Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy

Obesity Clinical Trial

Official title:

Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy: The Revere Pregnancy Weight Management Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01056406
• Other study ID #: 2009-P-002171/1; MGH
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 22, 2010
• Last updated: May 7, 2013
• Start date: December 2009
• Est. completion date: January 2015

Study information

• Verified date: January 2010
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pregnancy
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital HealthCare Center Revere	Revere	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of total weight gained during pregnancy compared to current Institute of Medicine Guidelines.		Weight at first prenatal care appointment. Weight at last obstetrical appointment prior to delivery.	No
Secondary	Overall improvement of the intake of nutritious foods as quantified by a written nutrition and exercise questionnaire.		Enrollment, 6 weeks postpartum, 6 months postpartum	No
Secondary	Prevalence of complications, specifically: -hypertension and eclampsia, -gestational diabetes, -caesarian delivery, -macrosomia -admission to neonatal intensive care unit (NICU)		Throughout study participation	No
Secondary	Initiation of breastfeeding		6 weeks postpartum	No
Secondary	Postpartum weight reduction in comparison to pre-pregnancy baseline weight (BMI)		6 month postpartum	No
Secondary	Maintenance of improvements in overall intake of nutritious foods as quantified by the nutrition and exercise questionnaire		6 weeks post partum, 6 months postpartum	No
Secondary	Maintenance of improvements in physical activity as quantified by the nutrition and exercise questionnaire		6 weeks postpartum, 6 months postpartum	No
Secondary	Maintenance of breastfeeding		6 weeks postpartum, 6 months postpartum	No