Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy



Status:Completed
Conditions:Obesity Weight Loss, Obesity Weight Loss, Women's Studies
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:18 - 49
Updated:4/21/2016
Start Date:December 2009
End Date:December 2015

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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.

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
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