measured: Enrollment, 6 weeks postpartum, 6 months postpartum
Prevalence of complications, specifically: -hypertension and eclampsia, -gestational diabetes, -caesarian delivery, -macrosomia -admission to neonatal intensive care unit (NICU)
Measured: Throughout study participation
Initiation of breastfeeding
Measured: 6 weeks postpartum
Postpartum weight reduction in comparison to pre-pregnancy baseline weight (BMI)
Measured: 6 month postpartum
Maintenance of improvements in overall intake of nutritious foods as quantified by the nutrition and exercise questionnaire
Measured: 6 weeks post partum, 6 months postpartum
Maintenance of improvements in physical activity as quantified by the nutrition and exercise questionnaire
Measured: 6 weeks postpartum, 6 months postpartum
Maintenance of breastfeeding
Measured: 6 weeks postpartum, 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2015
- Study completionDec 2015
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 PregnancyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Peccei, MD, Massachusetts General Hospital
- Investigators
- Alessandra Peccei, MD, Study director, Partners HealthCare System at Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056406
- Sponsor's protocol ID
- 2009-P-002171/1; MGH
- Status last verified
- Mar 2016
- First submitted
- 22 Jan 2010
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: in process
Publications
Peccei A, Blake-Lamb T, Rahilly D, Hatoum I, Bryant A. Intensive Prenatal Nutrition Counseling in a Community Health Setting: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):423-432. doi: 10.1097/AOG.0000000000002134.
PubMed 28697099
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy: The Revere Pregnancy Weight Management Study
- ClinicalTrials.gov ID
- NCT01056406
- Acronym / sponsor ID
- 2009-P-002171/1; MGH
- Conditions
- Pregnancy, Overweight, Obesity
- Keywords
- Pregnancy, Overweight, Obese, Nutrition intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jan 2010 (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 determine if twice monthly interaction with a registered dietitian from 6-16 weeks gestation through 6 months postpartum will help women who are overweight or obese gain weight during pregnancy closer to the Institute of Medicine (IOM)guidelines and lose weight more effectively within the 6 month postpartum period than those who do not receive twice monthly interaction with a registered dietitian during this period.
Overweight/obesity can lead to a number of adverse pregnancy, delivery and birth outcomes, including increased risk of hypertension, eclampsia, and diabetes during pregnancy, miscarriage, premature delivery, birth injuries, neural tube defects, and prenatal death. More than half of women of childbearing age are overweight or are obese. Women of color and low-income women are affected disproportionately.
Unfortunately, women know little, if anything, about the impact of overweight and obesity on pregnancy and health care providers are unsure how to effectively address the problem with their patients.
A limited number of programs have tested ways to effectively address weight gain management during pregnancy. None have been successful in addressing weight gain in women who are obese or overweight at the start of pregnancy. The 2-year Revere Health Center Pregnancy Weight Management Study will test the feasibility and efficacy of providing pregnant women who are overweight or obese with regular access to a registered dietitian during and after pregnancy to help achieve total weight gain closer to recommended guidelines and to ensure the best outcomes for the mother and her newborn.
Detailed description
The Revere Pregnancy and Weight Management Study has been designed to test the hypothesis that women with a BMI > 25 and < 40 who receive information about the risks of excessive weight gain during pregnancy and bimonthly interventions from a registered dietitian from the beginning of their pregnancy (6-16 weeks gestation) through 6 months postpartum, will achieve total weight gain closer to IOM (Institute of Medicine) guidelines and will have fewer complications as compared to women who only receive information about the risks of excessive weight gain (i.e. Current standard of optimal care). In addition, we hope to find that women who participate in the program will increase physical activity and show improvement in overall nutritious food choices as will be measured by the results of a nutrition and physical activity questionnaire completed by all participants at 3 points during the study.
This study will be managed completely by a registered dietitian who has experience working with pregnant women. The dietitian will have direct access to the participants' primary clinicians for consultation throughout the course of the study.
All patients, regardless of whether in the control or intervention group, will receive the optimal standard of prenatal and postpartum care and any additional care needed to ensure the best outcomes for the mother and newborn.
Everyone in the study will meet with the dietitian who works at the Revere Health Center at least one time. During the initial visit, participants will receive information about healthy eating and exercise during pregnancy. Women will also receive information about risks to mother and baby related to excessive weight gain during pregnancy for overweight and obese women.
Women in the control group will have no further interaction with the study dietitian.
Women in the intervention group will meet with the dietitian at least twice per month. The contact with the dietitian may include face-to-face individual counseling, telephone or e-mail follow-up, group classes or group activities.
Data that will be collected and analyzed will include:
- Demographic information
- Medical and Pregnancy History
- Pregnancy, labor, and delivery complications to mother and baby
- Birth record
- Weight change during pregnancy and after delivery
- Changes in physical activity and food choices
Through bimonthly contact with the dietitian, women will learn about healthier eating habits and exercise while monitoring weight gain to help adhere to IOM guidelines. We hope to see improved pregnancy, labor, and delivery outcomes for mothers and babies and help women achieve postpartum weight loss. We intend to foster an increased interest and knowledge about nutrition that will carry over to healthier food choices to share with their families and with other women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Overweight and obese pregnant women who are randomly assigned to the control group will receive the current standard of optimal care in addition to 1 nutrition education session with the study nutritionist (a registered dietitian) at 6-16 weeks gestation. |
| Nutrition Education Group | Experimental | Behavioral: Nutrition EducationOverweight and obese pregnant women randomly assigned to the nutrition education group, in addition to the current standard of optimal care, will receive twice monthly interaction with the study nutritionist (a registered dietitian) from 6-16 weeks gestation through 6 months postpartum. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women ages 18 to 49 with a BMI >25 and <40 at the first prenatal visit
- Women < 16 weeks gestation
- Both women who have and have not received previous nutritional counseling
- Both women who have and have not dieted in the past
- Women with a documented medical history or who report a history of disordered eating including over eating, night eating, or binge eating without a diagnosis listed in the "exclusion criteria" will not be excluded
Key exclusion criteria (6 listed)
- Pregnant women over age 49
- Pregnant women ages 18 to 49 with a BMI <25 or > 40 at their first prenatal visit
- Women > 16 weeks gestation
- Women pregnant with multiples
- Diabetes prior to pregnancy
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 |
|---|---|---|
| Nutrition EducationTwice monthly interaction with study nutritionist (a registered dietitian) in the form of face-to-face individual nutrition counseling sessions, telephone and electronic follow-ups, option to attend group nutrition and group exercise classes. | Behavioural | Nutrition Education Group |
Primary outcome
Percent of total weight gained during pregnancy compared to current Institute of Medicine Guidelines.
Time frame: Weight at first prenatal care appointment. Weight at last obstetrical appointment prior to delivery.
7 secondary outcomes
Overall improvement of the intake of nutritious foods as quantified by a written nutrition and exercise questionnaire.
Time frame: Enrollment, 6 weeks postpartum, 6 months postpartum
Prevalence of complications, specifically: -hypertension and eclampsia, -gestational diabetes, -caesarian delivery, -macrosomia -admission to neonatal intensive care unit (NICU)
Time frame: Throughout study participation
Initiation of breastfeeding
Time frame: 6 weeks postpartum
Postpartum weight reduction in comparison to pre-pregnancy baseline weight (BMI)
Time frame: 6 month postpartum
Maintenance of improvements in overall intake of nutritious foods as quantified by the nutrition and exercise questionnaire
Time frame: 6 weeks post partum, 6 months postpartum
Maintenance of improvements in physical activity as quantified by the nutrition and exercise questionnaire
Time frame: 6 weeks postpartum, 6 months postpartum
Maintenance of breastfeeding
Time frame: 6 weeks postpartum, 6 months 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 21 Mar 2016.
- Derived from this study: PubMed 28697099Peccei A, Blake-Lamb T, Rahilly D, Hatoum I, Bryant A. Intensive Prenatal Nutrition Counseling in a Community Health Setting: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):423-432. doi: 10.1097/AOG.0000000000002134.
- Individual participant dataSharing planned: Yes. in process
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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.
Alessandra Peccei, MD study director
Partners HealthCare System at Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education in people with Pregnancy and Overweight, run by Massachusetts General Hospital at 1 site 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 5 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: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percent of total weight gained during pregnancy compared to current Institute of Medicine Guidelines. (time frame: Weight at first prenatal care appointment. Weight at last obstetrical appointment prior to delivery.). 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 NCT01056406, 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 21 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.