Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy

NCT01056406 | Completed

• 1 other identifier: 2009-P-002171/1; MGH
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Overweight; Obesity

Keywords

Pregnancy; Overweight; Obese; Nutrition intervention

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• Overall improvement of the intake of nutritious foods as quantified by a written nutrition and exercise questionnaire.

  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)

  Throughout study participation

• Initiation of breastfeeding

  6 weeks postpartum

• Postpartum weight reduction in comparison to pre-pregnancy baseline weight (BMI)

  6 month postpartum

• Maintenance of improvements in overall intake of nutritious foods as quantified by the nutrition and exercise questionnaire

  6 weeks post partum, 6 months postpartum

Study Arms (2)

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.

Behavioral: Nutrition Education

Interventions

Nutrition Education BEHAVIORAL

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.

Nutrition Education Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital HealthCare Center Revere

Revere, Massachusetts, 02151, United States

Location

Related Publications (1)

• 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.

  PMID: 28697099 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Alessandra Peccei, MD

  Partners HealthCare System at Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alessandra Peccei, MD

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 21, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)