Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy

Completed · Not applicable

Conditions studied: Pregnancy, Overweight, Obesity

In brief

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.

Key facts

Study ID

NCT01056406

Run by

Massachusetts General Hospital

People needed

300

Starts

2009-12-01

Expected to finish

2015-12-01

Last updated by the study team

2016-03-21

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

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
• 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

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

Where it is running

• Massachusetts General Hospital HealthCare Center Revere — Revere, Massachusetts, United States

Full record on ClinicalTrials.gov

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