Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy
Condition: Pregnancy; Overweight; Obesity
MeSH terms: Overweight; Weight Gain
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Nutrition Education
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy; Overweight; Obese; Nutrition intervention