Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Alessandra Peccei, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01056406
First received: January 22, 2010
Last updated: May 7, 2013
Last verified: January 2010

January 22, 2010
May 7, 2013
December 2009
December 2014   (final data collection date for 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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01056406 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Prevalence of complications, specifically: -hypertension and eclampsia, -gestational diabetes, -caesarian delivery, -macrosomia -admission to neonatal intensive care unit (NICU) [ Time Frame: Throughout study participation ] [ Designated as safety issue: No ]
  • Initiation of breastfeeding [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Postpartum weight reduction in comparison to pre-pregnancy baseline weight (BMI) [ Time Frame: 6 month postpartum ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maintenance of improvements in physical activity as quantified by the nutrition and exercise questionnaire [ Time Frame: 6 weeks postpartum, 6 months postpartum ] [ Designated as safety issue: No ]
  • Maintenance of breastfeeding [ Time Frame: 6 weeks postpartum, 6 months postpartum ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Prevalence of complications, specifically: -hypertension and eclampsia, -gestational diabetes, -caesarian delivery, -macrosomia -admission to NICU [ Time Frame: Throughout study participation ] [ Designated as safety issue: No ]
  • Initiation of breastfeeding [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Postpartum weight reduction in comparison to pre-pregnancy baseline weight (BMI) [ Time Frame: 6 month postpartum ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maintenance of improvements in physical activity as quantified by the nutrition and exercise questionnaire [ Time Frame: 6 weeks postpartum, 6 months postpartum ] [ Designated as safety issue: No ]
  • Maintenance of breastfeeding [ Time Frame: 6 weeks postpartum, 6 months postpartum ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pregnancy
  • Overweight
  • Obesity
Behavioral: Nutrition Education
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.
  • No Intervention: Control Group
    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.
  • Experimental: Nutrition Education Group
    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.
    Intervention: Behavioral: Nutrition Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
300
January 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01056406
2009-P-002171/1; MGH
No
Alessandra Peccei, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Study Director: Alessandra Peccei, MD Partners HealthCare System at Massachusetts General Hospital
Massachusetts General Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP